NCT02267525已完成2 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 主要终点
- 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score
研究概览
简要总结
Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
- •Composite score ≥2and <5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening
- •Delayed gastric emptying by either GES (gastric emptying scintigraphy) or GEBT(gastric emptying breath test)
- •Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms
- •Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during Screening, if applicable; 24 hours prior to start of the Baseline period; and during the Baseline Period
- •GCSI-24H 7-day mean composite score ≥2.5 and <5 at Day 1
排除标准
- •If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >11%
- •Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach
- •History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator
- •History of alcohol or drug abuse or dependence within the last year prior to Screening
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo capsules QD x 12 weeks
干预措施: Placebo (Drug)
Velusetrag 5mg
Experimental
Velusetrag 5mg capsules QD (once daily) x 12 weeks
干预措施: Velusetrag (Drug)
Velusetrag 15mg
Experimental
Velusetrag 15mg capsules QD x 12 weeks
干预措施: Velusetrag (Drug)
Velusetrag 30mg
Experimental
Velusetrag 30mg capsules QD x 12 weeks
干预措施: Velusetrag (Drug)
结局指标
主要结局
7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score
时间窗: At Week 4
次要结局
- Gastric emptying half-time(At Week 4)
- Adverse events(103 days)
研究者
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