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

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00793247
First received: November 18, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Intestinal Pseudo-Obstruction
Drug: PRU-PLA-PRU-PLA
Drug: PLA-PRU-PLA-PRU
Drug: PLA-PRU-PRU-PLA
Drug: PRU-PLA-PLA-PRU
Phase 2

Study Type: Interventional
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).

Resource links provided by NLM:


Further study details as provided by Movetis:

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793247

Locations
United Kingdom
Northwick Park Hospital
London, United Kingdom
Sponsors and Collaborators
Movetis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00793247     History of Changes
Other Study ID Numbers: GBR-7
Study First Received: November 18, 2008
Last Updated: November 18, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Intestinal Pseudo-Obstruction
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014