MOVE-IT: Different Doses of Naronapride vs. Placebo in Gastroparesis

Dr. Falk Pharma GmbH (Industry)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
320 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
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
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Naronapride 10 mg

Drug: Naronapride
Naronapride is a 5HT-4 agonist

Experimental: Naronapride 20 mg

Drug: Naronapride
Naronapride is a 5HT-4 agonist

Experimental: Naronapride 40 mg

Drug: Naronapride
Naronapride is a 5HT-4 agonist

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Men and women between ≥18 and ≤75 years of age

  • History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥3 months

  • Evidence of delayed gastric emptying

  • Average weekly total symptom score of ≥2.0

  • Body Mass Index ≥16 and <35 kg/m2

  • Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique

Exclusion Criteria:
  • Participants without access to an internet-capable terminal and/or without an own e-mail address

  • History of major gastrointestinal surgery

  • Intrapyloric botulinum toxin injection within 12 months

  • Gastric stimulator implant

  • Known secondary causes of gastroparesis

  • Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Dr. Falk Pharma GmbH


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Dr. Falk Pharma GmbH Identifier:
Other Study ID Numbers:
  • NAT-19/GPX
First Posted:
Nov 18, 2022
Last Update Posted:
Nov 18, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Dr. Falk Pharma GmbH
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2022