A Study to Compare the Effect of Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

Bayer

Status and phase

Completed

Phase 4

Conditions

Constipation

Treatments

Drug: Macrogol (Forlax)

Drug: Macrogol (Transipeg, BAY81-8430)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01810653

12052

2015-000081-63 (EudraCT Number)

Details and patient eligibility

About

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 were used for the comparison of long-term safety between the groups.

Enrollment

97 patients

Sex

All

Ages

6 months to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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