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Different Doses of Naronapride vs. Placebo in Gastroparesis

NCT05621811 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2026-04-15

No results posted yet for this study

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

DRUG

Naronapride

Naronapride is a 5HT-4 agonist

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2025-08-12
Completion
2025-09-04
FDA Drug
Yes

Countries

  • United States
  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05621811 on ClinicalTrials.gov