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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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