A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
2012年8月8日 更新者：Janssen Research & Development, LLC
A Double-Blind, Randomized, Placebo-and Active-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Subjects With Osteoarthritis
The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335 and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis patients.
This study will also assess the effectiveness of JNJ-39439335 on pain.
研究概览
详细说明
This will be a double-blind (patient and study staff will not know the identity of assigned treatment), randomized (assignment to 1 to 3 treatment groups will be by chance, like "flipping a coin"), placebo-controlled, multiple dose study conducted at up to two clinical sites.
Up to 42 patients with osteoarthritis of the knee will be enrolled in 3 cohorts (Cohort 1 to 3).
Additional cohorts (up to 14 patients per cohort) may be added after completion of Cohort 3. The study consists of eligibility screening, a treatment phase, and 4 follow-up visits.
The study duration for each patient will be approximately 10 weeks.
Patients safety will be closely monitored during the study by review of adverse events, electrocardiograms, vital signs (including oral temperature), clinical laboratory tests, and physical examinations.
During specified study visits, blood samples will be collected for pharmacokinetics, pharmacodynamics (inpatient patients), and pharmacogenomic (optional) evaluations of JNJ-39439335.
The effectiveness of JNJ-39439335 will be evaluated by assessing pain using an 11-point numerical rating scale and by the Western Ontario and McMaster Osteoarthritis Index.
In Cohort 1 and 2, all patients will take their study medication orally, twice a day for 21 days.
The treatment groups for Cohort 1 are JNJ-39439335 10 mg, naproxen 500 mg every 12 hours, and placebo.
The treatment groups for Cohort 2 are JNJ-39439335 25 mg, naproxen 500 mg every 12 hours, and placebo.
The treatment groups for Cohort 3 will be determined based on the results of Cohort 1 and 2.
研究类型
介入性
注册 (实际的)
43
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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George、南非
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Nonsmoker >= 6 months prior to first dose
- body mass index (BMI) <= 36 kg/m2
- Meet American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of knee by meeting at least 3 of the following: age > 50, morning stiffness < 30 minutes, crepitus on active motion, bony tenderness, bony enlargement, no palpable warmth of synovium
- Has Functional Class I-III osteoarthritis (OA) of knee with continuing OA-knee joint pain >= 5 days/week x 3 months prior to screening, and has been taking a non-opioid analgesic for OA knee pain daily for >=5 days prior to screening with benefit
- Otherwise healthy based on physical exam, medical history, vital signs, 12-lead electrocardiogram (ECG), can clinical laboratory tests
- Women must be postmenopausal or surgically sterile.
Exclusion Criteria:
- Oral temperature >37.5 deg C at Screening or Day -1
- Failure of burn prevention measures quiz at Screening
- patients with occupations or hobbies in which they are routinely exposed to situations in which they could sustain burns
- orthopedic and/or prosthetic device on target knee joint
- Significant pain outside the target knee, including significant hip or back pain (bilateral knee OA is permitted)
- Unable to discontinue prior analgesic medications/non-steroidal antiinflammatory drugs (NSAIDS) other than paracetamol during the study
- Surgical intervention for any pain within 3 months prior to screening or has plans for surgical intervention while in the study
- History of prior diagnosis of inflammatory arthritis (including rheumatoid arthritis)
- Treatment with local corticosteroid injections or viscosupplementation in target joint, or use of oral or intramuscular corticosteroids, within 3 months prior to Screening
- History of active peptic ulceration, active dyspepsia, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, chronic diarrhea esophageal, and gastric or duodenal ulcer within 3 months prior to screening or any other condition, which in the Investigator's opinion, precludes use of an NSAID.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：001
JNJ-39439335 2 x 5 mg tablets once daily for 21 days
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2 x 25 mg tablets once daily for 21 days
2 x 5 mg tablets once daily for 21 days
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实验性的：002
JNJ-39439335 2 x 25 mg tablets once daily for 21 days
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2 x 25 mg tablets once daily for 21 days
2 x 5 mg tablets once daily for 21 days
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其他：003
Naproxen 500 mg capsule every 12 hours for 21 days
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500 mg capsule every 12 hours for 21 days
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安慰剂比较：004
Placebo Placebo tablet/capsule every 12 hours for 21 days
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Placebo tablet/capsule every 12 hours for 21 days
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of participants with adverse events as a measure of safety and tolerability
大体时间：From screening up to final follow up visit.
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From screening up to final follow up visit.
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Change from baseline in vital signs, including oral body temperature
大体时间：From Day -1 up to final follow up visit
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From Day -1 up to final follow up visit
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Change from baseline in ECG
大体时间：From Day -1 up to final follow up visit
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From Day -1 up to final follow up visit
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Change from baseline in clinical laboratory tests
大体时间：From Day -1 up to final follow up visit
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From Day -1 up to final follow up visit
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Concentaton of JNJ-39439335 in blood and urine samples
大体时间：From Day 1 up to final follow up visit
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From Day 1 up to final follow up visit
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Concentration of JNJ-39439335 in blood and urine samples
大体时间：From Day 1 up to final follow up visit
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From Day 1 up to final follow up visit
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from baseline in pain numerical rating scale
大体时间：From Day 2 up to final follow up visit
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From Day 2 up to final follow up visit
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Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC)
大体时间：From Day -1 up to final follow up visit
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From Day -1 up to final follow up visit
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2011年4月7日
首先提交符合 QC 标准的
2011年4月26日
首次发布 (估计)
2011年4月28日
研究记录更新
最后更新发布 (估计)
2012年8月9日
上次提交的符合 QC 标准的更新
2012年8月8日
最后验证
2012年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.