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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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),

Locations
United States
California
Dr Falk Investigational Site
RECRUITING
Chula Vista
Dr Falk Investigational Site
RECRUITING
Lomita
Florida
Dr Falk Investigational Site
RECRUITING
Clearwater
Dr Falk Investigational Site
RECRUITING
Doral
Dr Falk Investigational Site
RECRUITING
Hollywood
Dr Falk Investigational Site
RECRUITING
Maitland
Dr Falk Investigational Site
RECRUITING
Miami
Dr Falk Investigational Site
RECRUITING
Miami
Dr Falk Investigational Site
RECRUITING
Viera
Kansas
Dr Falk Investigational Site
RECRUITING
Topeka
Kentucky
Dr Falk Investigational Site
RECRUITING
Crestview Hills
Louisiana
Dr Falk Investigational Site
RECRUITING
Houma
Dr Falk Investigational Site
RECRUITING
Marrero
Michigan
Dr Falk Investigational Site
RECRUITING
Flint
Dr Falk Investigational Site
RECRUITING
Flint
New York
Dr Falk Investigational Site
RECRUITING
New York
Oklahoma
Dr Falk Investigational Site
RECRUITING
Tulsa
Pennsylvania
Dr Falk Investigational Site
RECRUITING
Philadelphia
Tennessee
Dr Falk Investigational Site
RECRUITING
Cordova
Dr Falk Investigational Site
RECRUITING
Nashville
Texas
Dr Falk Investigational Site
RECRUITING
Harlingen
Other Locations
Belgium
University of Leuven
RECRUITING
Leuven
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 320
Treatments
Experimental: Naronapride 10 mg
Experimental: Naronapride 20 mg
Experimental: Naronapride 40 mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Dr. Falk Pharma GmbH

This content was sourced from clinicaltrials.gov