A Double-blind, Placebo Controlled, Randomized, Two Centre Phase IIA Pharmacodynamic Cross-over Study to Assess the Effect of AZD3355, 65 mg Bid, on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in GERD Patients With an Incomplete Response to PPI Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 主要终点
- Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose
研究概览
简要总结
The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written consent
- •GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
- •6 months history of GERD and incomplete response to PPI treatment
排除标准
- •Insufficient symptom burden of the reflux disease evaluated by questionnaires
- •S-creatinine >1.2 times upper limit of normal
- •History of heart disease
- •Prior surgery of the upper GI tract
研究组 & 干预措施
1
AZD3355
干预措施: AZD3355 (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose
时间窗: 0-3 hours post meal, post third dose
The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133). The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment.
次要结局
- Total Number Reflux Episodes 0-24 Hours Post First Dose(0-24 hours)
- Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.(0-12 hours post first dose)