| Primary | Percentage of "Responders" to Duspatalin® Therapy | Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 weeks | | | | ID | Title | Description |
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| OG000 | 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 |
| | | Title | Denominators | Categories |
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| Symptom-free or markedly improved | | | | Other values (slightly improved, unchanged, worse) | | |
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| Secondary | Percentage of "Responders" to Duspatalin® Therapy | | Extended set includes those patients who completed at least 6 weeks treatment of Duspatalin | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 6 weeks | | | | ID | Title | Description |
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| OG000 | 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 |
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| 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. | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 2 weeks and up to 6 weeks | | | | ID | Title | Description |
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| OG000 | 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 |
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| 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. | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 2 weeks and up to 6 weeks | | | | ID | Title | Description |
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| OG000 | 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 |
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| 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'. | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Number | | percentage of participants | | Baseline to Week 2 | | | | ID | Title | Description |
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| OG000 | 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 |
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| 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. | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 2 weeks and up to 6 weeks | | | | ID | Title | Description |
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| OG000 | 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 |
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| Secondary | Health Economic Data | Relevant concomitant medication | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Number | | percentage of participants | | Baseline, up to 6 weeks | | | | ID | Title | Description |
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| OG000 | 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 |
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| Secondary | Reasons for Continuing Treatment Beyond 2 Weeks | | Extended Set includes those patients who completed at least 6 weeks treatment of Duspatalin | Posted | | Number | | percentage of participants | | 2 weeks | | | | ID | Title | Description |
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| OG000 | 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 |
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| 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. | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Mean | Standard Deviation | number of visits | | from baseline at Week 6 | | | | ID | Title | Description |
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| OG000 | 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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| 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. | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200mg twice a day | Posted | | Mean | Standard Deviation | Number of days | | change from baseline at Week 6 | | | | ID | Title | Description |
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| OG000 | 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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| 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'. | Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day | Posted | | Number | | percentage of participants | | Baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | 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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