Back to resultsTo Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
PEG 4000 (Forlax®)
Lactulose active and Lactulose placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation
Eligibility Criteria
Inclusion Criteria: Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis) Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy Exclusion Criteria: Organic bowel diseases Suspected GI obstruction History of GI surgery
Sites / Locations
- Ramathibodi Hospital, Mahidol University,
- Maharat Nakhon Ratchasima Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Bowel movement frequency
Secondary Outcome Measures
Subjective symptoms associated with defecation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00255372
Brief Title
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
Official Title
Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-blind, Lactulose Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 20, 2008 (Actual)
Study Completion Date
May 20, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PEG 4000 (Forlax®)
Intervention Description
Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
Intervention Type
Drug
Intervention Name(s)
Lactulose active and Lactulose placebo
Intervention Description
Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.
Primary Outcome Measure Information:
Title
Bowel movement frequency
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Subjective symptoms associated with defecation.
Time Frame
At every visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis)
Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy
Exclusion Criteria:
Organic bowel diseases
Suspected GI obstruction
History of GI surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Ramathibodi Hospital, Mahidol University,
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Maharat Nakhon Ratchasima Hospital
City
Nakhon Ratchasima
ZIP/Postal Code
30000
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
24943105
Citation
Treepongkaruna S, Simakachorn N, Pienvichit P, Varavithya W, Tongpenyai Y, Garnier P, Mathiex-Fortunet H. A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children. BMC Pediatr. 2014 Jun 19;14:153. doi: 10.1186/1471-2431-14-153.
Results Reference
derived
Learn more about this trial
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
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