Pilot Study of OXP005 to Assess Gastroduodenal Irritation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Severity of GD irritation in the stomach and duodenum as measured by the Lanza score
研究概览
简要总结
Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at the relative impact of both products on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject
- •Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum)
- •H. pylori negative
排除标准
- •Clinically significant abnormal laboratory parameters
- •Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, centralcnervous, immunological, dermatological, GI or any other body system
研究组 & 干预措施
OXP005
1g naproxen
干预措施: OXP005 (Drug)
naproxen
1g naproxen
干预措施: Naproxen (Drug)
结局指标
主要结局
Severity of GD irritation in the stomach and duodenum as measured by the Lanza score
时间窗: Day 8
Total number of GD erosions overall
时间窗: Day 8
次要结局
未报告次要终点