Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

Gastroparesis Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718938
• Other study ID #: 0093
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2012
• Last updated: February 22, 2018
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2018
• Source: Theravance Biopharma R & D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• velusetrag dose 1

• velusetrag dose 2

• velusetrag dose 3

• placebo

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana
United States	GI Associates & Endoscopy Center	Jackson	Mississippi
United States	Axis Clinical Trials	Los Angeles	California
United States	Center for Digestive and Liver Diseases, Inc.	Mexico	Missouri
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Northwest Gastroenterology Clinic	Portland	Oregon
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Desert Sun Clinical Research	Tucson	Arizona
United States	Ventura Clinical Trials	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
Theravance Biopharma R & D, Inc.	Alfasigma S.p.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying half time (GE t1/2)		From baseline to week 5
Secondary	Duration of lag time to gastric emptying (tlag)		From baseline to Week 5
Secondary	Vital signs	Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis	From baseline to Day 49
Secondary	ECGs		From baseline to Day 49
Secondary	Number of adverse events		From baseline to Day 49