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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Naronapride is a 5HT-4 agonist
Placebo
Dr Falk Investigational Site
Chula Vista, California, United States
Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12
Time frame: 12 weeks
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