Chronic Constipation
Conditions
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.
Interventions
DRUGPEG 4000 (Forlax®)
Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
DRUGLactulose active and Lactulose placebo
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.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel movement frequency | week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptoms associated with defecation. | At every visit |
Countries
Thailand
Outcome results
None listed