Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,484
- 试验地点
- 1
- 主要终点
- Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
研究概览
简要总结
To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.
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, Care Provider, Investigator)
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
- •Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
- •Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit
排除标准
- •Active GD ulceration or GD ulceration within 90 days of the screening visit.
- •Concomitant use of low dose aspirin
- •Previous MI, stroke or significant vascular disease.
研究组 & 干预措施
A
干预措施: Celecoxib (Drug)
B
干预措施: Diclofenac + Omeprazole (Drug)
结局指标
主要结局
Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
时间窗: 6 month treatment duration
CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.
次要结局
- Number of Subjects Withdrawn Due to GI Adverse Events (AEs)(6 month treatment duration)
- Change From Baseline in Ferretin to Month 6/ET(Month 6/ET)
- Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET(Month 6/ET)
- Change From Baseline in Iron Binding Capacity to Month 6/ET(Month 6/ET)
- Number of Subjects With SUs(6 month treatment duration)
- Number of Subjects With CSULGIEs by History of GD Ulceration(6 month treatment duration)
- Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin(6 month treatment duration)
- Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)(6 month treatment duration)
- Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)(Month 6/Early Termination (ET))
- Change From Baseline in Hematocrit at Month 6/ET(Month 6/ET)
- Change From Baseline in C-Reactive Protein to Month 6/ET(Month 6/ET)
- Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)(6 month treatment duration)
- Number of Subjects With Moderate to Severe Abdominal Symptoms(6 month treatment duration)
- Change From Baseline in Hemoglobin at Month 6/ET(Month 6/ET)