Effectiveness of DuspatalinĀ® in Patients With Post-cholecystectomy Gastrointestinal Spasm (NCT02260154) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of DuspatalinĀ® 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 DuspatalinĀ® 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 range18 Years ā 65 Years
SexALL
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 ā„ 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 DuspatalinĀ® (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 DuspatalinĀ® treatment according to the local label;
* Planned Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or surgical treatment;
* Being currently treated or having been treated with DuspatalinĀ® 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.
What they're measuring
1
Percentage of "Responders" to DuspatalinĀ® Therapy