Different Doses of Naronapride vs. Placebo in Gastroparesis
Key facts
- Where
- Chula Vista, Clearwater, Cleveland, Cordova, Crestview Hills, Doral, Flint, Harlingen, Hollywood, Houma, Kansas City, Lomita, Maitland, Marrero, Miami, Nashville, New York, Philadelphia, Topeka, Tulsa, and Viera, United StatesSee the 21 sites
- Phase
- Phase 2
Where in United States
- Dr Falk Investigational SiteChula Vista, United StatesNo longer taking part
- Dr Falk Investigational SiteClearwater, United StatesNo longer taking part
- Dr Falk Investigational SiteCleveland, United StatesNo longer taking part
- Dr Falk Investigational SiteCordova, United StatesNo longer taking part
- Dr Falk Investigational SiteCrestview Hills, United StatesNo longer taking part
- Dr Falk Investigational SiteDoral, United StatesNo longer taking part
- Dr Falk Investigational SiteFlint, United StatesNo longer taking part
- Dr Falk Investigational SiteHarlingen, United StatesNo longer taking part
- Dr Falk Investigational SiteHollywood, United StatesNo longer taking part
- Dr Falk Investigational SiteHouma, United StatesNo longer taking part
- Dr Falk Investigational SiteKansas City, United StatesNo longer taking part
- Dr Falk Investigational SiteLomita, United StatesNo longer taking part
- Dr Falk Investigational SiteMaitland, United StatesNo longer taking part
- Dr Falk Investigational SiteMarrero, United StatesNo longer taking part
- Dr Falk Investigational SiteMiami, United StatesNo longer taking part
- Dr Falk Investigational SiteNashville, United StatesNo longer taking part
- Dr Falk Investigational SiteNew York, United StatesNo longer taking part
- Dr Falk Investigational SitePhiladelphia, United StatesNo longer taking part
- Dr Falk Investigational SiteTopeka, United StatesNo longer taking part
- Dr Falk Investigational SiteTulsa, United StatesNo longer taking part
- Dr Falk Investigational SiteViera, United StatesNo longer taking part
Trial details
- Who runs it
- Dr. Falk Pharma GmbH
- Trial code
- NCT05621811EU 2023-510195-31-00
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Gastric stimulator implant,; History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, colectomy,; Known secondary causes of gastroparesis including but not limited to Parkinson's Disease, cancer, or connective tissue diseases,; Intrapyloric botulinum toxin injection within 12 months,.