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

Abbott

Status: Completed

Conditions: Post-cholecystectomy Gastrointestinal Spasms

Treatments: Drug: Mebeverine

Study type: Observational

Funder types: Industry

Identifiers

NCT02260154

MEBE5002

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

220 participants in 1 patient group

Post-cholecystectomy gastrointestinal spasms

Description:

Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day

Treatment:

Drug: Mebeverine