Clinical Trial: Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Effectiveness of Duspatalin® (Mebeverine Hydrochloride) 200 mg b.i.d. in Patients With Post-cholecystectomy Gastrointestinal Spasm: a Post Marketing Observational Pro
Brief Summary: Prospective, multicenter, non-comparative, observational program designed to assess the effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg BID and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms
Detailed Summary:
Sponsor: Abbott
Current Primary Outcome: Percentage of "responders" to Duspatalin® therapy [ Time Frame: 2 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of "responders" to Duspatalin® therapy [ Time Frame: Up to 6 weeks ]
- Changes in abdominal pain [ Time Frame: Baseline, 2 weeks and up to 6 weeks ]Measured by 11-point numerical rating scale and patient`s assessment
- Changes in dyspepsia symptoms [ Time Frame: Baseline, 2 weeks and up to 6 weeks ]Measured by 11-point numerical rating scale and patient`s assessment
- Changes in stool habits and percentage of patients with abnormal stool form [ Time Frame: Baseline, 2 weeks and up to 6 weeks ]Stool form is measured by Bristol Stool Form scale
- Changes in quality of life [ Time Frame: Baseline, 2 weeks and up to 6 weeks ]Gastrointestinal Quality of Life Index
- Subjects characteristics [ Time Frame: Baseline ]Demographics data, relevant medical history and available laboratory data
- Health economic data [ Time Frame: Baseline, up to 6 weeks ]Relevant concomitant medication, number of visits to clinic and days missed from work for currently employed subjects
- Reasons for continuing treatment beyond 2 weeks [ Time Frame: 2 weeks ]List and rate of reasons
Original Secondary Outcome: Same as current
Information By: Abbott
Dates:
Date Received: September 29, 2014
Date Started: July 2015
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017