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

March 1, 2019 updated by: Abbott

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chita, Russian Federation, 672090
        • Research Facility ID ORG-001035
      • Irkutsk, Russian Federation, 664049
        • State Budget Institution " Irkutsk State Medical Academy of postgraduate education"
      • Izhevsk, Russian Federation, 426034
        • Research Facility ID ORG-001038
      • Kazan, Russian Federation, 420029
        • Research Facility ID ORG-001033
      • Khabarovsk, Russian Federation, 680022
        • Non-governmental Healthcare Institution "Road Clinical Hospital on the station Khabarovsk-1 OSS "Russian Railways"
      • Krasnoyarsk, Russian Federation, 660020
        • Research Facility ID ORG-001034
      • Moscow, Russian Federation, 111123
        • Research facility ID ORG-001039
      • Moscow, Russian Federation, 119002
        • Federal State Budget Institution "Outpatient hospital №1" Administration of the President of the Russian Federation
      • Moscow, Russian Federation, 119415
        • 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, 123836
        • State Budget Institution "Russian Medical Academy of Postgraduate Studies
      • Moscow, Russian Federation, 129110
        • State Budget Institution of Health Care of Moscow region " MF Vladimirsky Moscow Region Scientific Research Clinical University"
      • Moscow, Russian Federation, 129128
        • Research Facility ID ORG-001024
      • Nizhny Novgorod, Russian Federation, 603126
        • State Budget Institution "Nizhny Novgorod Regional Clinical Hospital n.a. Semashko"
      • Novosibirsk, Russian Federation
        • State Budget Institution "Novosibirsk State Medical University"
      • Omsk, Russian Federation, 644043
        • Research Facility ID ORG-000903
      • Pushino, Russian Federation
        • Federal State Budget Institution Hospital of the Pushchino Scientific Center of the Russian Academy of Sciences
      • Rostov-on-Don, Russian Federation, 344022
        • Research Facility ID ORG-001036
      • Saint Petersburg, Russian Federation, 194044
        • Federal State Budget Institution All-Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
      • Saint Petersburg, Russian Federation, 196247
        • State Budget Institution "North-Western State Medical University named after I.I. Mechnikov", on the base of State Budget Institution "Sity Clinical Hospital #26"
      • Saransk, Russian Federation, 430005
        • Research Facility ID ORG-001037
      • Yekaterinburg, Russian Federation, , 620102
        • City Clinical Hospital #40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-cholecystectomy gastrointestinal spasms
Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
Drug: Mebeverine
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
Other Names:
  • Duspatalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of "Responders" to Duspatalin® Therapy
Time Frame: 2 weeks
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
Time Frame: Up to 6 weeks
Up to 6 weeks
Changes in Abdominal Pain
Time Frame: 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.
Baseline, 2 weeks and up to 6 weeks
Changes in Dyspepsia Symptoms
Time Frame: 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.
Baseline, 2 weeks and up to 6 weeks
Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form
Time Frame: 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'.
Baseline to Week 2
Changes in Quality of Life
Time Frame: 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.
Baseline, 2 weeks and up to 6 weeks
Health Economic Data
Time Frame: Baseline, up to 6 weeks
Relevant concomitant medication
Baseline, up to 6 weeks
Reasons for Continuing Treatment Beyond 2 Weeks
Time Frame: 2 weeks
List and rate of reasons
2 weeks
Healths Economic Data 2
Time Frame: 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.
from baseline at Week 6
Health Economics Data 3
Time Frame: 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.
change from baseline at Week 6
Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2
Time Frame: 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'.
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Tatiana Vladimirova, MD, PhD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEBE5002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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