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

Chronic Intestinal Pseudo-Obstruction 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793247
• Other study ID #: GBR-7
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2008
• Last updated: November 18, 2008

Study information

• Verified date: November 2008
• Source: Movetis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Intestinal Pseudo-Obstruction
• Intestinal Pseudo-Obstruction

Intervention

Drug:
• PRU-PLA-PRU-PLA

• PLA-PRU-PLA-PRU

• PLA-PRU-PRU-PLA

• PRU-PLA-PLA-PRU

Locations

Country	Name	City	State
United Kingdom	Northwick Park Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Movetis

Country where clinical trial is conducted

United Kingdom,