Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 661
- 试验地点
- 1
- 主要终点
- Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)
研究概览
简要总结
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
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
- Double (Participant, Investigator)
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 informed consent prior to any study specific procedures
- •Have at least 6 months history of GERD
- •Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication
排除标准
- •Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- •Prior surgery of the upper gastrointestinal tract.
- •Subject who have any of the following conditions or diseases: Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
研究组 & 干预措施
60 mg
PPI+lesogaberan (AZD3355) 60 mg bid
干预措施: lesogaberan (AZD3355) (Drug)
120 mg
PPI+lesogaberan (AZD3355) 120 mg bid
干预措施: lesogaberan (AZD3355) (Drug)
180 mg
PPI+lesogaberan (AZD3355) 180 mg bid
干预措施: lesogaberan (AZD3355) (Drug)
240 mg
PPI+lesogaberan (AZD3355) 240 mg bid
干预措施: lesogaberan (AZD3355) (Drug)
Placebo
PPI+ Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)
时间窗: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease)
次要结局
- Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.(The 7 days before randomisation (baseline) and during 26-30 days of treatment)