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

Study Overview
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Brief Summary
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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

Official Title
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Effectiveness of Duspatalin® (Mebeverine Hydrochloride) 200 mg b.i.d. in Patients With Post-cholecystectomy Gastrointestinal Spasm: a Post Marketing Observational Program in the Russian Federation

Conditions
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Post-cholecystectomy Gastrointestinal Spasms

Intervention / Treatment
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* Drug: Mebeverine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-cholecystectomy gastrointestinal spasms<br>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Drug: Mebeverine<br>* Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed<br>* Other names: Duspatalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders to Duspatalin® Therapy | Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders to Duspatalin® Therapy |  | Up to 6 weeks | 
| Changes in Abdominal Pain | Measured by 11-items Numerous Rating Scale where 0 represents no pain and 10 represents the worst pain. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value. | Baseline, 2 weeks and up to 6 weeks | 
| Changes in Dyspepsia Symptoms | Measured by 11-items Numerous Rating Scale where 0 represents no symptoms and 10 represents the worst symptoms. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value. | Baseline, 2 weeks and up to 6 weeks | 
| Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form | Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. Positive is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 2'. Negative is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'. | Baseline to Week 2 | 
| Changes in Quality of Life | Gastrointestinal Quality of Life Index contains 36 questions with 4 possible answers per each (most desirable option returns 4 points, and least desirable option returns 0 points). Total score of the GIQLI is calculated as sum of all items. The source scores are transformed and scaled from 0 to 100. The high score corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value. | Baseline, 2 weeks and up to 6 weeks | 
| Health Economic Data | Relevant concomitant medication | Baseline, up to 6 weeks | 
| Reasons for Continuing Treatment Beyond 2 Weeks | List and rate of reasons | 2 weeks | 
| Healths Economic Data 2 | Number of visits to clinic for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of visits to clinic. | from baseline at Week 6 | 
| Health Economics Data 3 | Number of days missed from work for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of days missed from work. | change from baseline at Week 6 | 
| Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2 | Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. Positive is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 6'. Negative is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 6'. | Baseline to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duspatalin, mebeverine, cholecystectomy, gastrointestinal spasm, abdominal pain, dyspepsia, antispasmodics