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

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: Macrogol (Transipeg, BAY81-8430); Drug: Macrogol (Forlax)

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
  • Eindhoven, Netherlands, 5623 EJ
  • Veldhoven, Netherlands, 5504 DB
  • Woerden, Netherlands, 3447 GN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Macrogol (Transipeg)	Drug: Macrogol (Transipeg, BAY81-8430); Up to 4 sachets per day based on individual titration
ACTIVE_COMPARATOR: Macrogol (Forlax)	Drug: Macrogol (Forlax); Up to 4 sachets per day based on individual titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks	Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
Change From Baseline in Total Sum Score (TSS) at Week 52	Baseline, Week 52
Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline	Average of Weeks 1 to 8
Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline	Average of Weeks 26 and 52
Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline	Average up to 52 weeks
Dose Range Determination: Mean Dose Based on Sachets Used	Up to 52 weeks.
Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Treatment Success	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Defecation Frequency	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Consistency of the Feces	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Strains During Defecation	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Quantity of Stools	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Pain During Defecation	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Pain (Times per Week)	Week 1, 2, 4, 8, 12, 26, 52
Percentage of Subjects With Abdominal Pain	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Abdominal Pain (Times per Week)	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Relation of Abdominal Pain With Defecation	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Urgency for Defecation	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite	Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Average Score for Diary Reported Diarrhoea	Week 0, 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Average Score for Diary Reported Flatulence	Week 0, 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Average Score for Diary Reported Nausea	Week 0, 1, 2, 4, 8, 12, 26, 52

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Bekkali NLH, Hoekman DR, Liem O, Bongers MEJ, van Wijk MP, Zegers B, Pelleboer RA, Verwijs W, Koot BGP, Voropaiev M, Benninga MA. Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):10-15. doi: 10.1097/MPG.0000000000001726.

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (ESTIMATE): March 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 12, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Macrogol
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 12052; 2015-000081-63 (EUDRACT_NUMBER)