NCT00981357已完成2 期
A Phase 2a Randomized, Double-blinded, Double Dummy, Placebo And Active Controlled, Two-way Cross-over, Flare-enriched Multi-centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A Fatty Acid Amide Hydrolase (Faah) Inhibitor Pf-04457845 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
- 76
- 试验地点
- 6
- 主要终点
- To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee
研究概览
简要总结
Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
- •Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
- •Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant
排除标准
- •Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments
研究组 & 干预措施
PF-04457845 followed by placebo
Experimental
干预措施: PF-04457845 (Drug)
Placebo followed by PF-04457845
Experimental
干预措施: PF-04457845 (Drug)
Naproxen followed by placebo
Active Comparator
干预措施: Naproxen (Drug)
Placebo followed by Naproxen
Active Comparator
干预措施: Naproxen (Drug)
结局指标
主要结局
To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee
时间窗: 8 weeks
To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.
时间窗: 10 weeks
次要结局
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee.(8 weeks)
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee.(8 weeks)
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.(8 weeks)
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee.(8 weeks)
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Daily pain diary over weeks 1 and 2 of each treatment period using an 11-point Numeric Rating Scale (NRS) in patients with osteoarthritis of the knee.(8 weeks)
- Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment.(8 weeks)
- Summary of plasma concentrations of PF-04457845.(8 weeks)
- Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis.(8 weeks)
- Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis.(8 weeks)
研究者
研究点 (6)
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