NCT00543465终止2 期
12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
研究概览
简要总结
This study will look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone.
This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study
- •Osteoarthritis (OA): must have diagnosis of OA in knee, hip, hand or spine
- •Patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to Visit 2 for any medical condition
- •Must be willing to limit alcohol use to no more than 2 drinks per day
- •Avoid strenuous physical activity
排除标准
- •Mentally or legally incapacitated
- •Has systemic lupus erythematosus, Paget's disease
- •Has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any GI surgery that causes clinical malabsorption or delayed gastric emptying
- •Has uncontrolled hypertension
- •Has uncontrolled diabetes
- •Has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months
- •Has congestive heart failure
- •Has had active liver disease within the last 2 years
研究者
相似试验
撤回
不适用
Do Nanobubbles Improve Joint Hypoxia?Psoriatic ArthritisRheumatoid ArthritisNCT04844008University of Oxford
已完成
3 期
Toward Better Outcomes in OsteoarthritisOsteoarthritisNCT00000425Stanford University900
已完成
1 期
A Pilot Study of FOLFIRINOX in Combination With Neoadjuvant Radiation for Gastric and GE Junction CancersGastroEsophageal CancerNCT03279237Massachusetts General Hospital25
已完成
3 期
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.Rheumatoid ArthritisOsteoarthritisAnkylosing SpondylitisNCT00367211POZEN400
已完成
3 期
Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)OsteoarthritisNCT00542087Organon and Co516