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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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).

Conditions
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Chronic Intestinal Pseudo-Obstruction

Intervention / Treatment
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* Drug: PRU-PLA-PRU-PLA
* Drug: PLA-PRU-PLA-PRU
* Drug: PLA-PRU-PRU-PLA
* Drug: PRU-PLA-PLA-PRU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PRU-PLA-PRU-PLA|nan|
|Drug: PLA-PRU-PLA-PRU|nan|
|Drug: PLA-PRU-PRU-PLA|nan|
|Drug: PRU-PLA-PLA-PRU|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |