Skip to main content
OpenTrials
Completed

NCT Number: NCT01810653

A Study to Compare the Effect of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macrogol (Transipeg, BAY81-8430)

Drug

Up to 4 sachets per day based on individual titration

Macrogol (Forlax)

Drug

Up to 4 sachets per day based on individual titration

Primary outcomes

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

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

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

    Time frame: Baseline, Week 52

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

    Time frame: Average of Weeks 1 to 8

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

    Time frame: Average of Weeks 26 and 52

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

    Time frame: Average up to 52 weeks

  6. Dose Range Determination: Mean Dose Based on Sachets Used

    Time frame: Up to 52 weeks.

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

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Percentage of Treatment Success

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  2. Individual Symptoms: Defecation Frequency

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  3. Individual Symptoms: Consistency of the Feces

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  4. Individual Symptoms: Strains During Defecation

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  5. Individual Symptoms: Quantity of Stools

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  6. Individual Symptoms: Percentage of Subjects With Pain During Defecation

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  7. Individual Symptoms: Frequency of Pain (Times per Week)

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  8. Percentage of Subjects With Abdominal Pain

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

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

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  10. Individual Symptoms: Relation of Abdominal Pain With Defecation

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  11. 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

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

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  13. Individual Symptoms: Percentage of Subjects With Urgency for Defecation

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

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

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

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

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

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

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

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

    Time frame: Week 1, 2, 4, 8, 12, 26, 52

  18. Individual Symptoms: Average Score for Diary Reported Diarrhoea

    Time frame: Week 0, 1, 2, 4, 8, 12, 26, 52

  19. Individual Symptoms: Average Score for Diary Reported Flatulence

    Time frame: Week 0, 1, 2, 4, 8, 12, 26, 52

  20. Individual Symptoms: Average Score for Diary Reported Nausea

    Time frame: Week 0, 1, 2, 4, 8, 12, 26, 52

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2013
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.