Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05175131 | Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders | PHASE3 | COMPLETED | 465 | — | — | Nov 27, 2020 | May 18, 2021 | Sep 16, 2025 | 1 | Russia |
The baseline abdominal pain and bloating/flatulence intensity was determined as the average of the Numeric rating scale (NRS-11) daily assessment during 7 days before randomization. The Week 4 assessment was the average from last 7 days of the corresponding week. The scale is a horizontal 10 cm line with the numbers from 0 to 10 located on it, where 0 is "no pain/bloating", 10 is "most severe pain/bloating you can imagine".
| Arm | Type | Description |
|---|---|---|
| Mebeverine+Simethicone combination | EXPERIMENTAL | three times a day per os |
| mebeverine | ACTIVE_COMPARATOR | three times a day per os |
| simethicone | ACTIVE_COMPARATOR | 80 mg (2 capsules 40 mg) three times a day per os |
| Name | Type | Description |
|---|---|---|
| Mebeverine+Simethicone | DRUG | fixed-dose combination, film-coated tablets, 135 mg + 80 mg |
| Mebeverine | DRUG | Duspatalin®, coated tablets 135 mg |
| Simethicone | DRUG | Espumisan® capsules 40 mg |
Inclusion Criteria: 1. Signed Informed Consent Form; 2. Males and females aged 18 to 75 years old (inclusive); 3. Abdominal pain and bloating/flatulence due to functional bowel disorder (including IBS, chronic functional constipation, chronic functional diarrhea or functional abdominal bloating); 4...