Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm (NCT02260154) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
Russia220 participantsStarted 2015-07
Plain-language summary
Prospective, multicenter, non-comparative, observational program designed to assess the effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID) and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms
Who can participate
Age range
18 Years – 65 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:
* Male or female ≥ 18 years to 65 years;
* Patients suffering from post-cholecystectomy GI-spasms in the last 3 months with symptom onset at least 6 months prior to inclusion and not requiring surgical treatment;
* Laparoscopic cholecystectomy between 6 months to 5 years before enrollment;
* Patients having been prescribed Duspatalin® (mebeverine) 200 mg BID (bis in die = twice a day) in accordance with approved local label;
* Patient's written authorization to provide data for the program
Exclusion Criteria:
* General and specific contraindications to Duspatalin® treatment according to the local label;
* Planned Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or surgical treatment;
* Being currently treated or having been treated with Duspatalin® within the 6 weeks prior to entering the program;
* Pregnancy or lactation;
* Other conditions that make patient participation impossible (by investigator judgment);
* Previous enrollment in the present program;
* Treatment with other antispasmodics, pain-medication (Nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, etc.) within 2 weeks prior to inclusion into the observational study.
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.