Status:
COMPLETED
Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
Lead Sponsor:
Abbott
Conditions:
Post-cholecystectomy Gastrointestinal Spasms
Eligibility:
All Genders
18-65 years
Brief 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 qual...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT02260154
Start Date
July 1 2015
End Date
October 1 2016
Last Update
June 6 2019
Active Locations (21)
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1
Research Facility ID ORG-001035
Chita, Russia, 672090
2
State Budget Institution " Irkutsk State Medical Academy of postgraduate education"
Irkutsk, Russia, 664049
3
Research Facility ID ORG-001038
Izhevsk, Russia, 426034
4
Research Facility ID ORG-001033
Kazan', Russia, 420029