MedDataX Logo

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

NCT ID: NCT00793247

Last Updated: 2008-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Intestinal Pseudo-Obstruction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRU-PLA-PRU-PLA

Intervention Type DRUG

PLA-PRU-PLA-PRU

Intervention Type DRUG

PLA-PRU-PRU-PLA

Intervention Type DRUG

PRU-PLA-PLA-PRU

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Movetis

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwick Park Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GBR-7

Identifier Type: -

Identifier Source: org_study_id