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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Macrogol (Transipeg)

Group Type EXPERIMENTAL

Macrogol (Transipeg, BAY81-8430)

Intervention Type DRUG

Up to 4 sachets per day based on individual titration

Macrogol (Forlax)

Group Type ACTIVE_COMPARATOR

Macrogol (Forlax)

Intervention Type DRUG

Up to 4 sachets per day based on individual titration

Interventions

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Macrogol (Transipeg, BAY81-8430)

Up to 4 sachets per day based on individual titration

Intervention Type DRUG

Macrogol (Forlax)

Up to 4 sachets per day based on individual titration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No