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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/NCT01880424
Registration number
NCT01880424
Ethics application status
Date submitted
12/06/2013
Date registered
19/06/2013
Date last updated
27/09/2016
Titles & IDs
Public title
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
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Scientific title
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
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Secondary ID [1]
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ICP-103-307
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Universal Trial Number (UTN)
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Trial acronym
D5630C00001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome With Constipation (IBS-C)
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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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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Linaclotide
Placebo Comparator: controlled arm -
Experimental: treatment arm -
Treatment: Drugs: Placebo
matching Placebo Capsules, Oral, once daily
Treatment: Drugs: Linaclotide
Linaclotide 290 ug Capsules, Oral, once daily
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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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12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
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Assessment method [1]
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A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of =30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period.
Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
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Timepoint [1]
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Baseline and Weeks 1-12 during the Treatment Period
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Primary outcome [2]
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12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
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Assessment method [2]
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A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period.
Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
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Timepoint [2]
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Baseline and Weeks 1-12 during the Treatment Period
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Secondary outcome [1]
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Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
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Assessment method [1]
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The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period).
A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation.
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Timepoint [1]
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Baseline and 12-week Treatment Period
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Secondary outcome [2]
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Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
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Assessment method [2]
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The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period).
SBM is defined as a bowel movement without laxative use in the preceding 24 hours.
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Timepoint [2]
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Baseline and 12-week Treatment Period
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Secondary outcome [3]
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Change From Baseline in 12-week Stool Consistency
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Assessment method [3]
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The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale [BSFS] score from the SBMs occurring during the 12-week Treatment Period).
Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts [difficult to pass] to 7=Watery, no solid pieces [entirely liquid]).
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Timepoint [3]
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Baseline and 12-week Treatment Period
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Secondary outcome [4]
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Change From Baseline in 12-week Severity of Straining
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Assessment method [4]
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The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period).
Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount).
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Timepoint [4]
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Baseline and 12-week Treatment Period
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Secondary outcome [5]
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Change From Baseline in 12-week Abdominal Bloating
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Assessment method [5]
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The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period).
Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.
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Timepoint [5]
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Baseline and 12-week Treatment Period
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Secondary outcome [6]
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Change From Baseline in 12-week Abdominal Pain
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Assessment method [6]
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The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period).
Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
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Timepoint [6]
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Baseline and 12-week Treatment Period
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Secondary outcome [7]
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Change From Baseline in 12-week Abdominal Discomfort
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Assessment method [7]
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The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period).
Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
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Timepoint [7]
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Baseline and 12-week Treatment Period
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Eligibility
Key inclusion criteria
1. Patient has signed an Informed Consent Form(ICF).
2. Patient Must not be pregnant or breastfeeding and agree to use birth control
3. Patient meets the colonoscopy requirements defined by the American Gastroenterological
Association guidelines and no clinically-significant laboratory or physical
examination findings;
4. Patient meets protocol-defined criteria for Irritable Bowel Syndrome with
Constipation(IBS-C), including stool frequency, straining, stool consistency,
abdominal pain, and abdominal discomfort criteria
5. Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from
making any new, major life-style changes that may affect IBS-C symptoms
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Recent history of mushy or watery stools
2. Various medical conditions, medical histories, or family medical histories that would
not make the patient a good candidate for the study
3. Patient currently has both unexplained and clinically significant alarm symptoms or
systemic signs of infection or colitis.
4. Surgery to the gastrointestinal tract
5. Usage of prohibited medications
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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 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
1/07/2013
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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
1/05/2015
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Sample size
Target
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Accrual to date
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Final
1722
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Adelaide
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Recruitment hospital [2]
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Research Site - Brisbane
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Recruitment hospital [3]
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Research Site - Five Dock
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Recruitment hospital [4]
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Research Site - Malvern
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Recruitment hospital [5]
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Research Site - Maroubra
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Recruitment hospital [6]
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Research Site - Melbourne
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Recruitment hospital [7]
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Research Site - Parkville
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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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- Brisbane
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Recruitment postcode(s) [3]
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- Five Dock
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- Malvern
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Recruitment postcode(s) [5]
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- Maroubra
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Recruitment postcode(s) [6]
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- Melbourne
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Recruitment postcode(s) [7]
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- Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Ontario
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China
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Beijing
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China
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Changsha
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China
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Chengdu
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China
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Chongqing
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China
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Guangzhou
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China
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Hangzhou
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China
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Harerbin
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China
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Hefei
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Jinan
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Nanchang
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Qingdao
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Shanghai
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Shenyang
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Shijiazhuang
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Wuhan
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China
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Xi An
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China
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Xiamen
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New Zealand
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Auckland
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Christchurch
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Dunedin
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Tauranga
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New Zealand
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Ironwood Pharmaceuticals, Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical trial is an international, multicenter, randomized, double-blind,
placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo.
Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be
randomized at up to 60 trial centers in China, Australia, and New Zealand.
The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12
weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment
Period, patients meeting the entry criteria for this trial will be randomized to one of two
double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01880424
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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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Yunsheng Yang
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Address
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Chinese PLA General Hospital
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01880424
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