Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)

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

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