Different Doses of Naronapride vs. Placebo in Gastroparesis

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.

Conditions

Gastroparesis

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Study Overview

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Study Details

Study overview

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.

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

Different Doses of Naronapride vs. Placebo in Gastroparesis

Condition
Gastroparesis
Intervention / Treatment

-

Contacts and Locations

Lomita

Dr Falk Investigational Site, Lomita, California, United States, 90717

Clearwater

Dr Falk Investigational Site, Clearwater, Florida, United States, 33756

Hollywood

Dr Falk Investigational Site, Hollywood, Florida, United States, 33021

Maitland

Dr Falk Investigational Site, Maitland, Florida, United States, 32751

Miami

Dr Falk Investigational Site, Miami, Florida, United States, 33144

Miami

Dr Falk Investigational Site, Miami, Florida, United States, 33183

Viera

Dr Falk Investigational Site, Viera, Florida, United States, 32940

Houma

Dr Falk Investigational Site, Houma, Louisiana, United States, 70363

Marrero

Dr Falk Investigational Site, Marrero, Louisiana, United States, 70072

Flint

Dr Falk Investigational Site, Flint, Michigan, United States, 48439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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),
  • * 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,

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dr. Falk Pharma GmbH,

Study Record Dates

2025-04