Status:
COMPLETED
Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)
Lead Sponsor:
Movetis
Conditions:
Chronic Intestinal Pseudo-Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years;
- A history of chronic pseudo-obstruction for at least 3 months;
- Subjects with chronic idiopathic pseudo-obstruction or chronic pseudo-obstruction secondary to scleroderma or intestinal polyneuropathy;
- CIP had been diagnosed by a Barium-imaging study showing the presence of dilatation of any part of the small bowel (with or without the presence of large bowel dilatation);
Exclusion
- Subjects with organic obstructing lesions causing intestinal obstruction;
- Current uncontrolled cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abuse but with the exception of nicotin), alcoholism, cancer or AIDS and endocrine disorder;
- Impaired renal function
- A serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT) or a serum glutamic-pyruvic transaminase (SGPT)concentration of \> 2 times the normal limit;
- Laboratory values outside the reference range of the laboratory, unless explained by the disease or felt by the investigator to be clinically unimportant;
- Use of disallowed concomitant therapy;
- Female subjects who were pregnant or wished to become pregnant during the course of the trial or who were lactating;
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00793247
Last Update
November 19 2008
Active Locations (1)
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1
Northwick Park Hospital
London, United Kingdom