drugset / Trial / NCT05175131

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

NCT05175131

Phase 3 Completed 465 enrolled Abbott
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mebeverine Small molecule 135 mg Oral
Comparator Simethicone Other / unclassified 40 mg Oral
Comparator Simethicone Other / unclassified 80 mg Oral

Indications