MOVE-IT: Different Doses of Naronapride vs. Placebo in Gastroparesis
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Naronapride 10 mg
|
Drug: Naronapride
Naronapride is a 5HT-4 agonist
|
Experimental: Naronapride 20 mg
|
Drug: Naronapride
Naronapride is a 5HT-4 agonist
|
Experimental: Naronapride 40 mg
|
Drug: Naronapride
Naronapride is a 5HT-4 agonist
|
Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12 [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women between ≥18 and ≤75 years of age
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History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥3 months
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Evidence of delayed gastric emptying
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Average weekly total symptom score of ≥2.0
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Body Mass Index ≥16 and <35 kg/m2
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Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique
Exclusion Criteria:
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Participants without access to an internet-capable terminal and/or without an own e-mail address
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History of major gastrointestinal surgery
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Intrapyloric botulinum toxin injection within 12 months
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Gastric stimulator implant
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Known secondary causes of gastroparesis
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Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Dr. Falk Pharma GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NAT-19/GPX