NCT01664637终止2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis
Tranzyme, Inc.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline in symptoms associated with diabetic gastroparesis
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age inclusive
- •Type 1 or type 2 diabetes mellitus
- •History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
- •Documented delayed gastric emptying
- •Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
- •Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.
- •Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception
排除标准
- •Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
- •Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study
- •NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit
- •Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit
- •Active gastric pacemaker within 3 months prior to the Screening Visit
研究组 & 干预措施
TZP-102 three times a day
Experimental
10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
干预措施: 10 mg TZP-102 (Drug)
Placebo three times a day
Placebo Comparator
Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in symptoms associated with diabetic gastroparesis
时间窗: 12 Weeks
次要结局
- Change from baseline in health-related quality of life(12 Weeks)
- Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters(12 Weeks)
研究者
研究点 (1)
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