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

Primary Purpose

Constipation

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Macrogol (Transipeg, BAY81-8430)

Macrogol (Forlax)

About this trial

This is an interventional treatment trial for Constipation focused on measuring Macrogol

Eligibility Criteria

6 Months - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Macrogol (Transipeg)

Macrogol (Forlax)

Arm Description

Outcomes

Primary Outcome Measures

Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks

Change From Baseline in Total Sum Score (TSS) at Week 52

Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline

Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline

Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline

Dose Range Determination: Mean Dose Based on Sachets Used

Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used

Secondary Outcome Measures

Percentage of Treatment Success

Individual Symptoms: Defecation Frequency

Individual Symptoms: Consistency of the Feces

Individual Symptoms: Strains During Defecation

Individual Symptoms: Quantity of Stools

Individual Symptoms: Percentage of Subjects With Pain During Defecation

Individual Symptoms: Frequency of Pain (Times per Week)

Percentage of Subjects With Abdominal Pain

Individual Symptoms: Frequency of Abdominal Pain (Times per Week)

Individual Symptoms: Relation of Abdominal Pain With Defecation

Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night

Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points

Individual Symptoms: Percentage of Subjects With Urgency for Defecation

Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)

Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night

Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)

Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite

Individual Symptoms: Average Score for Diary Reported Diarrhoea

Individual Symptoms: Average Score for Diary Reported Flatulence

Individual Symptoms: Average Score for Diary Reported Nausea

Full Information

NCT ID

NCT01810653

First Posted

March 12, 2013

Last Updated

August 12, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01810653

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

Macrogol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Macrogol (Transipeg)

Arm Type

Experimental

Arm Title

Macrogol (Forlax)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Macrogol (Transipeg, BAY81-8430)

Intervention Description

Up to 4 sachets per day based on individual titration

Intervention Type

Drug

Intervention Name(s)

Macrogol (Forlax)

Intervention Description

Up to 4 sachets per day based on individual titration

Primary Outcome Measure Information:

Title

Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks

Time Frame

Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52

Title

Change From Baseline in Total Sum Score (TSS) at Week 52

Time Frame

Baseline, Week 52

Title

Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline

Time Frame

Average of Weeks 1 to 8

Title

Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline

Time Frame

Average of Weeks 26 and 52

Title

Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline

Time Frame

Average up to 52 weeks

Title

Dose Range Determination: Mean Dose Based on Sachets Used

Time Frame

Up to 52 weeks.

Title

Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used

Time Frame

Up to 52 weeks

Secondary Outcome Measure Information:

Title

Percentage of Treatment Success

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Defecation Frequency

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Consistency of the Feces

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Strains During Defecation

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Quantity of Stools

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Percentage of Subjects With Pain During Defecation

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Frequency of Pain (Times per Week)

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Percentage of Subjects With Abdominal Pain

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Frequency of Abdominal Pain (Times per Week)

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Relation of Abdominal Pain With Defecation

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Percentage of Subjects With Urgency for Defecation

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite

Time Frame

Week 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Average Score for Diary Reported Diarrhoea

Time Frame

Week 0, 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Average Score for Diary Reported Flatulence

Time Frame

Week 0, 1, 2, 4, 8, 12, 26, 52

Title

Individual Symptoms: Average Score for Diary Reported Nausea

Time Frame

Week 0, 1, 2, 4, 8, 12, 26, 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

City

Woerden

ZIP/Postal Code

3447 GN

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

28906317

Citation

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.

Results Reference

derived

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

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

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

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