NCT01559701已完成3 期
A Long-Term, Open-Label, Safety Study Of PTI-821 In Patients With Moderate To Severe Chronic Low Back Pain Or With Moderate To Severe Chronic Pain Due To Osteoarthritis Of The Hip Or Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 823
- 主要终点
- Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis
详细描述
This study will evaluate: (a) the long-term safety of PTI-821 during a 12-month period; and (b) the long-term efficacy of PTI-821 by assessing pain intensity (PI), the quality of analgesia, and the global assessment of study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the Baseline Visit or persistent moderate to severe low back pain for at least six months while regularly taking one or more of the following types of oral analgesic medication(s) prior to the Baseline Visit.
- •Patient agrees to refrain from taking any opioid medications other than study drug during the study period. Patients must agree to report all non-opioid analgesic medications taken.
- •Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or IUD). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at the Baseline Visit.
排除标准
- •Patient has a positive urine drug screen at the Baseline Visit.
- •Patient currently is on an opioid regimen with a daily opioid dose equivalent of oxycodone > 160 mg.
- •Patient has major surgery planned during the proposed study period.
研究组 & 干预措施
PF-00345439 (oxycodone)
Experimental
PF-00345439 (oxycodone)
干预措施: PF-00345439 (Drug)
结局指标
主要结局
Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 12 months
次要结局
- Percent change from baseline Pain Intensity Scale(baseline 1, 3, 6, 9 and 12 months)
- Quality of Analgesia - patient reported outcome of analgesia quality using ratings of excellent, very good, good, fair, or poor.(1, 3, 6, 9 and 12 months)
- Global Assessment of Study Medication - patient reported outcome using ratings of excellent, very good, good, fair, or poor.(1, 3, 6, 9 and 12 months)
研究者
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