Trial Condition(s):
Constipation
A study to compare the effect of Transipeg 2.95 g or Forlax Junior 4 g in children with constipation
Bayer Identifier:
12052
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EINDHOVEN, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site WOERDEN, Netherlands, 3447 GN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VELDHOVEN, Netherlands, 5504 DB | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Symptom Based Weekly Total Sum Score (TSS) Over 52 WeeksTimeframe: Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
- Change From Baseline in Total Sum Score (TSS) at Week 52Timeframe: Baseline, Week 52
- Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus BaselineTimeframe: Average of Weeks 1 to 8
- Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus BaselineTimeframe: Average of Weeks 26 and 52
- Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus BaselineTimeframe: Average up to 52 weeks
- Dose Range Determination: Mean Dose Based on Sachets UsedTimeframe: Up to 52 weeks.
- Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets UsedTimeframe: Up to 52 weeks
Secondary Outcome
- Percentage of Treatment SuccessTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Defecation FrequencyTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Consistency of the FecesTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Strains During DefecationTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Quantity of StoolsTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects With Pain During DefecationTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Frequency of Pain (Times per Week)Timeframe: Week 1, 2, 4, 8, 12, 26, 52
- Percentage of Subjects With Abdominal PainTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Frequency of Abdominal Pain (Times per Week)Timeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Relation of Abdominal Pain With DefecationTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at NightTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time pointsTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects With Urgency for DefecationTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)Timeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and NightTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)Timeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad AppetiteTimeframe: Week 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Average Score for Diary Reported DiarrhoeaTimeframe: Week 0, 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Average Score for Diary Reported FlatulenceTimeframe: Week 0, 1, 2, 4, 8, 12, 26, 52
- Individual Symptoms: Average Score for Diary Reported NauseaTimeframe: Week 0, 1, 2, 4, 8, 12, 26, 52
Additional Information
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