Trials / Completed
CompletedNCT05175131
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
Multicenter, Randomized, Parallel-group, Open-label, Comparative Clinical Study to Evaluate Efficacy and Safety of Mebeverine+Simethicone Fixed-dose Combination Versus Duspatalin® (Mebeverine) and Versus Espumisan® (Simethicone) in Patients With Functional Bowel Disorders With Abdominal Pain and Excess Gas Formation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 465 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The parallel three-group study of efficacy and safety was planned to investigate the reduction in abdominal pain and bloating during treatment with the fixed-dose combination of Mebeverine + Simethicone versus Duspatalin® and Espumisan® as a monotherapy (Protocol No. MESI3001).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mebeverine+Simethicone | fixed-dose combination, film-coated tablets, 135 mg + 80 mg |
| DRUG | Mebeverine | Duspatalin®, coated tablets 135 mg |
| DRUG | Simethicone | Espumisan® capsules 40 mg |
Timeline
- Start date
- 2020-11-27
- Primary completion
- 2021-05-18
- Completion
- 2021-05-18
- First posted
- 2022-01-03
- Last updated
- 2025-09-16
- Results posted
- 2024-01-03
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT05175131. Inclusion in this directory is not an endorsement.