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RECRUITINGPHASE2

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

NCT05621811•Dr. Falk Pharma GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women between ≥18 and ≤75 years of age,
•Body Mass Index (BMI) ≥16 and \<35 kg/m2 ,
•History of idiopathic or diabetic gastroparesis cardinal symptoms (e.g., nausea, vomiting, early satiety, postprandial fullness, bloating or upper abdominal pain) for ≥3 months,
•Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 ≥ 85.33 minutes (≥ 90th percentile of normative data) during the screening phase,
•Average weekly total symptom score of the ANMS GCSI-DD ≥2.0 based on the daily symptom scores recorded for at least 5 of 7 consecutive days in the week prior to Baseline,
•Participants with a type I or type II diabetes mellitus diagnosis must have a controlled diabetes mellitus defined as HbA1c ≤11% under stable antidiabetic medication,
•Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy during screening phase (previous endoscopic results within 12 months are acceptable, if no relevant changes in patient's disease status occurred since that time),
•No evidence of intestinal stenosis as determined by an imaging technique (i.e., either abdominal sonography, Magnetic resonance imaging \[MRI\] or imaging by computed tomography \[CT\] during screening phase (previous MRI/CT imaging or sonography results within 12 months are acceptable, if no relevant changes occurred in patient's disease status since that time),

Exclusion Criteria

•History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, colectomy,
•Intrapyloric botulinum toxin injection within 12 months,
•Gastric stimulator implant,
•Known secondary causes of gastroparesis including but not limited to Parkinson's Disease, cancer, or connective tissue diseases,

Locations (22)

Dr Falk Investigational Site

Chula Vista, California, United States

Dr Falk Investigational Site

Lomita, California, United States

Dr Falk Investigational Site

Clearwater, Florida, United States

Dr Falk Investigational Site

Doral, Florida, United States

Dr Falk Investigational Site

Hollywood, Florida, United States

Dr Falk Investigational Site

Maitland, Florida, United States

Dr Falk Investigational Site

Miami, Florida, United States

Dr Falk Investigational Site

Miami, Florida, United States

Dr Falk Investigational Site

Viera, Florida, United States

Dr Falk Investigational Site

Topeka, Kansas, United States

Key Dates

Start Date

January 3, 2023

Primary Completion Date

September 1, 2025

Completion Date

December 1, 2025

Last Updated

February 6, 2025

Enrollment

320

ESTIMATED participants

Conditions

Gastroparesis

Interventions

Naronapride

DRUG

Placebo

DRUG

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Different Doses of Naronapride Vs. Placebo in Gastroparesis

Inclusion Criteria

Exclusion Criteria

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Growth Hormone for the Treatment of Gastroparesis

Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis

Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients

Use of EndoFLIP and Manometry Prior to G-POEM