NCT01055015已完成3 期
A Randomized, Double-Blind, Study of the Analgesic Efficacy and Safety of Flexible Dose Q8003 Versus Low Dose Q8003 in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty
QRxPharma Inc.1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Difference in pain intensity scores from baseline
研究概览
简要总结
This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty
详细描述
This Phase 3 study is a two-arm, double-blind study to:
- compare the analgesic efficacy and safety of the flexible regimen of Q8003 (6 mg/4 mg up to 24 mg/16 mg) administered every 4-6 hours over a 48-hour Treatment Period versus low dose Q8003 (every 4-6 hours 3 mg/2 mg with a 6 mg/4 mg loading dose) to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty.
- to evaluate the efficacy and safety of Q8003 when administered in the Voluntary Extension Period starting at 48 hours after the initial dosing and extending up to Day 12.
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
- 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
- •At least 18 years of age at time of enrollment.
- •If female, be at least one year post-menopausal, surgically sterile or practicing effective contraceptive, be non-lactating, and if of child-bearing potential, have a negative urine pregnancy test result.
- •Have a body mass index (BMI) of 38 kg/m2 or less.
- •Have undergone a primary unilateral total knee arthroplasty performed under under standardized general, spinal or epidural anesthesia.
- •Have developed moderate to severe pain (a score of 2 or more on the 4 point Likert scale and at least 4 on the 11 point NPRS scale within 6 hours of discontinuing PCA on the morning after surgery).
排除标准
- •In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
- •Used opiates continuously (including tramadol) for more than ten days in the past year.
- •Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
- •Currently receiving any medications that are not at a stable dose (the same dose for > 2 months prior to date of surgery).
- •Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q
- •Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
- •Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
- •History of abusing licit or illicit drug substances within five (5) years of study entry.
- •Has taken drugs known to interact with morphine or oxycodone metabolism, including, but not limited to, phenothiazines, monoamine oxidase inhibitors (MAOI), amphetamines, and muscle relaxants within the 4 weeks prior to the date of surgery.
- •History of sleep apnea.
研究组 & 干预措施
1
Experimental
Q8003, Flexible dose
干预措施: Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) (Drug)
2
Experimental
Q8003, Low dose
干预措施: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) (Drug)
结局指标
主要结局
Difference in pain intensity scores from baseline
时间窗: 48 hours
次要结局
- Safety: adverse events, opioid-related signs and symptoms(Throughout the 48-hour period and during the voluntary safety extension period.)
研究者
研究点 (1)
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