NCT00743587已完成1 期
A Randomized, Double-Blind, Placebo And Active Controlled Methodology Study Investigating The Effects Of Tramadol And Naproxen On The Pain Thresholds Of Patients With Severe Pain Due To Osteoarthritis Of The Thumb
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pressure pain threshold - area under the curve
研究概览
简要总结
The purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. The study will use agents known to give pain relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and oxycodone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, 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
- •The clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
- •Pain around one of the thumb joints due to osteoarthritis. The patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
- •The patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kPa.
排除标准
- •Pregnant (as judged by a urine pregnancy test) or lactating female.
- •Other severe pain which may impair the assessment of the pain due to osteoarthritis.
- •Skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
- •Known hypersensitivity to oxycodone, NSAIDS or tramadol.
- •Patients in whom NSAIDS, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
- •An estimated renal clearance of less than 30 mL/min based on the Cockcroft Gault equation.
- •Use of prohibited medications as listed below, in the absence of appropriate washout periods:
- •Oral or intramuscular corticosteroids within 4 weeks prior to screening.
- •Monoamine oxidase inhibitors within 2 weeks of screening.
- •Analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (Aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted)
- •Acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds.
- •Intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening.
- •History of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
研究组 & 干预措施
A
Placebo Comparator
干预措施: Placebo (Drug)
B
Active Comparator
干预措施: Oxycodone (Drug)
C
Active Comparator
干预措施: Tramadol (Drug)
D
Active Comparator
干预措施: Naproxen (Drug)
结局指标
主要结局
Pressure pain threshold - area under the curve
时间窗: 0 to 4 hours
次要结局
- Present pain intensities - at specific time points(0 to 12 hours)
- Pressure pain threshold - at specific time points(0 to 12 hours)
研究者
研究点 (1)
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