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

NCT00793247 | Completed Phase 2

• 1 other identifier: GBR-7
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Intestinal Pseudo-Obstruction

Interventions

PRU-PLA-PRU-PLA DRUG

PLA-PRU-PLA-PRU DRUG

PLA-PRU-PRU-PLA DRUG

PRU-PLA-PLA-PRU DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Movetis: lead

Study Sites (1)

Northwick Park Hospital

London, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Last Updated: November 19, 2008

Record last verified: 2008-11

Locations

GB (1)