Chronic Intestinal Pseudo-Obstruction 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).
NCT number | NCT00793247 |
Other study ID # | GBR-7 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | November 18, 2008 |
Last updated | November 18, 2008 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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; |
N/A
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northwick Park Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Movetis |
United Kingdom,
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