At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 465 enrolled
Drug / intervention
Mebeverine+Simethicone +2 moredrug
Likely dose
Mebeverine+Simethicone 135 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Mebeverine+Simethicone, Mebeverine, and 1 other intervention for Functional Bowel Disorder. Completed, enrolled 465 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctional Bowel Disorder
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartNov 2020
Primary CompletionMay 2021
First PostedJan 2022
TodayJul 2026
First PostedJan 3, 2022
Enrollment StartNov 27, 2020
Primary CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.5 years ago
Interventions
Mebeverine+Simethiconedrug
fixed-dose combination, film-coated tablets, 135 mg + 80 mg
Mebeverinedrug
Duspatalin®, coated tablets 135 mg
Simethiconedrug
Espumisan® capsules 40 mg