drugset / Trial / NCT05621811

Different Doses of Naronapride vs. Placebo in Gastroparesis

NCT05621811 ↗

Phase 2 Completed 328 enrolled Dr. Falk Pharma GmbH
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.

Timeline

Start
2023-01-03
Primary completion
2025-08-12
Completion
2025-09-04

Outcome

Met primary endpoint

release “MOVE-IT met the primary endpoint with statistically significant improvement in gastroparesis symptoms in 20 mg and 40 mg TID doses vs placebo” drfalkpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naronapride Unknown 10 mg Oral
Subject Naronapride Unknown 20 mg Oral
Subject Naronapride Unknown 40 mg Oral

Indications