A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 9
- 主要终点
- Gastric emptying half time (GE t1/2)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sequence 1
3-way crossover of velusetrag or placebo
干预措施: placebo (Drug)
Sequence 2
3-way crossover of velusetrag or placebo
干预措施: placebo (Drug)
Sequence 1
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 1 (Drug)
Sequence 1
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 2 (Drug)
Sequence 1
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 3 (Drug)
Sequence 2
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 1 (Drug)
Sequence 2
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 2 (Drug)
Sequence 2
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 3 (Drug)
Sequence 3
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 1 (Drug)
Sequence 3
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 2 (Drug)
Sequence 3
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 3 (Drug)
Sequence 3
3-way crossover of velusetrag or placebo
干预措施: placebo (Drug)
Sequence 4
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 1 (Drug)
Sequence 4
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 2 (Drug)
Sequence 4
3-way crossover of velusetrag or placebo
干预措施: velusetrag dose 3 (Drug)
Sequence 4
3-way crossover of velusetrag or placebo
干预措施: placebo (Drug)
结局指标
主要结局
Gastric emptying half time (GE t1/2)
时间窗: From baseline to week 5
次要结局
- 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)