Clinical trial NCT01718938: Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroparesis
Keywords: Gastroparesis
Diabetic
Idiopathic
Delayed gastric emptying
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
Collaborators: name: Alfasigma S.p.A.
First posted: 2012-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying half time (GE t1/2)
timeFrame: From baseline to week 5
Secondary outcomes:
measure: Duration of lag time to gastric emptying (tlag)
timeFrame: From baseline to Week 5
measure: Vital signs
timeFrame: From baseline to Day 49
measure: ECGs
timeFrame: From baseline to Day 49
measure: Number of adverse events
timeFrame: From baseline to Day 49
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Desert Sun Clinical Research
state: Arizona
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Jackson
country: United States
facility: GI Associates & Endoscopy Center
state: Mississippi
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases, Inc.
state: Missouri
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic
state: Oregon
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
Study officials:
References:
citation: 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.