Different Doses of Naronapride vs. Placebo in Gastroparesis

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: ATI 7505

Criteria

Inclusion Criteria:

• Men and women between ≥18 and ≤75 years of age

• History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥3 months

• Evidence of delayed gastric emptying

• Average weekly total symptom score of ≥2.0

• Body Mass Index ≥16 and <35 kg/m2

• Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique

Exclusion Criteria:

• Participants without access to an internet-capable terminal and/or without an own e-mail address

• History of major gastrointestinal surgery

• Intrapyloric botulinum toxin injection within 12 months

• Gastric stimulator implant

• Known secondary causes of gastroparesis

• Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis