NCT00889486已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus
Tranzyme, Inc.23 个研究点 分布在 6 个国家目标入组 92 人开始时间: 2009年4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
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 23
- 主要终点
- change from baseline in gastric half-emptying time
研究概览
简要总结
The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients 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
- Triple (Participant, Care Provider, Investigator)
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.
- •Female patients of childbearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable method of contraception.
- •HbA1c level less than/equal to 10.0 % at the Screening Visit.
- •Diagnosis of gastroparesis including (all three of the following requirements apply): i. Documented delayed gastric emptying; ii. A greater than 3 month history of symptoms of gastroparesis; iii. A GCSI Total Score greater than/equal to 2.66 at the Screening Visit and greater than/equal to 1.90 at the Day 1 visit.
- •Upper gastrointestinal obstruction ruled out by endoscopy or barium scan.
- •Concomitant medications must be stable for at least 2 weeks leading up to the Baseline Visit and be maintained during the study.
- •Body Mass Index (BMI) <
- •Delayed gastric emptying by breath test demonstrated at the Baseline Visit.
排除标准
- •Persistent daily vomiting
- •Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloroplasty.
- •Pyloric Botox within 6 months prior to Screening Visit.
- •NG, PEG or PEJ feeding tube.
- •Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit.
- •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.
- •Participation in an investigational study within 30 days prior to study entry.
- •Chronic severe diarrhea.
- •Diabetic ketoacidosis requiring hospitalization within 30 days prior to study entry.
- •History of any eating disorder within 2 years prior to study entry.
- •Significant chronic obstructive pulmonary disease or chronic asthma.
- •Patient is a heavy smoker, and/or unable or unwilling to abstain from smoking during each of the three study visits during which the gastric emptying breath tests will be performed.
- •History of risk factors for Torsades de Pointes.
- •Patient requires treatment with certain concomitant medications known to have a clinically recognized risk for Torsades de Pointes.
- •History of acute myocardial infarction (MI) or unstable angina within 12 months prior to study entry.
- •History of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
- •History of alcohol dependency within 2 years prior to study entry.
- •Taking opiates for abdominal pain.
- •History of HIV infection.
- •History of Hepatitis B or C currently exhibiting symptoms expected to worsen during course of study.
- •Requires dialysis or has severely impaired renal function.
- •Severe impairment of liver function.
- •Uncontrolled hypo- or hyperthyroidism.
- •History of adrenal insufficiency.
- •Pregnant or is breast-feeding.
- •Allergic to or intolerant of wheat, egg, soy or milk products.
- •Patient requires a gluten-free diet.
- •Any other medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Four placebo capsules taken orally once per day for 28 days
干预措施: Placebo (Drug)
10 mg TZP-102
Experimental
One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days
干预措施: TZP-102 (Drug)
10 mg TZP-102
Experimental
One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days
干预措施: Placebo (Drug)
20 mg TZP-102
Experimental
Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days
干预措施: TZP-102 (Drug)
20 mg TZP-102
Experimental
Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days
干预措施: Placebo (Drug)
40 mg TZP-102
Experimental
Four 10 mg TZP-102 Capsules taken orally once per day for 28 days
干预措施: TZP-102 (Drug)
结局指标
主要结局
change from baseline in gastric half-emptying time
时间窗: study days 1 and 28
次要结局
- change from baseline in gastroparesis symptoms and health-related quality of life(study days 8, 15 and 28)
研究者
研究点 (23)
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