Post-cholecystectomy Gastrointestinal Spasms
Conditions
Keywords
Duspatalin, mebeverine, cholecystectomy, gastrointestinal spasm, abdominal pain, dyspepsia, antispasmodics
Brief 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
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
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders to Duspatalin® Therapy | 2 weeks | Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healths Economic Data 2 | 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. |
| Health Economics Data 3 | 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. |
| Percentage of Responders to Duspatalin® Therapy | Up to 6 weeks | — |
| Changes in Abdominal Pain | 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. |
| Reasons for Continuing Treatment Beyond 2 Weeks | 2 weeks | List and rate of reasons |
| Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form | 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'. |
| Changes in Quality of Life | 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. |
| Health Economic Data | Baseline, up to 6 weeks | Relevant concomitant medication |
| Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2 | 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'. |
| Changes in Dyspepsia Symptoms | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post-cholecystectomy Gastrointestinal Spasms Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
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 | 218 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screening failure | 2 |
Baseline characteristics
| Characteristic | Post-cholecystectomy Gastrointestinal Spasms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 218 Participants |
| Age, Continuous | 51.4 years STANDARD_DEVIATION 10.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 216 Participants |
| Region of Enrollment Russia | 218 participants |
| Sex: Female, Male Female | 180 Participants |
| Sex: Female, Male Male | 38 Participants |
| Working status employed | 137 Participants |
| Working status unemployed | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 218 |
| serious Total, serious adverse events | 0 / 218 |
Outcome results
Primary
Percentage of Responders to Duspatalin® Therapy
Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
Time frame: 2 weeks
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Percentage of Responders to Duspatalin® Therapy | Symptom-free or markedly improved | 63.6 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Percentage of Responders to Duspatalin® Therapy | Other values (slightly improved, unchanged, worse) | 36.4 percentage of participants |
Secondary
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
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Abdominal Pain | change from baseline at Week 2 | -3.7 units on a scale | Standard Deviation 2.28 |
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Abdominal Pain | change from baseline at Week 6 | -4.4 units on a scale | Standard Deviation 2.36 |
Secondary
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
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Dyspepsia Symptoms | change from baseline at Week 2 | -2.0 units on a scale | Standard Deviation 2.29 |
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Dyspepsia Symptoms | change from baseline at Week 6 | -2.3 units on a scale | Standard Deviation 2.41 |
Secondary
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
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Quality of Life | change from baseline at Week 2 | 16.802 units on a scale | Standard Deviation 11.8489 |
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Quality of Life | change from baseline at Week 6 | 21.737 units on a scale | Standard Deviation 13.4339 |
Secondary
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
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form | Positive | 38.25 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form | Negative | 2.30 percentage of participants |
Secondary
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
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2 | Positive | 40.00 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2 | Negative | 2.00 percentage of participants |
Secondary
Health Economic Data
Relevant concomitant medication
Time frame: Baseline, up to 6 weeks
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Barbiturates | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Beta blocking against agents, selective | 4.1 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Biguaniges | 0.9 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Bile acid preparations | 10.1 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Bioflavonoids | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Blood transfusion, auxilary products | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Beta blocking agents, and other antihypertensives | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Beta blocking agents, thiazides | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Anti inflammatory | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | ACE inhibitors | 9.6 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Alpha adrenoreceptor antagonist | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Aluminium compounds | 2.3 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Angiotensine II antagonist | 1.4 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Anti arrhythmics | 0.5 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Health Economic Data | Anti diarrheal | 1.4 percentage of participants |
Secondary
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
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200mg twice a day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Health Economics Data 3 | -2.1 Number of days | Standard Deviation 3.48 |
Secondary
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
Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Healths Economic Data 2 | -0.9 number of visits | Standard Deviation 1.19 |
Secondary
Percentage of Responders to Duspatalin® Therapy
Time frame: Up to 6 weeks
Population: Extended set includes those patients who completed at least 6 weeks treatment of Duspatalin
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Percentage of Responders to Duspatalin® Therapy | 79.0 percentage of participants |
Secondary
Reasons for Continuing Treatment Beyond 2 Weeks
List and rate of reasons
Time frame: 2 weeks
Population: Extended Set includes those patients who completed at least 6 weeks treatment of Duspatalin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post-cholecystectomy Gastrointestinal Spasms | Reasons for Continuing Treatment Beyond 2 Weeks | Tend to treat beyond 2 weeks | 4.0 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Reasons for Continuing Treatment Beyond 2 Weeks | Expectation in higher effectiveness | 84.2 percentage of participants |
| Post-cholecystectomy Gastrointestinal Spasms | Reasons for Continuing Treatment Beyond 2 Weeks | Maintenance of achieved effect | 11.9 percentage of participants |