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

Abbott220 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Post-cholecystectomy Gastrointestinal Spasms

Interventions

MebeverineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (21)

Outcomes

Primary Outcomes

Percentage of "Responders" to Duspatalin® Therapy

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

Time frame: 2 weeks

Secondary Outcomes

Percentage of "Responders" to Duspatalin® Therapy

Time frame: 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.

Time frame: 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.

Time frame: 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'.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.