drugset / Trial / NCT03119766

Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients

NCT03119766 ↗

Phase 4 Completed 370 enrolled Materia Medica Holding
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Purpose of the study: To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.

Timeline

Start
2017-06-28
Primary completion
2020-01-11
Completion
2020-01-11

Outcome

Met primary endpoint

registry analysis (superiority test); Kolofort vs Placebo; p = 0.041; Mean Difference (Final Values) 0.94 (95% CI 0.04 to 1.85); ANOVA NCT03119766 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Kolofort Unknown 2 unknown Oral

Indications