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Mebeverine+Simethicone · 1 trial · 1 indication
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...
Mebeverine+Simethicone is an investigational small molecule combination being developed for the treatment of Functional Bowel Disorder, a gastrointestinal condition. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Mebeverine+Simethicone is being developed by Abbott Laboratories, a company listed on the stock exchange under the ticker ABT. The drug is currently in Phase 3 clinical development for Functional Bowel Disorder.
Mebeverine+Simethicone is in Phase 3 clinical development. It is an investigational drug for Functional Bowel Disorder and has not yet received regulatory approval. One Phase 3 trial has been completed as part of its development program.
Mebeverine+Simethicone has one completed Phase 3 clinical trial registered as NCT05175131, titled 'Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders'. This randomized, active-controlled study enrolled 465 participants in Russia and was not double-blinded.
Mebeverine+Simethicone is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Functional Bowel Disorder. The completed Phase 3 trial, NCT05175131, evaluated its efficacy and safety but regulatory approval has not been granted.