check_circleStudy Completed

Constipation

Bayer Identifier:

12052

ClinicalTrials.gov Identifier:

NCT01810653

EudraCT Number:

2015-000081-63

EU CT Number:

Not Available
A study to compare the effect of Transipeg 2.95 g or Forlax Junior 4 g in children with constipation

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

6 - 15 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
97
Trial Dates
April 2006 - December 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
Transipeg (Macrogol, BAY81-8430)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
EINDHOVEN, 5623 EJ, Netherlands
Completed
WOERDEN, 3447 GN, Netherlands
Completed
VELDHOVEN, 5504 DB, Netherlands

Primary Outcome

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

Secondary Outcome

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

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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