A Multicenter, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 64
Updated:	11/23/2013
Start Date:	December 2012
End Date:	February 2014

A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

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.

Inclusion Criteria:

- Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper
abdominal pain, retching or vomiting) for at least 3 months prior to Screening

- Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive

- Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening

- Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) > 160
minutes as determined by [13C]-octanoate breath test, at Screening

- Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging
reasonably proximal to the diagnosis of gastroparesis

Exclusion Criteria:

- Acute severe gastroenteritis within 2 weeks prior to Screening

- History of gastric outlet obstruction

- Prior history of gastric surgery, including but not limited to gastrectomy, gastric
bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication

- Recurrent vomiting, defined as vomiting more than 2 days per week

- Hospitalization for treatment of gastroparesis or complications of diabetes within 4
weeks prior to Screening

- Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal
thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening

- If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >10% or a
glucose > 250 mg/dL at Screening

We found this trial at

sites

Indiana University Hospital

550 University Boulevard
Indianapolis, Indiana 46202

from

Indianapolis, IN