Different Doses of Naronapride vs. Placebo in Gastroparesis

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified March 2026 by Dr. Falk Pharma GmbH
Sponsor
Dr. Falk Pharma GmbH
Information Provided by (Responsible Party)
Dr. Falk Pharma GmbH
Clinicaltrials.gov Identifier
NCT05621811
Other Study ID Numbers:
NAT-19/GPX
First Submitted
November 2, 2022
First Posted
November 17, 2022
Last Update Posted
April 14, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Gastroparesis
Drug: NaronaprideDrug: NaronaprideDrug: NaronaprideDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment328 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleDouble-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 Start DateJanuary 2, 2023
Actual Primary Completion DateAugust 11, 2025
Actual Study Completion DateSeptember 3, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Naronapride 10 mg
Drug: Naronapride
Naronapride is a 5HT-4 agonist
Naronapride 20 mg
Drug: Naronapride
Naronapride is a 5HT-4 agonist
Naronapride 40 mg
Drug: Naronapride
Naronapride is a 5HT-4 agonist
Placebo
Drug: Placebo
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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 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,

Contacts and Locations

Sponsors and CollaboratorsDr. Falk Pharma GmbH
Locations
Dr Falk Investigational Site | Chula Vista California, United States, 91910Dr Falk Investigational Site | Lomita California, United States, 90717Dr Falk Investigational Site | Clearwater Florida, United States, 33756Dr Falk Investigational Site | Doral Florida, United States, 33126Dr Falk Investigational Site | Hollywood Florida, United States, 33021Dr Falk Investigational Site | Maitland Florida, United States, 32751Dr Falk Investigational Site | Miami Florida, United States, 33144Dr Falk Investigational Site | Miami Florida, United States, 33183Dr Falk Investigational Site | Viera Florida, United States, 32940Dr Falk Investigational Site | Topeka Kansas, United States, 66606Dr Falk Investigational Site | Crestview Hills Kentucky, United States, 41017Dr Falk Investigational Site | Houma Louisiana, United States, 70363Dr Falk Investigational Site | Marrero Louisiana, United States, 70072Dr Falk Investigational Site | Flint Michigan, United States, 48439Dr Falk Investigational Site | Flint Michigan, United States, 48503Dr Falk Investigational Site | New York New York, United States, 10033Dr Falk Investigational Site | Tulsa Oklahoma, United States, 74104Dr Falk Investigational Site | Philadelphia Pennsylvania, United States, 19087Dr Falk Investigational Site | Cordova Tennessee, United States, 38018Dr Falk Investigational Site | Nashville Tennessee, United States, 37211Dr Falk Investigational Site | Harlingen Texas, United States, 78550University of Leuven | Leuven , Belgium,