Different Doses of Naronapride vs. Placebo in 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 Criteria:Men and women between ≥18 and ≤75 years of ageHistory of idiopathic or diabetic gastroparesis cardinal symptoms for ≥3 monthsEvidence of delayed gastric emptyingAverage weekly total symptom score of ≥2.0Body Mass Index ≥16 and <35 kg/m2Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging techniqueExclusion Criteria:Participants without access to an internet-capable terminal and/or without an own e-mail addressHistory of major gastrointestinal surgeryIntrapyloric botulinum toxin injection within 12 monthsGastric stimulator implantKnown secondary causes of gastroparesisPresence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis