A 16-Day, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Trial Comparing Lumiracoxib 100mg o.d. With Naproxen 500 mg b.i.d. Plus Omeprazole 20mg o.d. and Placebo in Healthy Volunteers to Investigate on the Safety and Tolerability of Lumiracoxib in the Small Bowel.

Novartis2 个研究点分布在 2 个国家目标入组 150 人开始时间: 2006年5月1日最近更新: 2007年12月13日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 150
试验地点: 2
主要终点: Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to investigate the potential differences in GI safety and tolerability in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a proton pump inhibitor (omeprazole), or placebo.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Healthy male or female subjects

排除标准

•Evidence of cardiovascular, hepatic, gastrointestinal or renal disorders
•Hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption syndrome
•Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy

次要结局

Total number of small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
Percentage of subjects with one or more small bowel lesion detected by video capsule endoscopy
Total number of small bowel lesions detected by video capsule endoscopy
Value of small bowel inflammation (as measured by calprotectin test)
Value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars)

研究者

发起方

Novartis

申办方类型

Industry

研究点 (2)

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