CompletedNCT02260154ODYSSEYUpdated Jun 6, 2019Results posted

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

An observational study in Post-cholecystectomy Gastrointestinal Spasms, sponsored by Abbott. Completed at 21 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-06.

Sponsored by Abbott · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 220
Ages: 18 Years to 65 Years
Sex: All

Study 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

Conditions studied

Post-cholecystectomy Gastrointestinal Spasms

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Keywords

Duspatalin
mebeverine
cholecystectomy
gastrointestinal spasm
abdominal pain
dyspepsia
antispasmodics

In context

Muscle Cramp

95 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.

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Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Primary care clinic

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 220 participants (actual)
Patient registry: No

Groups and cohorts

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

Interventions

DrugMebeverine
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
Also known as: Duspatalin

What researchers measure

Primary outcomes

Percentage of "Responders" to Duspatalin® Therapy
Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
Time frame: 2 weeks

Secondary outcomes

Percentage of "Responders" to Duspatalin® Therapy
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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.
Time frame: Baseline, 2 weeks and up to 6 weeks
Health Economic Data
Relevant concomitant medication
Time frame: Baseline, up to 6 weeks
Reasons for Continuing Treatment Beyond 2 Weeks
List and rate of reasons
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: Baseline to Week 6

Results

Posted Jun 6, 2019

Participant flow

Participant flow — Overall Study
Milestone	Post-cholecystectomy Gastrointestinal Spasms
Started	220
Completed	218
Not completed	2
Withdrew: Screening failure	2

Outcome measures

PrimaryPercentage of "Responders" to Duspatalin® Therapy

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

Time frame:: 2 weeks
Reported as:: Number · percentage of participants

Percentage of "Responders" to Duspatalin® Therapy
percentage of participants	Post-cholecystectomy Gastrointestinal Spasms
Symptom-free or markedly improved	63.6 (56.8 to 70.0)
Other values (slightly improved, unchanged, worse)	36.4 (30.0 to 43.2)

SecondaryPercentage of "Responders" to Duspatalin® Therapy

Time frame:: Up to 6 weeks
Reported as:: Number · percentage of participants

Percentage of "Responders" to Duspatalin® Therapy
percentage of participants	Post-cholecystectomy Gastrointestinal Spasms
Percentage of "Responders" to Duspatalin® Therapy	79.0 (69.7 to 86.5)

SecondaryChanges 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.

Time frame:: Baseline, 2 weeks and up to 6 weeks
Reported as:: Mean · units on a scale

Changes in Abdominal Pain
units on a scale	Post-cholecystectomy Gastrointestinal Spasms
change from baseline at Week 2	-3.7 ± 2.28
change from baseline at Week 6	-4.4 ± 2.36

SecondaryChanges 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.

Time frame:: Baseline, 2 weeks and up to 6 weeks
Reported as:: Mean · units on a scale

Changes in Dyspepsia Symptoms
units on a scale	Post-cholecystectomy Gastrointestinal Spasms
change from baseline at Week 2	-2.0 ± 2.29
change from baseline at Week 6	-2.3 ± 2.41

SecondaryChanges 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'.

Time frame:: Baseline to Week 2
Reported as:: Number · percentage of participants

Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form
percentage of participants	Post-cholecystectomy Gastrointestinal Spasms
Positive	38.25
Negative	2.30

SecondaryChanges 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.

Time frame:: Baseline, 2 weeks and up to 6 weeks
Reported as:: Mean · units on a scale

Changes in Quality of Life
units on a scale	Post-cholecystectomy Gastrointestinal Spasms
change from baseline at Week 2	16.802 ± 11.8489
change from baseline at Week 6	21.737 ± 13.4339

SecondaryHealth Economic Data

Relevant concomitant medication

Time frame:: Baseline, up to 6 weeks
Reported as:: Number · percentage of participants

Health Economic Data
percentage of participants	Post-cholecystectomy Gastrointestinal Spasms
ACE inhibitors	9.6
Alpha adrenoreceptor antagonist	0.5
Aluminium compounds	2.3
Angiotensine II antagonist	1.4
Anti arrhythmics	0.5
Anti diarrheal	1.4
Anti inflammatory	0.5
Barbiturates	0.5
Beta blocking against agents, selective	4.1
Biguaniges	0.9
Bile acid preparations	10.1
Bioflavonoids	0.5
Blood transfusion, auxilary products	0.5
Beta blocking agents, and other antihypertensives	0.5
Beta blocking agents, thiazides	0.5

SecondaryReasons for Continuing Treatment Beyond 2 Weeks

List and rate of reasons

Time frame:: 2 weeks
Reported as:: Number · percentage of participants

Reasons for Continuing Treatment Beyond 2 Weeks
percentage of participants	Post-cholecystectomy Gastrointestinal Spasms
Expectation in higher effectiveness	84.2
Tend to treat beyond 2 weeks	4.0
Maintenance of achieved effect	11.9

SecondaryHealths 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.

Time frame:: from baseline at Week 6
Reported as:: Mean · number of visits

Healths Economic Data 2
number of visits	Post-cholecystectomy Gastrointestinal Spasms
Healths Economic Data 2	-0.9 ± 1.19

SecondaryHealth 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.

Time frame:: change from baseline at Week 6
Reported as:: Mean · Number of days

Health Economics Data 3
Number of days	Post-cholecystectomy Gastrointestinal Spasms
Health Economics Data 3	-2.1 ± 3.48

SecondaryChanges 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'.

Time frame:: Baseline to Week 6
Reported as:: Number · percentage of participants

Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2
percentage of participants	Post-cholecystectomy Gastrointestinal Spasms
Positive	40.00
Negative	2.00

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Post-cholecystectomy Gastrointestinal Spasms	—	0/218 (0%)	1/218 (0.5%)

Most frequent other events

Most frequent other events
Event	Post-cholecystectomy Gastrointestinal Spasms
Dermatitis allergicSkin and subcutaneous tissue disorders	1/218

Baseline characteristics

Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day

Age, Categorical
Age, Categorical(Participants)	Post-cholecystectomy Gastrointestinal Spasms
<=18 years	0
Between 18 and 65 years	218
>=65 years	0

Age, Continuous
Age, Continuous(years)	Post-cholecystectomy Gastrointestinal Spasms
Mean	51.4 ± 10.29

Sex: Female, Male
Sex: Female, Male(Participants)	Post-cholecystectomy Gastrointestinal Spasms
Female	180
Male	38

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Post-cholecystectomy Gastrointestinal Spasms
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	216
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Post-cholecystectomy Gastrointestinal Spasms
Russia	218

Working status
Working status(Participants)	Post-cholecystectomy Gastrointestinal Spasms
employed	137
unemployed	81

Study locations

21 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02260154
Lead sponsor: Abbott
Responsible party: Sponsor
First posted: Oct 9, 2014
Start date: Jul 2015
Primary completion: Oct 2016
Completion: Oct 2016
Results posted: Jun 6, 2019
Last update: Jun 6, 2019

Study contacts

Tatiana Vladimirova, MD, PhD

study director · Abbott

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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