Status:
COMPLETED
A Study to Compare the Effect of Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation
Lead Sponsor:
Bayer
Conditions:
Constipation
Eligibility:
All Genders
6-15 years
Phase:
PHASE4
Brief Summary
The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits w...
Eligibility Criteria
Inclusion
- Childhood functional constipation
- 6 months to \<16 years of age
- Male or female
- For females of childbearing potential (after menarche): negative pregnancy test
- Moderately severe to severe constipation, defined as stool frequency \<3 stools/week
- Informed consent signed by parent(s) or legal acceptable representative(s), after sufficient oral and written information before entering the study, to be documented by the investigators in the Case Report Form
Exclusion
- Functional non-retentive fecal incontinence
- Known metabolic or endocrine disorders (s.a. hypothyroidism)
- Neurologic disorders (s.a. spina bifida or spinal cord anomaly)
- Hirschsprung's disease (congenital megacolon)
- Anal anomaly
- Gastrointestinal surgery
- Drug induced constipation
- Mental retardation
- Cerebral palsy
- Treatment with other laxatives
- Drugs influencing gastrointestinal function (e.g., cisapride, erythromicin, imodium)
- Prior bowel surgery, except appendectomy
- Earlier participation in this trial
- Concurrent participation in any other clinical trial
- Participation in any other clinical study 6 months prior to inclusion
- Any use of a Macrogol within 2 months prior to inclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01810653
Start Date
April 1 2006
End Date
December 1 2008
Last Update
August 13 2015
Active Locations (4)
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1
Amsterdam, Netherlands, 1105 AZ
2
Eindhoven, Netherlands, 5623 EJ
3
Veldhoven, Netherlands, 5504 DB
4
Woerden, Netherlands, 3447 GN