Comparing different doses of Naronapride to placebo for treating 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
This study is testing if different doses of a medication called Naronapride can help people with gastroparesis feel better by reducing symptoms like nausea, vomiting, and abdominal pain compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Dr. Falk Pharma GmbH Industry-sponsored |
| Locations | 22 sites (Chula Vista, California and 21 other locations) |
| Trial ID | NCT05621811 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial is a double-blind, randomized, multicenter, placebo-controlled study designed to evaluate the efficacy of three different doses of Naronapride (10, 20, and 40 mg) compared to a placebo in patients suffering from gastroparesis. Participants will be assigned to one of four treatment groups in a parallel group comparison format. The study aims to assess the impact of Naronapride on the cardinal symptoms of gastroparesis, including nausea, vomiting, and abdominal pain, over a specified treatment period.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 to 75 with idiopathic or diabetic gastroparesis and specific symptom criteria.
Not a fit: Patients with mechanical obstructions, structural diseases, or uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new effective treatment option for patients suffering from gastroparesis.
How similar studies have performed: While this approach is being tested in this trial, similar studies have shown promise in treating gastroparesis with pharmacological interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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,
Where this trial is running
Chula Vista, California and 21 other locations
- Dr Falk Investigational Site — Chula Vista, California, United States (Recruiting)
- Dr Falk Investigational Site — Lomita, California, United States (Recruiting)
- Dr Falk Investigational Site — Clearwater, Florida, United States (Recruiting)
- Dr Falk Investigational Site — Doral, Florida, United States (Recruiting)
- Dr Falk Investigational Site — Hollywood, Florida, United States (Recruiting)
- Dr Falk Investigational Site — Maitland, Florida, United States (Recruiting)
- Dr Falk Investigational Site — Miami, Florida, United States (Recruiting)
- Dr Falk Investigational Site — Miami, Florida, United States (Recruiting)
- Dr Falk Investigational Site — Viera, Florida, United States (Recruiting)
- Dr Falk Investigational Site — Topeka, Kansas, United States (Recruiting)
- Dr Falk Investigational Site — Crestview Hills, Kentucky, United States (Recruiting)
- Dr Falk Investigational Site — Houma, Louisiana, United States (Recruiting)
- Dr Falk Investigational Site — Marrero, Louisiana, United States (Recruiting)
- Dr Falk Investigational Site — Flint, Michigan, United States (Recruiting)
- Dr Falk Investigational Site — Flint, Michigan, United States (Recruiting)
- Dr Falk Investigational Site — New York City, New York, United States (Recruiting)
- Dr Falk Investigational Site — Tulsa, Oklahoma, United States (Recruiting)
- Dr Falk Investigational Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Dr Falk Investigational Site — Cordova, Tennessee, United States (Recruiting)
- Dr Falk Investigational Site — Nashville, Tennessee, United States (Recruiting)
- Dr Falk Investigational Site — Harlingen, Texas, United States (Recruiting)
- University of Leuven — Leuven, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.