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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2008
Source Movetis
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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;

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
PRU-PLA-PRU-PLA

PLA-PRU-PLA-PRU

PLA-PRU-PRU-PLA

PRU-PLA-PLA-PRU


Locations

Country Name City State
United Kingdom Northwick Park Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Movetis

Country where clinical trial is conducted

United Kingdom, 

See also
  Status Clinical Trial Phase
Recruiting NCT04506593 - Indiana University Gastrointestinal Motility Diagnosis Registry
Recruiting NCT04193735 - Pseudo-obstruction Assessment With MRI
Active, not recruiting NCT04118699 - Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial Phase 2
Active, not recruiting NCT05724069 - Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). Phase 2