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
- Conditions
- delayed gastric emptyinggastroplegia10017977
- Registration Number
- NL-OMON53662
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
• 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
• 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
• Active gastric stimulator implant
• Known secondary causes of gastroparesis
• Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux
oesophagitis, acute gastritis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change of the ANMS GCSI-DD average weekly total symptom score from BSL (visit<br /><br>2) to EOT/WD (visit 6). The daily ANMS GCSI-DD total symptom score is the sum<br /><br>of the score values (0-4) of the 5 core symptom items (nausea, early satiety,<br /><br>postprandial fullness, upper abdominal pain, number of vomiting episodes)<br /><br>divided by 5.</p><br>
- Secondary Outcome Measures
Name Time Method