To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-blind, Lactulose Controlled Study.
1 other identifier
interventional
88
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2005
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2008
CompletedApril 24, 2020
April 1, 2020
3.1 years
November 17, 2005
April 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Bowel movement frequency
week 4
Secondary Outcomes (1)
Subjective symptoms associated with defecation.
At every visit
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Organic bowel diseases
- Suspected GI obstruction
- History of GI surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (2)
Ramathibodi Hospital, Mahidol University,
Bangkok, 10400, Thailand
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, 30000, Thailand
Related Publications (1)
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.
PMID: 24943105DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 18, 2005
Study Start
April 1, 2005
Primary Completion
May 20, 2008
Study Completion
May 20, 2008
Last Updated
April 24, 2020
Record last verified: 2020-04