NCT00206245已完成2 期
A Randomised, Double-blind, Multicentre Dose-finding Phase IIb Study for up to 8 Weeks' Treatment With AZD0865 25, 50, 75 mg and Esomeprazole 40 mg, Given Orally Once Daily for the Healing of Erosive Esophagitis in Adult Subjects With GERD With Erosive Esophagitis According to the LA Classification in Adult Subjects.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,400
- 试验地点
- 202
- 主要终点
- Healing of erosive esophagitis at 4 weeks.
研究概览
简要总结
The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg).
The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.
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
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
- •Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone.
- •Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit
- •Erosive esophagitis according to LA classification Grade A, B, C or D, at the visit 1 endoscopy.
- •Have provided Informed consent.
排除标准
- •Subjects with current or historical evidence of the following conditions are excluded from the study:
- •Esophageal stricture.
- •Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
- •Systemic Sclerosis (scleroderma).
- •Irritable Bowel Syndrome (IBS), i.e. upper abdominal discomfort or pain that in the opinion of the Investigator is likely to be due to IBS or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools.
- •Inflammatory bowel disease.
- •Zollinger-Ellison syndrome.
- •Gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months
- •Subjects with i) history of significant or ii) current significant or unstable:
- •Cardiovascular diseases or cardiac chest pain.
- •Cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus.
- •Diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable.
- •Pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study.
- •Malignant disease (except for minor superficial skin disease).
- •Generalised bleeding disorders.
结局指标
主要结局
Healing of erosive esophagitis at 4 weeks.
次要结局
- Investigator-reported symptoms.
- Healing of erosive esophagitis at 2 and 8 weeks.
- The Quality of Life in Reflux and Dyspepsia (QOLRAD).
- Patient-reported symptoms.
- pH monitoring.
- Histology.
- Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
- Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).
研究者
研究点 (202)
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