Post-cholecystectomy Gastrointestinal SpasmsODYSSEYNCT02260154
Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
An observational study of Post-cholecystectomy Gastrointestinal Spasms, run by Abbott at 21 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-cholecystectomy Gastrointestinal Spasms
- What is being tested?
- Mebeverine
- How many people
- 220 participants
- Where
- 21 sitesRussia
- Study dates
- Jul 2015to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Russia21 sites
Research Facility ID ORG-001035
Chita, 672090
State Budget Institution " Irkutsk State Medical Academy of postgraduate education"
Irkutsk, 664049
Research Facility ID ORG-001038
Izhevsk, 426034
Research Facility ID ORG-001033
Kazan', 420029
Non-governmental Healthcare Institution "Road Clinical Hospital on the station Khabarovsk-1 OSS "Russian Railways"
Khabarovsk, 680022
Research Facility ID ORG-001034
Krasnoyarsk, 660020
Research facility ID ORG-001039
Moscow, 111123
Federal State Budget Institution "Outpatient hospital №1" Administration of the President of the Russian Federation
Moscow, 119002
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, 119415
State Budget Institution "Russian Medical Academy of Postgraduate Studies
Moscow, 123836
State Budget Institution of Health Care of Moscow region " MF Vladimirsky Moscow Region Scientific Research Clinical University"
Moscow, 129110
Research Facility ID ORG-001024
Moscow, 129128
State Budget Institution "Nizhny Novgorod Regional Clinical Hospital n.a. Semashko"
Nizhny Novgorod, 603126
State Budget Institution "Novosibirsk State Medical University"
Novosibirsk
Research Facility ID ORG-000903
Omsk, 644043
Federal State Budget Institution Hospital of the Pushchino Scientific Center of the Russian Academy of Sciences
Pushchino
Research Facility ID ORG-001036
Rostov-on-Don, 344022
Federal State Budget Institution All-Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
Saint Petersburg, 194044
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, 196247
Research Facility ID ORG-001037
Saransk, 430005
City Clinical Hospital #40
Yekaterinburg, , 620102
About this study
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
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
- Being tested
- Mebeverine
- Keywords
- Duspatalin, mebeverine, cholecystectomy, gastrointestinal spasm, abdominal pain, dyspepsia, antispasmodics
- Medical subject headings
- Abdominal Pain, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MebeverineDrug
Also called Duspatalin
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
| Study group | Role | What they receive |
|---|---|---|
| Post-cholecystectomy gastrointestinal spasms | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day Receives: Drug: Mebeverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of "Responders" to Duspatalin® Therapy
Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
Measured: 2 weeks
Secondary outcomes (10)
Percentage of "Responders" to Duspatalin® Therapy
Measured: Up to 6 weeks
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.
Measured: Baseline, 2 weeks and up to 6 weeks
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.
Measured: Baseline, 2 weeks and up to 6 weeks
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'.
Measured: Baseline to Week 2
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.
Measured: Baseline, 2 weeks and up to 6 weeks
Health Economic Data
Relevant concomitant medication
Measured: Baseline, up to 6 weeks
Reasons for Continuing Treatment Beyond 2 Weeks
List and rate of reasons
Measured: 2 weeks
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.
Measured: from baseline at Week 6
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.
Measured: change from baseline at Week 6
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'.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-cholecystectomy Gastrointestinal SpasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana Vladimirova, MD, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260154
- Sponsor's protocol ID
- MEBE5002
- Acronym
- ODYSSEY
- Status last verified
- Mar 2019
- First submitted
- 29 Sep 2014
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02260154
- Acronym / sponsor ID
- ODYSSEY / MEBE5002
- Keywords
- Duspatalin, mebeverine, cholecystectomy, gastrointestinal spasm, abdominal pain, dyspepsia, antispasmodics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-cholecystectomy gastrointestinal spasms | – | Drug: MebeverineAdult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MebeverineAlso: DuspatalinSubjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed | Drug | Post-cholecystectomy gastrointestinal spasms |
Primary outcome
Percentage of "Responders" to Duspatalin® Therapy
Time frame: 2 weeks
Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
10 secondary outcomes
Percentage of "Responders" to Duspatalin® Therapy
Time frame: Up to 6 weeks
Changes in Abdominal Pain
Time frame: Baseline, 2 weeks and up to 6 weeks
Changes in Dyspepsia Symptoms
Time frame: 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 Quality of Life
Time frame: Baseline, 2 weeks and up to 6 weeks
Health Economic Data
Time frame: Baseline, up to 6 weeks
Reasons for Continuing Treatment Beyond 2 Weeks
Time frame: 2 weeks
Healths Economic Data 2
Time frame: from baseline at Week 6
Health Economics Data 3
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Vladimirova, MD, PhD study director
Abbott
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-cholecystectomy Gastrointestinal Spasms, run by Abbott at 21 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of "Responders" to Duspatalin® Therapy (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.