Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
- Registration Number
- NCT02260154
- Lead Sponsor
- Abbott
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post-cholecystectomy gastrointestinal spasms Mebeverine Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
- Primary Outcome Measures
Name Time Method Percentage of "Responders" to Duspatalin® Therapy 2 weeks Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
- Secondary Outcome Measures
Name Time Method Percentage of "Responders" to Duspatalin® Therapy Up to 6 weeks Changes in Dyspepsia Symptoms Baseline, 2 weeks and up to 6 weeks 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.
Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form Baseline to Week 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 2'. "Negative" is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'.
Changes in Quality of Life Baseline, 2 weeks and up to 6 weeks 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.
Health Economic Data Baseline, up to 6 weeks Relevant concomitant medication
Reasons for Continuing Treatment Beyond 2 Weeks 2 weeks List and rate of reasons
Healths Economic Data 2 from baseline at Week 6 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.
Health Economics Data 3 change from baseline at Week 6 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.
Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2 Baseline to Week 6 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'.
Changes in Abdominal Pain Baseline, 2 weeks and up to 6 weeks 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.
Trial Locations
- Locations (21)
Research Facility ID ORG-001038
🇷🇺Izhevsk, Russian Federation
State Budget Institution " Irkutsk State Medical Academy of postgraduate education"
🇷🇺Irkutsk, Russian Federation
Research Facility ID ORG-001035
🇷🇺Chita, Russian Federation
Federal State Budget Institution Hospital of the Pushchino Scientific Center of the Russian Academy of Sciences
🇷🇺Pushino, Russian Federation
State Budget Institution "Pirogov Russian National Research Medical University", on the base of State Budget Institution of Health Care of Moscow "City Clinical Hospital №31"
🇷🇺Moscow, Russian Federation
Research Facility ID ORG-001036
🇷🇺Rostov-on-Don, Russian Federation
State Budget Institution "Russian Medical Academy of Postgraduate Studies
🇷🇺Moscow, Russian Federation
Research Facility ID ORG-000903
🇷🇺Omsk, Russian Federation
Research Facility ID ORG-001033
🇷🇺Kazan, Russian Federation
Research Facility ID ORG-001024
🇷🇺Moscow, Russian Federation
Research facility ID ORG-001039
🇷🇺Moscow, Russian Federation
State Budget Institution of Health Care of Moscow region " MF Vladimirsky Moscow Region Scientific Research Clinical University"
🇷🇺Moscow, Russian Federation
Non-governmental Healthcare Institution "Road Clinical Hospital on the station Khabarovsk-1 OSS "Russian Railways"
🇷🇺Khabarovsk, Russian Federation
Research Facility ID ORG-001034
🇷🇺Krasnoyarsk, Russian Federation
State Budget Institution "Nizhny Novgorod Regional Clinical Hospital n.a. Semashko"
🇷🇺Nizhny Novgorod, Russian Federation
State Budget Institution "Novosibirsk State Medical University"
🇷🇺Novosibirsk, Russian Federation
Federal State Budget Institution All-Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
🇷🇺Saint Petersburg, Russian Federation
City Clinical Hospital #40
🇷🇺Yekaterinburg, Russian Federation
Research Facility ID ORG-001037
🇷🇺Saransk, Russian Federation
State Budget Institution "North-Western State Medical University named after I.I. Mechnikov", on the base of State Budget Institution "Sity Clinical Hospital #26"
🇷🇺Saint Petersburg, Russian Federation
Federal State Budget Institution "Outpatient hospital №1" Administration of the President of the Russian Federation
🇷🇺Moscow, Russian Federation