Post-cholecystectomy Gastrointestinal Spasms Clinical Trial
— ODYSSEYOfficial title:
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
| NCT number | NCT02260154 |
| Other study ID # | MEBE5002 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | October 2016 |
| Verified date | March 2019 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Research Facility ID ORG-001035 | Chita | |
| Russian Federation | State Budget Institution " Irkutsk State Medical Academy of postgraduate education" | Irkutsk | |
| Russian Federation | Research Facility ID ORG-001038 | Izhevsk | |
| Russian Federation | Research Facility ID ORG-001033 | Kazan | |
| 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 | Federal State Budget Institution "Outpatient hospital ?1" Administration of the President of the Russian Federation | Moscow | |
| Russian Federation | Research Facility ID ORG-001024 | Moscow | |
| Russian Federation | Research facility ID ORG-001039 | Moscow | |
| 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 | State Budget Institution "Russian Medical Academy of Postgraduate Studies | Moscow | |
| Russian Federation | State Budget Institution of Health Care of Moscow region " MF Vladimirsky Moscow Region Scientific Research Clinical University" | Moscow | |
| 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 | Research Facility ID ORG-000903 | Omsk | |
| Russian Federation | Federal State Budget Institution Hospital of the Pushchino Scientific Center of the Russian Academy of Sciences | Pushino | |
| Russian Federation | Research Facility ID ORG-001036 | Rostov-on-Don | |
| Russian Federation | Federal State Budget Institution All-Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia | Saint Petersburg | |
| 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 | Research Facility ID ORG-001037 | Saransk | |
| Russian Federation | City Clinical Hospital #40 | Yekaterinburg |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of "Responders" to Duspatalin® Therapy | Patients indicating being `symptom-free` or `markedly improved`on Global Patient Assessment | 2 weeks | |
| Secondary | Percentage of "Responders" to Duspatalin® Therapy | Up to 6 weeks | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Health Economic Data | Relevant concomitant medication | Baseline, up to 6 weeks | |
| Secondary | Reasons for Continuing Treatment Beyond 2 Weeks | List and rate of reasons | 2 weeks | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |