Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis
A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis
1 other identifier
interventional
34
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2012
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 26, 2018
February 1, 2018
1 year
October 29, 2012
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastric emptying half time (GE t1/2)
From baseline to week 5
Secondary Outcomes (4)
Duration of lag time to gastric emptying (tlag)
From baseline to Week 5
Vital signs
From baseline to Day 49
ECGs
From baseline to Day 49
Number of adverse events
From baseline to Day 49
Study Arms (4)
Sequence 1
EXPERIMENTAL3-way crossover of velusetrag or placebo
Sequence 2
EXPERIMENTAL3-way crossover of velusetrag or placebo
Sequence 3
EXPERIMENTAL3-way crossover of velusetrag or placebo
Sequence 4
EXPERIMENTAL3-way crossover of velusetrag or placebo
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theravance Biopharmalead
- Alfasigma S.p.A.collaborator
Study Sites (9)
Desert Sun Clinical Research
Tucson, Arizona, 85710, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
GI Associates & Endoscopy Center
Jackson, Mississippi, 39202, United States
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, 65265, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Northwest Gastroenterology Clinic
Portland, Oregon, 97210, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Related Publications (1)
Kuo B, Barnes CN, Nguyen DD, Shaywitz D, Grimaldi M, Renzulli C, Canafax D, Parkman HP. Velusetrag accelerates gastric emptying in subjects with gastroparesis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 study. Aliment Pharmacol Ther. 2021 May;53(10):1090-1097. doi: 10.1111/apt.16344. Epub 2021 Apr 3.
PMID: 33811761DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2012
First Posted
November 1, 2012
Study Start
December 1, 2012
Primary Completion
December 1, 2013
Study Completion
February 1, 2014
Last Updated
February 26, 2018
Record last verified: 2018-02