drugset / Trial / NCT05621811
Different Doses of Naronapride vs. Placebo in Gastroparesis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naronapride | Unknown | 10 mg | Oral |
| Subject | Naronapride | Unknown | 20 mg | Oral |
| Subject | Naronapride | Unknown | 40 mg | Oral |