Efficacy and Safety Study of Prucalopride for the Re-Treatment of Chronic Constipation
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|ClinicalTrials.gov Identifier: NCT00598338|
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : May 29, 2008
The purpose of this study is to determine whether prucalopride is safe and effective in the re-treatment of chronic constipation.
Retreatment is as effective and safe as treatment with prucalopride in patients with chronic constipation.
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: Prucalopride Other: Placebo||Phase 3|
This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 4-week double-blind, placebo-controlled treatment period, a drug-free washout period of at least 2 weeks, and a second 4-week double-blind treatment period.
During the initial run-in period, the subject's bowel habit will be documented in a daily diary and the existence of constipation will be confirmed. Eligible subjects will be randomly allocated to double-blind treatment with either 4 mg prucalopride or placebo, given orally once daily before breakfast, for 4 weeks.
After 4 weeks of treatment, each subject will enter a drug-free washout period. The length of the washout period will be either 2 or 4 weeks, depending on how long it takes for the subject to meet the criteria for constipation. If the subject is unable to re-qualify after a 4-week washout, the subject must be discontinued from the trial.
Subjects who qualify for the second double-blind treatment period will receive the same treatment as during the first treatment period, once-daily for an additional four weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||516 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Two-Period, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of re-Treatment of Prucalopride on Efficacy and Safety in Subjects With Chronic Constipation.|
|Study Start Date :||April 1999|
|Actual Primary Completion Date :||February 2000|
|Actual Study Completion Date :||February 2000|
Active Comparator: 1
4 mg o.d.
Other Name: Resolor
Placebo Comparator: 2
- Proportion (%) of subjects with three or more spontaneous, complete bowel movements per week. [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598338
|Principal Investigator:||Miner, Jr. B Miner, MD||Oklahoma Foundation for Digestive Research|