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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00793247
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : November 19, 2008
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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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00793247

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United Kingdom
Northwick Park Hospital
London, United Kingdom
Sponsors and Collaborators
Layout table for additonal information Identifier: NCT00793247    
Other Study ID Numbers: GBR-7
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Intestinal Pseudo-Obstruction
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases