Pure Global
NCT05621811

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
Dr. Falk Pharma GmbH·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Gastroparesis
Drug/Device/Intervention
Naronapride
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Dr. Falk Pharma GmbH
Location
Leuven, Belgium
Timeline & enrollment
Phase
Phase 2
Start date
Jan 03, 2023
End date
Apr 01, 2025
Enrollment
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 gastrostomyGastrostomy statusOther gastritisGastritis, unspecifiedGastric diverticulum
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05621811
Type
Non-Device Trial
About this record

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.