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

Constipation Clinical Trial

Official title:

A Double-blind, Randomized, Uninational, Multicenter, Two Parallel Groups, Active Controlled Study to Compare the Effect of the Treatment With Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810653
• Other study ID #: 12052
• Secondary ID: 2015-000081-63
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2013
• Last updated: August 12, 2015
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Macrogol (Transipeg, BAY81-8430)
Up to 4 sachets per day based on individual titration
• Macrogol (Forlax)
Up to 4 sachets per day based on individual titration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks		Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
Primary	Change From Baseline in Total Sum Score (TSS) at Week 52		Baseline, Week 52
Primary	Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline		Average of Weeks 1 to 8
Primary	Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline		Average of Weeks 26 and 52
Primary	Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline		Average up to 52 weeks
Primary	Dose Range Determination: Mean Dose Based on Sachets Used		Up to 52 weeks.
Primary	Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used		Up to 52 weeks
Secondary	Percentage of Treatment Success		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Defecation Frequency		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Consistency of the Feces		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Strains During Defecation		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Quantity of Stools		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Percentage of Subjects With Pain During Defecation		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Frequency of Pain (Times per Week)		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Percentage of Subjects With Abdominal Pain		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Frequency of Abdominal Pain (Times per Week)		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Relation of Abdominal Pain With Defecation		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Percentage of Subjects With Urgency for Defecation		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite		Week 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Average Score for Diary Reported Diarrhoea		Week 0, 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Average Score for Diary Reported Flatulence		Week 0, 1, 2, 4, 8, 12, 26, 52
Secondary	Individual Symptoms: Average Score for Diary Reported Nausea		Week 0, 1, 2, 4, 8, 12, 26, 52

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