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Different Doses of Naronapride vs. Placebo in Gastroparesis - Trial NCT05621811

Access comprehensive clinical trial information for NCT05621811 through Pure Global AI's free database. This Phase 2 trial is sponsored by Dr. Falk Pharma GmbH and is currently Recruiting. The study focuses on Gastroparesis. Target enrollment is 320 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05621811
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05621811
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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

Study Focus

Gastroparesis

Naronapride

Interventional

drug

Sponsor & Location

Dr. Falk Pharma GmbH

Leuven, Belgium

Timeline & Enrollment

Phase 2

Jan 03, 2023

Apr 01, 2025

320 participants

Primary Outcome

Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12

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.

ICD-10 Classifications

Attention to gastrostomy
Gastrostomy status
Other gastritis
Gastritis, unspecified
Gastric diverticulum

Data Source

ClinicalTrials.gov

NCT05621811

Non-Device Trial