Clinical trial NCT02260154: Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-cholecystectomy Gastrointestinal Spasms
Keywords: Duspatalin
mebeverine
cholecystectomy
gastrointestinal spasm
abdominal pain
dyspepsia
antispasmodics
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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


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.

Primary outcomes:
measure: Percentage of "Responders" to Duspatalin® Therapy
timeFrame: 2 weeks
Secondary outcomes:
measure: Percentage of "Responders" to Duspatalin® Therapy
timeFrame: Up to 6 weeks
measure: Changes in Abdominal Pain
timeFrame: Baseline, 2 weeks and up to 6 weeks
measure: Changes in Dyspepsia Symptoms
timeFrame: Baseline, 2 weeks and up to 6 weeks
measure: Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form
timeFrame: Baseline to Week 2
measure: Changes in Quality of Life
timeFrame: Baseline, 2 weeks and up to 6 weeks
measure: Health Economic Data
timeFrame: Baseline, up to 6 weeks
measure: Reasons for Continuing Treatment Beyond 2 Weeks
timeFrame: 2 weeks
measure: Healths Economic Data 2
timeFrame: from baseline at Week 6
measure: Health Economics Data 3
timeFrame: change from baseline at Week 6
measure: Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Chita
country: Russian Federation
facility: Research Facility ID ORG-001035
city: Irkutsk
country: Russian Federation
facility: State Budget Institution " Irkutsk State Medical Academy of postgraduate education"
city: Izhevsk
country: Russian Federation
facility: Research Facility ID ORG-001038
city: Kazan
country: Russian Federation
facility: Research Facility ID ORG-001033
city: Khabarovsk
country: Russian Federation
facility: Non-governmental Healthcare Institution "Road Clinical Hospital on the station Khabarovsk-1 OSS "Russian Railways"
city: Krasnoyarsk
country: Russian Federation
facility: Research Facility ID ORG-001034
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-001039
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "Outpatient hospital №1" Administration of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: 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"
city: Moscow
country: Russian Federation
facility: State Budget Institution "Russian Medical Academy of Postgraduate Studies
city: Moscow
country: Russian Federation
facility: State Budget Institution of Health Care of Moscow region " MF Vladimirsky Moscow Region Scientific Research Clinical University"
city: Moscow
country: Russian Federation
facility: Research Facility ID ORG-001024
city: Nizhny Novgorod
country: Russian Federation
facility: State Budget Institution "Nizhny Novgorod Regional Clinical Hospital n.a. Semashko"
city: Novosibirsk
country: Russian Federation
facility: State Budget Institution "Novosibirsk State Medical University"
city: Omsk
country: Russian Federation
facility: Research Facility ID ORG-000903
city: Pushino
country: Russian Federation
facility: Federal State Budget Institution Hospital of the Pushchino Scientific Center of the Russian Academy of Sciences
city: Rostov-on-Don
country: Russian Federation
facility: Research Facility ID ORG-001036
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budget Institution All-Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
city: Saint Petersburg
country: Russian Federation
facility: State Budget Institution "North-Western State Medical University named after I.I. Mechnikov", on the base of State Budget Institution "Sity Clinical Hospital #26"
city: Saransk
country: Russian Federation
facility: Research Facility ID ORG-001037
city: Yekaterinburg
country: Russian Federation
facility: City Clinical Hospital #40
Study officials:
affiliation: Abbott
name: Tatiana Vladimirova, MD, PhD
role: STUDY_DIRECTOR
References: