Different Doses of Naronapride Vs. Placebo in Gastroparesis

Launched by DR. FALK PHARMA GMBH · Nov 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Naronapride to see if it helps people with a condition called gastroparesis, which affects how well the stomach empties food. Participants will be divided into four groups, where some will receive daily doses of Naronapride (either 10, 20, or 40 mg) and others will receive a placebo, which looks like the medication but has no active ingredients. The goal is to determine the best dose of Naronapride that can help relieve symptoms such as nausea, bloating, and stomach pain.

To be eligible for this trial, participants need to be between 18 and 75 years old, have a specific body weight range, and have been experiencing symptoms of gastroparesis for at least three months. They also need to show that their stomach is not emptying properly based on a specific test. It's important for participants not to have any major gastrointestinal surgeries or conditions that could affect the results. Those who join the trial can expect regular check-ups and monitoring of their symptoms as they take the medication or placebo for a set period. This trial is currently recruiting participants, and it's a great opportunity for those struggling with gastroparesis to potentially benefit from a new treatment.

Gender

ALL

Eligibility 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,