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Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders

NCT05175131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2025-09-16

Study results available
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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

  • Functional Bowel Disorder

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-27
Primary Completion
2021-05-18
Completion
2021-05-18

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175131 on ClinicalTrials.gov