A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taking Low Dose Aspirin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,045
- 主要终点
- Gastroduodenal ulcers at final visit
研究概览
简要总结
The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
详细描述
This study was designed to compare the effectiveness of reducing the incidence of gastroduodenal ulcers between lansoprazole 30mg QD + naproxen 500mg BID vs celecoxib 200mg QD in subjects with osteoarthritis taking low dose aspirin. Approximately 100 sites across the U.S. will enroll subjects with normal endoscopic findings and negative H.pylori. The duration of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and a 12 week treatment period. Gelusil will be provided for dyspepsia symptom rescue.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
- •Must be taking daily aspirin for cardiovascular prophylaxis.
- •Clinical Laboratory values within normal limits for this population
排除标准
- •History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
- •Evidence of uncontrolled, clinically significant disease.
- •History of cancer within the past 5 years.
- •Presence of gastroduodenal ulcers, esophageal ulcer or >= 10 gastroduodenal erosions during the screening endoscopy. Known history of gastroduodenal ulcer or bleeding within the past year. Esophageal stricture requiring dilatation.
- •Presence of Barrett's esophagus with dysplastic changes.
- •Systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
- •Sero-tests positive for H. pylori.
- •Evidence of Zollinger-Ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
- •Requires treatment with an excluded medication such as proton pump inhibitors, histamine H2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, St. John's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.
研究组 & 干预措施
Lansoprazole 30 mg QD + Naproxen 500 mg BID
(and added aspirin)
干预措施: Lansoprazole and naproxen and aspirin (Drug)
Celecoxib 200 mg QD
(and added aspirin)
干预措施: Celecoxib and aspirin (Drug)
结局指标
主要结局
Gastroduodenal ulcers at final visit
时间窗: Week 12
次要结局
- Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)(Week 12)
- Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.(Weeks 4,8, and 12)
- Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline.(Weeks 4,8, and 12)
- Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.(Weeks 4, 8, and 12)
- Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.(Weeks 4, 8, and 12)
- The change from baseline SODA scale for subjects with dyspepsia at baseline.(Weeks 4, 8, and 12)