Back to resultsEfficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)
Primary Purpose
Chronic Intestinal Pseudo-Obstruction
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
PRU-PLA-PRU-PLA
PLA-PRU-PLA-PRU
PLA-PRU-PRU-PLA
PRU-PLA-PLA-PRU
Sponsored by
About this trial
This is an interventional trial for Chronic Intestinal Pseudo-Obstruction
Eligibility 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;
Sites / Locations
- Northwick Park Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00793247
Brief Title
Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)
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).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Movetis
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Intestinal Pseudo-Obstruction
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PRU-PLA-PRU-PLA
Intervention Type
Drug
Intervention Name(s)
PLA-PRU-PLA-PRU
Intervention Type
Drug
Intervention Name(s)
PLA-PRU-PRU-PLA
Intervention Type
Drug
Intervention Name(s)
PRU-PLA-PLA-PRU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
Northwick Park Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)
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