Clinical trial NCT01810653: A Study to Compare the Effect of Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: Macrogol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 97
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks
timeFrame: Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
measure: Change From Baseline in Total Sum Score (TSS) at Week 52
timeFrame: Baseline, Week 52
measure: Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline
timeFrame: Average of Weeks 1 to 8
measure: Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline
timeFrame: Average of Weeks 26 and 52
measure: Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline
timeFrame: Average up to 52 weeks
measure: Dose Range Determination: Mean Dose Based on Sachets Used
timeFrame: Up to 52 weeks.
measure: Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Percentage of Treatment Success
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Defecation Frequency
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Consistency of the Feces
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Strains During Defecation
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Quantity of Stools
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Percentage of Subjects With Pain During Defecation
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Frequency of Pain (Times per Week)
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Percentage of Subjects With Abdominal Pain
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Frequency of Abdominal Pain (Times per Week)
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Relation of Abdominal Pain With Defecation
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Percentage of Subjects With Urgency for Defecation
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite
timeFrame: Week 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Average Score for Diary Reported Diarrhoea
timeFrame: Week 0, 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Average Score for Diary Reported Flatulence
timeFrame: Week 0, 1, 2, 4, 8, 12, 26, 52
measure: Individual Symptoms: Average Score for Diary Reported Nausea
timeFrame: Week 0, 1, 2, 4, 8, 12, 26, 52
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
city: Eindhoven
country: Netherlands
city: Veldhoven
country: Netherlands
city: Woerden
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.