This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis. Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Desert Sun Clinical Research
Tucson, Arizona, United States
Axis Clinical Trials
Los Angeles, California, United States
Ventura Clinical Trials
Ventura, California, United States
Indiana University Hospital
Gastric emptying half time (GE t1/2)
Time frame: From baseline to week 5
Duration of lag time to gastric emptying (tlag)
Time frame: From baseline to Week 5
Vital signs
Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis
Time frame: From baseline to Day 49
ECGs
Time frame: From baseline to Day 49
Number of adverse events
Time frame: From baseline to Day 49
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indianapolis, Indiana, United States
GI Associates & Endoscopy Center
Jackson, Mississippi, United States
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Northwest Gastroenterology Clinic
Portland, Oregon, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States