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Completed

NCT Number: NCT02260154

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

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

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Key information

Conditions

Post-cholecystectomy Gastrointestinal Spasms Abdominal Pain Dyspepsia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Facility ID ORG-001035, Chita, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mebeverine

Drug

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

Primary outcomes

  1. Percentage of "Responders" to Duspatalin® Therapy

    Time frame: 2 weeks

    Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment

Secondary outcomes

  1. Percentage of "Responders" to Duspatalin® Therapy

    Time frame: Up to 6 weeks

  2. 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.

  3. 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.

  4. 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'.

  5. 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.

  6. Health Economic Data

    Time frame: Baseline, up to 6 weeks

    Relevant concomitant medication

  7. Reasons for Continuing Treatment Beyond 2 Weeks

    Time frame: 2 weeks

    List and rate of reasons

  8. 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.

  9. 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.

  10. 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'.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Acronym: ODYSSEY

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2014
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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