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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01116206
Registration number
NCT01116206
Ethics application status
Date submitted
3/05/2010
Date registered
4/05/2010
Date last updated
21/03/2017
Titles & IDs
Public title
An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation
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Scientific title
A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation
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Secondary ID [1]
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PRUCRC3001
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Secondary ID [2]
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CR017173
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Universal Trial Number (UTN)
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Trial acronym
Resolor
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Constipation
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Prucalopride
Treatment: Drugs - Placebo
Experimental: Prucalopride - prucalopride 2- milligram (mg), orally once daily for 12 weeks
Placebo Comparator: Placebo - Matching placebo, orally once daily for 12 weeks
Treatment: Drugs: Prucalopride
2 mg tablet, orally once daily, for 12 weeks
Treatment: Drugs: Placebo
1 tablet, orally once dailyfor 12 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an Average of 3 or More Spontaneous Complete Bowel Movements (SCBMs)
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Assessment method [1]
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Percentage of responders (responders: participants with an average of 3 or more SCBMs per week) will be assessed during 12-week double-blind treatment phase (total treatment duration). SCBM is defined as a Spontaneous Bowel Movement (SBM) associated with a sense of complete evacuation. SBM is defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository used on either the calendar day of the BM or the calendar day before the BM. The total number of SBMs associated with a feeling of complete evacuation will be summed and divided by 12. Average weekly frequency of SCBMs will be calculated as number of SCBMs in treatment phase multiplied by 7 divided by total number of evaluable days in treatment phase.
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Timepoint [1]
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Week 1 to 12
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Secondary outcome [1]
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Percentage of Participants With an Average of 3 or More SCBMs During the First 4 Weeks
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Assessment method [1]
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Percentage of responders (participants with an average of 3 or more SCBMs per week) will be assessed during first 4 weeks of 12-week double-blind treatment phase (total treatment duration). SCBM will be defined as a Spontaneous Bowel Movement (SBM) associated with a sense of complete evacuation. SBM is defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository used on either the calendar day of the BM or the calendar day before the BM. Average weekly frequency of SCBMs will be calculated as number of SCBMs in Week 1 to 4 multiplied by 7 divided by total number of evaluable days in Week 1 to 4.
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Timepoint [1]
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Week 1 to 4
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Secondary outcome [2]
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Percentage of Participants With an Average Increase of 1 or More Bowel Movements (BMs)
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Assessment method [2]
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Percentage of participants with an average increase of 1 or more SCBMs per week as compared to the run-in phase (that is screening phase at Week Minus 2) will be assessed. SCBM is defined as SBM that is associated with a sense of complete evacuation. SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. Average weekly frequencies will be calculated as number of SCBMs in interval multiplied by 7 divided by total number of evaluable days in interval.
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Timepoint [2]
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Week 1 to 12
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Secondary outcome [3]
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Percentage of Participants With an Average of 3 or More SCBMs During Weeks 5 to 8 and 9 to 12
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Assessment method [3]
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Percentage of participants with an average increase of 3 or more SCBMs per week will be assessed. SCBM is defined as SBM that is associated with a sense of complete evacuation. SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. Average weekly frequencies will be calculated as number of SCBMs in interval multiplied by 7 and divided by total number of evaluable days in interval.
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Timepoint [3]
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Week 5 to Week 8 and Week 9 to Week 12
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Secondary outcome [4]
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Average Number of SCBMs
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Assessment method [4]
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An increase in the average number of SCBMs per week will be assessed during Weeks 1 to 12. SCBM will be defined as a SBM that is associated with a sense of complete evacuation. SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. Average weekly frequencies will be calculated as (number of SCBMs in interval * 7) / number of evaluable days in interval.
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Timepoint [4]
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Week 1 to 12
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Secondary outcome [5]
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Average Number of Spontaneous Bowel Movements (SBMs)
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Assessment method [5]
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Average number of SBMs is assessed. SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. Average weekly frequencies will be calculated as (number of SBMs in interval * 7) / number of evaluable days in interval.
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Timepoint [5]
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Week 1 to 12
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Secondary outcome [6]
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Average Number of all Bowel Movements (BMs)
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Assessment method [6]
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Average number of BMs will be assessed.BMs are spontaneous discharge of waste matterfrom the large intestine. Average weekly frequencies will be calculated as (number of BMs in interval * 7) / number of evaluable days in interval.
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Timepoint [6]
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Week 1 to 12
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Secondary outcome [7]
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Time-to-First SCBM and Time-to-First Week With 3 or More SCBMs After the First Dose of the Study Drug
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Assessment method [7]
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SCBM is defined as a SBM that is associated with a sense of complete evacuation. SBM is defined as a bowel movement BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. Average weekly frequencies will be calculated as (number of SCBMs in interval * 7) / number of evaluable days in interval.
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Timepoint [7]
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Week 1 to 12
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Secondary outcome [8]
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Average Number of Bisacodyl Tablets
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Assessment method [8]
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Average number of bisacodyl tablets taken is determined. Bisacodyl 5, 10, or 15 milligram (mg) is used as rescue medication. Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Average weekly frequencies will be calculated as (number of bisacodyl tablets in interval * 7) / number of evaluable days in interval.
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Timepoint [8]
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Week 1 to 12
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Secondary outcome [9]
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Percentage of Participants With Zero, Less Than (<) 2 and Greater Than and Equal to (>=) 2 Tablets of Bisacodyl Taken
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Assessment method [9]
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Average number of bisacodyl tablets taken will be determined during 12-week double-blind treatment phase. Bisacodyl 5, 10, or 15 milligram (mg) will be used as rescue medication. Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Average weekly frequencies will be calculated as (number of bisacodyl tablets in interval * 7) / number of evaluable days in interval.
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Timepoint [9]
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Week 1 to 12
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Secondary outcome [10]
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Percentage of BMs With Normal Consistency
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Assessment method [10]
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Percentage of BM with normal consistency for each participant will be calculated by dividing number of BMs with normal consistency with total number of BMs in that participant multiplied by 100. Average of percentage of BM with normal consisitency for all participants have been reported. The consistency of each BM will be assessed using the 7-point Bristol Stool Scale: score ranging from 1 to 7,wherein 1=stool is separate hard lumps, like nuts (hard to pass); and 7=watery, no solid pieces, entirely liquid (passed easily). Score 3 and 4 indicates normal consistency.
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Timepoint [10]
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Week 1 to 12
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Secondary outcome [11]
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Percentage of BMs With Less Straining
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Assessment method [11]
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Percentage of BM with less straining for each participant will be calculated by dividing number of BMs with less straining with total number of BMs in that participant multiplied by 100. Average of percentage of BM with less straining for all participants will be reported. Degree of straining is measured on a 5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Less straining indicates none or mild degree of straining.
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Timepoint [11]
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Week 1 to 12
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Secondary outcome [12]
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Percentage of BMs with a Sensation of Complete Evacuation
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Assessment method [12]
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Percentage of BM with a sensation of complete evacuation for each participant will be calculated by dividing number of BMs with a sensation of complete evacuation with total number of BMs in that participant multiplied by 100. Average of percentage of BM with a sensation of complete evacuation for all participants will be reported. Percentage of BMs with a sensation of complete evacuation will be calculated as (number of BMs with a sensation of complete evacuation in interval / [number of SCBMs or BMs with non - missing scores in interval] * 100%).
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Timepoint [12]
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Week 1 to 12
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Secondary outcome [13]
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Participants Global Assessment on Consistency of Stool
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Assessment method [13]
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Participants Global Assessment on consistency of stool will be assessed with Types 1-2=constipation,Types 3-4= ideal stools and Types 5-7=further tending towards diarrhea or urgency based on Bristol Stool Scale. Bristol Stool Scale:1=stool is separate hard lumps, like nuts (hard to pass);2=stool is sausage-shaped but lumpy; 3=stool is like a sausage but with cracks on its surface; 4=stool is like a sausage or snake, smooth and soft; 5=stool is soft blobs with clear-cut edges (passed easily);6=fluffy pieces with ragged edges, mushy stool;7=watery, no solid pieces, entirely liquid (passed easily).
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Timepoint [13]
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Week 2, 4, 8 and 12
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Secondary outcome [14]
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Participants Global Assessment on Severity of Constipation
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Assessment method [14]
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Participants Global Assessmentof severity of constipation will be assessed using a 5-point scale ranging from 0 to 4: 0=absent (no constipation); 1=mild constipation; 2=moderate constipation; 3=severe constipation; 4=very severe constipation.
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Timepoint [14]
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Week 2, Week 4, Week 8 and Week 12
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Secondary outcome [15]
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Participants Global Assessment on Efficacy of Treatment
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Assessment method [15]
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Participants global assessment on efficacy of treatment was assessed using a 5-point scale ranging from 0 to 5: 0=not at all effective; 1=a little bit effective; 2=moderately effective; 3=quite a bit effective; 4=extremely effective.
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Timepoint [15]
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Week 2, Week 4, Week 8, and Week 12
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Secondary outcome [16]
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Investigator's Global Assessment on Efficacy of Treatment
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Assessment method [16]
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Investigator's Global Assessment on efficacy of treatment will be assessed using rating on a 5-point scale: 0=not at all effective; 1=a little bit effective; 2=moderately effective; 3=quite a bit effective; 4=extremely effective
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Timepoint [16]
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Week 4 and 12
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Secondary outcome [17]
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Change From Baseline in Patient Assessment of Constipation-Symptom Questionnaire (PAC-SYM) Total Score at Week 2, 4, 8 and 12
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Assessment method [17]
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The PAC-SYM is a 12-item participant self-administered instrument that measures the severity of constipation-related symptoms. Items are rated on a 5-point Likert scale, where 0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe. The PAC-SYM contains 3 subscales: stool symptoms (5 items), abdominal symptoms (4 items) and rectal symptoms (3 items)
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Timepoint [17]
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Baseline, Week 2, 4, 8, and 12
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Secondary outcome [18]
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Change From Baseline in the PAC-SYM Subscale Scores at Week 2, 4, 8 and 12
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Assessment method [18]
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The PAC-SYM is comprised of the following 3 subscales: Stool symptoms (5 items): bowel movements that require straining or squeezing, bowel movements that are too hard, bowel movements that are too small, bowel movements that result in a sensation of incomplete evacuation, the feeling of having to pass a bowel movement but couldn't (false alarm); Abdominal symptoms (4 items):abdominal discomfort, abdominal pain, abdominal cramping, abdominal bloating; Rectal symptoms (3 items): painful bowel movements, rectal burning, bleeding or tearing during or after a bowel movement.
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Timepoint [18]
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Baseline, Week 2, 4, 8, and 12
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Secondary outcome [19]
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Percentage of Participant's who Rated Study Drug effectiveness
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Assessment method [19]
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The percentage of participants who rated the study treatment with efficacy score of 3=quite a bit to 4=extremely effective on global evaluation of efficacy of treatment was determined.
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Timepoint [19]
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Week 2, Week 4, Week 8 and Week 12
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Secondary outcome [20]
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Percentage of Participants With PAC SYM Score
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Assessment method [20]
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Percentage of participants with an improvement of greater than or equal to 1 point on the PAC SYM score will be determined. The PAC-SYM is a 12-item participant self-administered instrument that measures the severity of constipation-related symptoms. Items are rated on a 5-point Likert scale, where 0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe. The PAC-SYM contains 3 subscales: stool symptoms (5 items), abdominal symptoms (4 items) and rectal symptoms (3 items).
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Timepoint [20]
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Weeks 2, 4, 8, and 12
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Eligibility
Key inclusion criteria
- History of chronic constipation, defined as on average, 2 or fewer spontaneous bowel
movements (SBMs) per week and 1 or more of the following for at least a quarter of the
time for the last 3 months, while symptom onset was more than 6 months before the
screening visit: in more than 25 percent (%) of BMs, participants had very hard
(little balls) and/or hard stools, sensation of incomplete evacuation, straining at
defecation (making a bowel movement), sensation of ano-rectal obstruction or blockade,
and/or need for digital manipulation to facilitate evacuation
- Participants who were considered as constipated (who never had SBMs)
- Participant's constipation is functional
- Participants with the diagnosis of irritable bowel syndrome (bowel disorder in which
there is pain and diarrhea or constipation) with constipation and with no other
organic diseases can potentially be included depending on the decision of the
investigator
- Female participants must be postmenopausal (for at least 1 year) or surgically sterile
or practicing a highly effective method of birth control
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Secondary to other diseases/conditions (endocrine disorders, metabolic disorders or
neurologic disorders or drug-induced or suspected organic disorders of the large
bowel, i.e., obstruction, carcinoma (type of cancer), or inflammatory bowel disease)
- - Participants Using or intending to use disallowed medications that may influence the
bowel habit during the study
- Participants with severe (very serious, life threatening) and clinically uncontrolled
cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including
active alcohol or drug abuse), cancer (abnormal tissue that grows and spreads in the
body until it kills) or acquired immune deficiency syndrome (AIDS: illness that
results in decreased ability of the body to protect itself from other illnesses;
development of the disease or conditions associated with the disease results from
Human Immunodeficiency Virus [HIV]), or other gastrointestinal or endocrine disorders
- Participants with impaired renal function, that is, serum creatinine greater than 2
milligram per deciliter (greater than 180 micro mole per liter)
- Participants with clinically significant abnormalities of hematology, urinalysis, or
blood chemistry
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2011
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Sample size
Target
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Accrual to date
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Final
507
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Box Hill
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Recruitment hospital [3]
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- Kingswood
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Recruitment hospital [4]
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- Kogarah
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Recruitment hospital [5]
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- Newcastle
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Recruitment hospital [6]
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- Parkville
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Recruitment hospital [7]
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- Prahran
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Recruitment hospital [8]
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- Sydney
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Box Hill
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Recruitment postcode(s) [3]
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- Kingswood
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Recruitment postcode(s) [4]
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- Kogarah
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Recruitment postcode(s) [5]
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- Newcastle
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Recruitment postcode(s) [6]
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- Parkville
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Recruitment postcode(s) [7]
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- Prahran
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Recruitment postcode(s) [8]
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- Sydney
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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0
Chongqing
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Country [3]
0
0
China
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State/province [3]
0
0
Guangzhou
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Country [4]
0
0
China
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State/province [4]
0
0
Hangzhou
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Country [5]
0
0
China
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State/province [5]
0
0
Hefei
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Country [6]
0
0
China
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State/province [6]
0
0
Jinan
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Country [7]
0
0
China
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State/province [7]
0
0
Nanjing
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Country [8]
0
0
China
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State/province [8]
0
0
Shanghai
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Country [9]
0
0
China
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State/province [9]
0
0
Wuhan
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Country [10]
0
0
China
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State/province [10]
0
0
Xian
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Country [11]
0
0
Korea, Republic of
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State/province [11]
0
0
Busan
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Country [12]
0
0
Korea, Republic of
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State/province [12]
0
0
Dae-Gu
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Country [13]
0
0
Korea, Republic of
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State/province [13]
0
0
Deajun
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Country [14]
0
0
Korea, Republic of
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State/province [14]
0
0
Gwangju-Si
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Country [15]
0
0
Korea, Republic of
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State/province [15]
0
0
Iksan
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Country [16]
0
0
Korea, Republic of
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State/province [16]
0
0
Seoul
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Country [17]
0
0
Taiwan
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State/province [17]
0
0
Taipei
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Country [18]
0
0
Thailand
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State/province [18]
0
0
Bamgkok
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Country [19]
0
0
Thailand
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State/province [19]
0
0
Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of prucalopride to placebo
(an inactive substance that is compared with a drug to test whether the drug has a real
effect in a clinical trial) in treatment of participants with chronic (very serious, life
threatening) constipation (decreased number of or difficulty making bowel [the intestine]
movements).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01116206
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
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Address
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Country
0
0
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Phone
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0
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Fax
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0
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Email
0
0
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01116206
Download to PDF