Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis
Completed · Phase 2 · Has a placebo group
Conditions studied: Gastroparesis
In brief
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.
Key facts
- Study ID
- NCT01718938
- Run by
- Theravance Biopharma
- People needed
- 34
- Starts
- 2012-12-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2018-02-26
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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 — 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
Full record on ClinicalTrials.gov
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