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Clinical Trial Summary

This study was designed to investigate the clinical safety, tolerability and efficacy of prucalopride in improving the symptoms associated with chronic intestinal pseudo-obstruction (CIP) in subjects with CIP. The study hypothesis was that prucalopride at doses up to 4 mg is safe, well tolerated, efficacious and improves the symptoms associated with CIP.


Clinical Trial Description

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 Design

N/A


Related Conditions & MeSH terms


NCT number NCT00793247
Study type Interventional
Source Movetis
Contact
Status Completed
Phase Phase 2

See also
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Active, not recruiting NCT04118699 - Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial Phase 2
Active, not recruiting NCT05724069 - Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). Phase 2