check_circleStudy Completed
Constipation
Bayer Identifier:
12052
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
6 - 15 YearsTrial summary
Enrollment Goal
97Trial Dates
April 2006 - December 2008Phase
Phase 4Could I Receive a placebo
NoProducts
Transipeg (Macrogol, BAY81-8430)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 Weeksdate_rangeTime Frame:Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
- Change From Baseline in Total Sum Score (TSS) at Week 52date_rangeTime Frame:Baseline, Week 52
- Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baselinedate_rangeTime Frame:Average of Weeks 1 to 8
- Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baselinedate_rangeTime Frame:Average of Weeks 26 and 52
- Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baselinedate_rangeTime Frame:Average up to 52 weeks
- Dose Range Determination: Mean Dose Based on Sachets Useddate_rangeTime Frame:Up to 52 weeks.
- Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Useddate_rangeTime Frame:Up to 52 weeks
Secondary Outcome
- Percentage of Treatment Successdate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Defecation Frequencydate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Consistency of the Fecesdate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Strains During Defecationdate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Quantity of Stoolsdate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects With Pain During Defecationdate_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 Paindate_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 Defecationdate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Nightdate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time pointsdate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects With Urgency for Defecationdate_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 Nightdate_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 Appetitedate_rangeTime Frame:Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Average Score for Diary Reported Diarrhoeadate_rangeTime Frame:Week 0, 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Average Score for Diary Reported Flatulencedate_rangeTime Frame:Week 0, 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Average Score for Diary Reported Nauseadate_rangeTime Frame:Week 0, 1, 2, 4, 8, 12, 26, 52
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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