Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP) (NCT00793247) | Clinical Trial Compass
CompletedPhase 2
Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)
United Kingdom
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.