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It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine maleate in the efficacy and safety.
Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and safety.
For subjects with IBS, Fenoverine and Trimebutine will be administered orally for 8 weeks; Fenoverine 100mg capsule three times a day and Trimebutine 150mg tablet three times a day. Because one is capsule and the other is tablet, double dummy design will be used. Efficacy is evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of the scheduled medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenoverine | Experimental | Fenoverine 100mg three times a day will be administered for 8 weeks. |
|
| Trimebutine | Active Comparator | Trimebutine maleate 150mg three times a day will be administered for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenoverine | Drug | Fenoverine 100mg three times a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of subjects with improvement in abdominal pain or discomfort | the proportion of subjects who experienced more than 30% improvement in abdominal pain or discomfort score with visual analog scale at week 8 compared to baseline | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| BSS scores (each and total) | BSS score will be checked for four IBS symptoms; abdominal pain or discomfort, bloating, constipation, diarrhea. The scores will be compared for its chronological changes between trial groups. Total BSS score will be the sum of the scores of four symptoms measured. | week 4, 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon Tae Jeen, Dr. | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | South Korea | ||||
| Hallym University Sacred Heart Hospital |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C048314 | fenoverine |
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| Timebutine | Drug | Timebutine maleate 150mg three times a day for 8 weeks |
|
|
| overall BSS score |
IBS symptom will be assessed overally by subjects at day 1, week 4, and week 8. The scores will be compared chronologically between groups. |
| Week 4, 8 |
| subject's satisfaction with treatment | Subject's satisfaction with the treatment is measured using visual analog scale. | week 4, 8 |
| adverse event | Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary. | at each visit or contact until 4 weeks after the last dose |
| Anyang |
| South Korea |
| Kangwon National University Hospital | Chuncheon | South Korea |
| Gachon University Gil Hospital | Incheon | South Korea |
| Inje University Seoul Paik Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |