Trials / Completed
CompletedNCT05621811
Different Doses of Naronapride vs. Placebo in Gastroparesis
Double-blind, Randomised, Placebo-controlled, Dose-finding Phase IIb Trial to Evaluate the Efficacy, Safety, and Tolerability of a 12-week-treatment With Naronapride in Adult Participants With at Least Moderate Idiopathic or Diabetic Gastroparesis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 328 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naronapride | Naronapride is a 5HT-4 agonist |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2023-01-03
- Primary completion
- 2025-08-12
- Completion
- 2025-09-04
- First posted
- 2022-11-18
- Last updated
- 2026-04-15
Locations
22 sites across 2 countries: United States, Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05621811. Inclusion in this directory is not an endorsement.