NCT01366014已完成2 期
A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee).
研究概览
简要总结
This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Approximately 150 patients from the US will be enrolled in this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year).
- •At least moderate or severe pain due to OA in one knee.
- •On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study.
- •Discontinuation of opioids prior to study start.
- •Additional criteria exist.
排除标准
- •Current or recent infection in the last 7 days; infection requiring hospitalization or parenteral antibiotics within the last 6 months; history of or currently active tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).
- •Surgery on the index knee within the previous 6 months.
- •Trauma or other surgeries within the previous 8 weeks.
- •Specific abnormal laboratory values or electrocardiogram abnormalities.
- •Gastrointestinal surgery that may interfere with motility or absorption.
- •On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone (PTH) therapies.
- •Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor (NGF) therapies.
- •Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks.
- •Intra-articular corticosteroids in the index knee within the previous 8 weeks or viscosupplementation in the index knee within the previous 4 months.
- •Currently enrolled in or participated in another clinical trial within the previous 3 months.
- •Additional criteria exist.
研究组 & 干预措施
ARRY-371797
Experimental
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
Oxycodone HCl ER
Active Comparator
干预措施: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral (Drug)
Placebo
Placebo Comparator
干预措施: Placebo; oral (Drug)
结局指标
主要结局
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee).
时间窗: 4 weeks
次要结局
- Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.(4 weeks)
- Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the WOMAC stiffness and physical function subscale scores (index knee).(4 weeks)
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.(5 weeks)
研究者
研究点 (1)
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