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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00793247
• Date of registration: 18/11/2008
• Prospective Registration: Yes
• Primary sponsor: Movetis
• Public title: Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)
• Scientific 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).
• Date of first enrolment: December 2008
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00793247
• Study type: Interventional
• Study design: N/A
• Phase: Phase 2

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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;



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Intestinal Pseudo-Obstruction

Intervention(s)

Drug: PRU-PLA-PLA-PRU

Drug: PRU-PLA-PRU-PLA

Drug: PLA-PRU-PRU-PLA

Drug: PLA-PRU-PLA-PRU

Secondary ID(s)

GBR-7

Source(s) of Monetary Support

Please refer to primary and secondary sponsors