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Forlax versus Transipeg in constipated children.


- candidate number2743
- NTR NumberNTR1098
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2007
- Secondary IDsTransipeg-Forlax studie 
- Public TitleForlax versus Transipeg in constipated children.
- Scientific TitleForlax versus Transipeg in constipated children.
- ACRONYMN/A
- hypothesisForlax and transipeg are equally effective in treating childhood constipation.
- Healt Condition(s) or Problem(s) studiedConstipation, Abdominal pain, Fecal incontinence
- Inclusion criteria1. Infants between 6 months and 15 years;
2. Defecation frequency < 3/week;
3. No oral laxatives for 2 weeks;
4. No PEG-laxatives for 2 months.
- Exclusion criteria1. Metabolic disease;
2. functional non-retentive faecal incontinence;
3. mental retardation;
4. cerebral palsy;
5. anal anomalies;
6. Hirschsprung's disease.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-mrt-2006
- planned closingdate1-dec-2008
- Target number of participants100
- InterventionsNone, because the children would be treated by laxants anyway. For this reason we don't assusme treatment as an intervention.
- Primary outcome1. Defecation frequency;
2. Frequency of faecal incontinence episodes.
- Secondary outcomeAbdominal pain.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES N. Bekkali
- CONTACT for SCIENTIFIC QUERIES N. Bekkali
- Sponsor/Initiator Academic Medical Center (AMC), Emma Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Emma Children's Hospital
- PublicationsN/A
- Brief summaryChildren presenting at the outpatient clinics of the gastroenterology of the Emma Children's hospital will be randomised to either Forlax or Transipeg as a laxans therapy. The difference between the two agents in success will be evaluated at the end of the study.
- Main changes (audit trail)
- RECORD11-sep-2007 - 25-mrt-2008


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