Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00793247|
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : November 19, 2008
|Condition or disease||Intervention/treatment||Phase|
|Chronic Intestinal Pseudo-Obstruction||Drug: PRU-PLA-PRU-PLA Drug: PLA-PRU-PLA-PRU Drug: PLA-PRU-PRU-PLA Drug: PRU-PLA-PLA-PRU||Phase 2|
This phase II, double-blind, placebo-controlled, two-treatment four periods cross-over trial investigated the clinical safety, tolerability and the efficacy of R093877 (prucalopride) in improving the symptoms associated with chronic intestinal pseudo-obstruction (CIP) in subjects with CIP.
Subjects were treated for 4 periods of 12 weeks each with either R093877 2 mg (2 periods) or placebo (2 periods). In each of the first and second 6 month period, there was a placebo (PLA) and an active drug (PRU) treatment period. There were no wash-out periods. In total,7 subjects were randomized; 2 were assigned to the PLA-PRU-PLA-PRU, 2 to the PRUPLA-PRU-PLA, 2 to the PLA-PRU-PRU-PLA, and 1 to the PRU-PLA-PLA-PRU sequence group. Subjects were allowed to use up to 4 mg of prucalopride per day if the 2 mg dose seemed to be insufficient. Two subjects used an average of 3 mg of prucalopride per day during the active drug periods.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Double-Blind, Placebo-Controlled, Cross-Over, Multiple (n=1) Trial to Evaluate the Effects of R093877 in Patients With Chronic Intestinal Pseudo-Obstruction (CIP).|
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): NCT00793247
|Northwick Park Hospital|
|London, United Kingdom|