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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/NCT00403897




Registration number
NCT00403897
Ethics application status
Date submitted
24/11/2006
Date registered
27/11/2006
Date last updated
16/04/2008

Titles & IDs
Public title
An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
Scientific title
An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children
Secondary ID [1] 0 0
99/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Constipation 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Polyethylene glycol 3350 Na bicarbonate NaCl KCl

Experimental: 1 - Ages 2 - 6: Day 1= 1 sachet/day; Day 3= 1 sachet BID; Day 5= 1 sachet TID Ages 7 - 11: Day 1= 1 sachet BID; Days 3 & 5 = 2 sachets BID;


Treatment: Drugs: Polyethylene glycol 3350 Na bicarbonate NaCl KCl
6.9g sachet, oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Assessment of
Timepoint [1] 0 0
Secondary outcome [2] 0 0
abdominal pain
Timepoint [2] 0 0
Secondary outcome [3] 0 0
amount of stool
Timepoint [3] 0 0
Secondary outcome [4] 0 0
faecal form (Bristol stool scale)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
rectal bleeding
Timepoint [5] 0 0
Secondary outcome [6] 0 0
pain on defaecation
Timepoint [6] 0 0
Secondary outcome [7] 0 0
straining on defaecation
Timepoint [7] 0 0
Secondary outcome [8] 0 0
stool withholding
Timepoint [8] 0 0
Secondary outcome [9] 0 0
faecal incontinence (soiling)
Timepoint [9] 0 0
Secondary outcome [10] 0 0
efficacy (investigator and parental assessment)
Timepoint [10] 0 0
Secondary outcome [11] 0 0
concomitant laxative treatment
Timepoint [11] 0 0

Eligibility
Key inclusion criteria
- children aged 24 months - 11 years old inclusive

- patients with constipation defined as:

- = 2 spontaneous complete bowel movements per week (over the previous 14 days),
and one or more of the following:

- 1/4 or more of bowel movements with straining

- 1/4 or more of bowel movements with hard or lumpy stools

- patients in whom these symptoms have been present for = 3 months

- new patients or those whose management is unsatisfactory on current laxative treatment

- patients of either sex

- patients of any ethnic origin

- hospital in-patients or outpatients.
Minimum age
24 Months
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with:

- history of bowel washout within the last 2 months

- intestinal perforation or history of obstruction

- recent history of urinary tract infection (within last month)

- Hirschsprungs disease

- paralytic ileus

- toxic megacolon

- severe inflammatory conditions of the intestinal tract

- clinically uncontrolled renal/hepatic/cardiac disease(s)

- clinically uncontrolled endocrine disorder(s)

- any other severe unstable co-existing disease

- hypersensitivity to macrogol or other constituents of Movicol

- encopresis

- patients who have taken any investigational drug in the last three months

- patients or patients whose parents would in the opinion of the investigator be unable
to comply with the requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Norgine
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment
of chronic constipation in children.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00403897
Trial related presentations / publications
Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.
Public notes

Contacts
Principal investigator
Name 0 0
Winita Hardikar, MD
Address 0 0
Royal Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00403897