Trial Outcomes & Findings for Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm (NCT NCT02260154)
NCT ID: NCT02260154
Last Updated: 2019-06-06
Results Overview
Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
COMPLETED
220 participants
2 weeks
2019-06-06
Participant Flow
Participant milestones
| Measure |
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 bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed
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|---|---|
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Overall Study
STARTED
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220
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Overall Study
COMPLETED
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218
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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 bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed
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|---|---|
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Overall Study
Screening failure
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2
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Baseline Characteristics
Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm
Baseline characteristics by cohort
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=218 Participants
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
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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218 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
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Age, Continuous
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51.4 years
STANDARD_DEVIATION 10.29 • n=99 Participants
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Sex: Female, Male
Female
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180 Participants
n=99 Participants
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Sex: Female, Male
Male
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38 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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216 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
Russia
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218 participants
n=99 Participants
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Working status
employed
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137 Participants
n=99 Participants
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Working status
unemployed
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81 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 2 weeksPopulation: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=218 Participants
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
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|---|---|
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Percentage of "Responders" to Duspatalin® Therapy
Symptom-free or markedly improved
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63.6 percentage of participants
Interval 56.8 to 70.0
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Percentage of "Responders" to Duspatalin® Therapy
Other values (slightly improved, unchanged, worse)
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36.4 percentage of participants
Interval 30.0 to 43.2
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SECONDARY outcome
Timeframe: Up to 6 weeksPopulation: Extended set includes those patients who completed at least 6 weeks treatment of Duspatalin
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=101 Participants
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
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|---|---|
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Percentage of "Responders" to Duspatalin® Therapy
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79.0 percentage of participants
Interval 69.7 to 86.5
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SECONDARY outcome
Timeframe: Baseline, 2 weeks and up to 6 weeksPopulation: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
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.
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=217 Participants
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
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|---|---|
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Changes in Abdominal Pain
change from baseline at Week 2
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-3.7 units on a scale
Standard Deviation 2.28
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Changes in Abdominal Pain
change from baseline at Week 6
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-4.4 units on a scale
Standard Deviation 2.36
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SECONDARY outcome
Timeframe: Baseline, 2 weeks and up to 6 weeksPopulation: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
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.
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=217 Participants
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
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|---|---|
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Changes in Dyspepsia Symptoms
change from baseline at Week 2
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-2.0 units on a scale
Standard Deviation 2.29
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Changes in Dyspepsia Symptoms
change from baseline at Week 6
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-2.3 units on a scale
Standard Deviation 2.41
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SECONDARY outcome
Timeframe: Baseline to Week 2Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
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'.
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=217 Participants
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
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|---|---|
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Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form
Positive
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38.25 percentage of participants
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Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form
Negative
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2.30 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, 2 weeks and up to 6 weeksPopulation: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
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.
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=217 Participants
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
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|---|---|
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Changes in Quality of Life
change from baseline at Week 2
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16.802 units on a scale
Standard Deviation 11.8489
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Changes in Quality of Life
change from baseline at Week 6
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21.737 units on a scale
Standard Deviation 13.4339
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SECONDARY outcome
Timeframe: Baseline, up to 6 weeksPopulation: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
Relevant concomitant medication
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=218 Participants
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
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|---|---|
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Health Economic Data
ACE inhibitors
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9.6 percentage of participants
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Health Economic Data
Alpha adrenoreceptor antagonist
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0.5 percentage of participants
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Health Economic Data
Aluminium compounds
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2.3 percentage of participants
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Health Economic Data
Angiotensine II antagonist
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1.4 percentage of participants
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Health Economic Data
Anti arrhythmics
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0.5 percentage of participants
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Health Economic Data
Anti diarrheal
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1.4 percentage of participants
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Health Economic Data
Anti inflammatory
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0.5 percentage of participants
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Health Economic Data
Barbiturates
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0.5 percentage of participants
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Health Economic Data
Beta blocking against agents, selective
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4.1 percentage of participants
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Health Economic Data
Biguaniges
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0.9 percentage of participants
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Health Economic Data
Bile acid preparations
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10.1 percentage of participants
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Health Economic Data
Bioflavonoids
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0.5 percentage of participants
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Health Economic Data
Blood transfusion, auxilary products
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0.5 percentage of participants
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Health Economic Data
Beta blocking agents, and other antihypertensives
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0.5 percentage of participants
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Health Economic Data
Beta blocking agents, thiazides
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0.5 percentage of participants
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SECONDARY outcome
Timeframe: 2 weeksPopulation: Extended Set includes those patients who completed at least 6 weeks treatment of Duspatalin
List and rate of reasons
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=101 Participants
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
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|---|---|
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Reasons for Continuing Treatment Beyond 2 Weeks
Expectation in higher effectiveness
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84.2 percentage of participants
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Reasons for Continuing Treatment Beyond 2 Weeks
Tend to treat beyond 2 weeks
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4.0 percentage of participants
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Reasons for Continuing Treatment Beyond 2 Weeks
Maintenance of achieved effect
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11.9 percentage of participants
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SECONDARY outcome
Timeframe: from baseline at Week 6Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
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.
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=101 Participants
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
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|---|---|
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Healths Economic Data 2
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-0.9 number of visits
Standard Deviation 1.19
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SECONDARY outcome
Timeframe: change from baseline at Week 6Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200mg twice a day
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.
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=57 Participants
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
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|---|---|
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Health Economics Data 3
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-2.1 Number of days
Standard Deviation 3.48
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SECONDARY outcome
Timeframe: Baseline to Week 6Population: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
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'.
Outcome measures
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=100 Participants
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
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|---|---|
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Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2
Positive
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40.00 percentage of participants
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Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2
Negative
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2.00 percentage of participants
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Adverse Events
Post-cholecystectomy Gastrointestinal Spasms
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Post-cholecystectomy Gastrointestinal Spasms
n=218 participants at risk
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
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|---|---|
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Skin and subcutaneous tissue disorders
Dermatitis allergic
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0.46%
1/218 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60