Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborator: Data Matrix
• Treatments: Alverine; Mebeverine

Criteria

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.