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
2 other identifiers
interventional
97
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2006
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedAugust 13, 2015
August 1, 2015
2.7 years
March 12, 2013
August 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (20)
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
- +15 more secondary outcomes
Study Arms (2)
Macrogol (Transipeg)
EXPERIMENTALMacrogol (Forlax)
ACTIVE COMPARATORInterventions
Up to 4 sachets per day based on individual titration
Eligibility Criteria
You may qualify if:
- Childhood functional constipation
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (4)
Unknown Facility
Amsterdam, 1105 AZ, Netherlands
Unknown Facility
Eindhoven, 5623 EJ, Netherlands
Unknown Facility
Veldhoven, 5504 DB, Netherlands
Unknown Facility
Woerden, 3447 GN, Netherlands
Related Publications (1)
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.
PMID: 28906317DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 13, 2013
Study Start
April 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 13, 2015
Record last verified: 2015-08