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 ]

Patients indicating being `symptom-free` or `markedly improved`on Global Patient Assessment


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