Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

Phase 2

Completed

• Conditions: Gastroparesis
• Interventions: Drug: velusetrag dose 1; Drug: velusetrag dose 2; Drug: velusetrag dose 3; Drug: placebo

• Registration Number: NCT01718938
• Lead Sponsor: Theravance Biopharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-01
• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2018-02
• Disposition First Submitted: 2018-02-22
• Disposition First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Disposition First Posted: 2018-02-26
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 4	placebo	3-way crossover of velusetrag or placebo
Sequence 4	velusetrag dose 2	3-way crossover of velusetrag or placebo
Sequence 4	velusetrag dose 3	3-way crossover of velusetrag or placebo
Sequence 3	velusetrag dose 1	3-way crossover of velusetrag or placebo
Sequence 1	velusetrag dose 2	3-way crossover of velusetrag or placebo
Sequence 3	velusetrag dose 2	3-way crossover of velusetrag or placebo
Sequence 1	velusetrag dose 1	3-way crossover of velusetrag or placebo
Sequence 3	velusetrag dose 3	3-way crossover of velusetrag or placebo
Sequence 1	velusetrag dose 3	3-way crossover of velusetrag or placebo
Sequence 1	placebo	3-way crossover of velusetrag or placebo
Sequence 2	velusetrag dose 1	3-way crossover of velusetrag or placebo
Sequence 2	velusetrag dose 3	3-way crossover of velusetrag or placebo
Sequence 2	placebo	3-way crossover of velusetrag or placebo
Sequence 3	placebo	3-way crossover of velusetrag or placebo
Sequence 4	velusetrag dose 1	3-way crossover of velusetrag or placebo
Sequence 2	velusetrag dose 2	3-way crossover of velusetrag or placebo

Primary Outcome Measures

Name	Time	Method
Gastric emptying half time (GE t1/2)	From baseline to week 5

Secondary Outcome Measures

Name	Time	Method
Duration of lag time to gastric emptying (tlag)	From baseline to Week 5
ECGs	From baseline to Day 49
Number of adverse events	From baseline to Day 49
Vital signs	From baseline to Day 49	Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis

Trial Locations

Locations (9)

Wake Research Associates, LLC; 🇺🇸 Raleigh, North Carolina, United States

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States

GI Associates & Endoscopy Center; 🇺🇸 Jackson, Mississippi, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Desert Sun Clinical Research; 🇺🇸 Tucson, Arizona, United States

Ventura Clinical Trials; 🇺🇸 Ventura, California, United States

Digestive and Liver Disease Specialists; 🇺🇸 Norfolk, Virginia, United States

Northwest Gastroenterology Clinic; 🇺🇸 Portland, Oregon, United States

Center for Digestive and Liver Diseases, Inc.; 🇺🇸 Mexico, Missouri, United States