N/A
N=220
Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
Post-cholecystectomy Gastrointestinal Spasms
Bottom Line
View on ClinicalTrials.gov: NCT02260154 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of "Responders" to Duspatalin® Therapy — 63.6; 36.4 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Mebeverine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of "Responders" to Duspatalin® Therapy |
79.0 | — |
| SECONDARY Percentage of "Responders" to Duspatalin® Therapy |
79.0 | — |
| SECONDARY Changes in Abdominal Pain |
-3.7; -4.4 | — |
| SECONDARY Changes in Dyspepsia Symptoms |
-2.0; -2.3 | — |
| SECONDARY Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form |
38.25; 2.30 | — |
| SECONDARY Changes in Quality of Life |
16.802; 21.737 | — |
| SECONDARY Health Economic Data |
9.6; 0.5; 2.3; 1.4; 0.5; 1.4 | — |
| SECONDARY Reasons for Continuing Treatment Beyond 2 Weeks |
84.2; 4.0; 11.9 | — |
| SECONDARY Healths Economic Data 2 |
-0.9 | — |
| SECONDARY Health Economics Data 3 |
-2.1 | — |
| SECONDARY Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2 |
40.00; 2.00 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02260154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.