NCT00928837已完成不适用
A Double-Blind,Randomized, Placebo Controlled, Parallel Group, Multi-Center Study of Flavocoxid (Limbrel) Versuss Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
研究概览
简要总结
The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.
详细描述
To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major inclusión criteria:
- •Adults of either gender, ages 35-85, in general good health
- •Diagnosed with OA of the knee, K-L Grade 2-3
- •History of positive response to NSAID's or COX-2 inhibitors
- •Able and willing to discontinue other medicinal OA therapies for length of the study (subjects may continue low dose aspirin for cardioprotection)
- •Females of child bearing potential must use acceptable method of birth control
- •Major exclusion criteria:
- •Unwilling or unable to read and sign informed consent document
- •Pregnant and nursing women
- •History of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year
- •K-L grade 1 or 4 OA of the target knee
- •chronic bleeding disorder or present use of anticoagulants
- •History of upper G-I bleed in the past 5 years
- •Significant renal disease including nephrotic syndrome, proteinuria >1 gm/24 hrs or serum Creatinine >2.0
- •Any arthritic disease that is or has the potential to affect the knees during the course of the study
- •Any other condition that might confound evaluation of the target joint including, but not limited to, bursitis, tendonitis or internal derangement in or about the knee, gait disturbances (e.g. mechanical, neurological conditions or disorders of the back), fibromyalgia, polyneuropathies, etc.
排除标准
- 未提供
研究组 & 干预措施
flavocoxid 250 mg
Active Comparator
Medical Food product
干预措施: flavocoxid 250 mg (Other)
Naproxen
Active Comparator
antiinflammatory
干预措施: Naproxen (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
flavocoxid 500 mg
Experimental
medical food product
干预措施: Flavocoxid 500 mg (Dietary Supplement)
结局指标
主要结局
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
时间窗: 3 months
comparison of short WOMAC and timed walk
to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
时间窗: 3 months
Comparison of FS-36, subject tolerability VAS
次要结局
- to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks(6 months)
- to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks(6 months)
研究者
研究点 (1)
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