Clinical study to show if Naronapride tablets are safe and efficient for treatment of delayed stomach emptying and to find the optimal dose.
- Conditions
- Idiopathic or Diabetic GastroparesisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-510195-31-00
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 318
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method