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Sponsored by: |
Movetis |
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Information provided by: | Movetis |
ClinicalTrials.gov Identifier: | NCT00576511 |
The purpose of this study is to determine whether prucalopride is safe and effective in patients with severe chronic constipation.
Condition | Intervention | Phase |
---|---|---|
Chronic Constipation |
Drug: prucalopride Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Severe Chronic Constipation |
Enrollment: | 53 |
Study Start Date: | December 1994 |
Study Completion Date: | February 1996 |
Primary Completion Date: | February 1996 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Prucalopride
|
Drug: prucalopride
4 mg o.d.
|
2: Placebo Comparator |
Drug: placebo
Placebo o.d.
|
This is a phase II trial with a parallel-group design, consisting of a run-in phase (phase I), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 4 mg or placebo o.d. for a period of 4 weeks.
Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation determined. If the definition of constipation was not met during the 4 weeks of the run-in period, double-blind treatment will not be started.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 4 weeks with either 4 mg of R093877 or placebo given o.d. (two capsules of 2 mg are taken before breakfast).
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients were eligible for inclusion if they were aged 18-75 years with a history of constipation, defined as the occurrence 2 of the following criteria during the previous 6 months or more:
All the patients screened for the study were dependent on osmotic laxatives (macrogol, milk of magnesia, lactulose), paraffin oil, glycerol or stimulant laxatives (antranoids, diphenylmethanes) given orally or rectally. The osmotic laxatives were taken on a daily base while the stimulant laxatives were restricted to 2, eventually 3 intakes per week. And although these laxatives, all or not combined promoted defaecation in the majority of patients, these regimens did not provide relief of constipation symptoms in none of the patients. Furthermore, many patients reported that the effect of the laxatives declined over time, that the intake of even stimulant laxatives was not consistently followed by rectal evacuation or that the intake of even stimulant laxatives was not consistently followed by rectal evacuation of that the dose and frequency of intake of laxatives had to be limited because of intolerable side effects including vomiting and abdominal cramps.
Eligible patients were also required to have constipation causing disability, with the patient's occupational, social and recreational activities governed by constipation and efforts to attain relief, and to have poor results with laxative treatment and diet counseling as determined by physician interview.
Patients also had to have a normal electromyographic inhibition pattern of the external anal sphincter during straining (assessed at the start of the treatment phase) and an absence of organic abnormalities of the colon (as assessed by barium enema or total colonoscopy).
Exclusion Criteria:
Responsible Party: | Movetis ( Renate Specht Gryp ) |
Study ID Numbers: | PRU-BEL-6 |
Study First Received: | December 17, 2007 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00576511 |
Health Authority: | Belgium: Institutional Review Board |
Constipation Prucalopride Colonic Transit Time |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |