NCT00818493已完成2 期
An Open-Label Pilot Study of the Analgesic Efficacy and Safety Of Q8003 and of the Conversion From IV Morphine PCA Analgesia to Q8003 or to Percocet® in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty or Total Hip Arthroplasty
QRxPharma Inc.4 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2009年2月最近更新:
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
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Difference in pain intensity scores from baseline
研究概览
简要总结
This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
详细描述
This Phase 2 study is a 3 arm, open-label pilot study to evaluate:
- the analgesic efficacy of a flexible ascending regimen of Q8003 compared to a low dose regimen of Q8003 (3 mg/2 mg and potentially up to 6 mg/ 4mg) and to 1-2 Percocet® 5 mg/325 mg tablets. Study drug will be administered every 4-6 hours over a 48-hour Treatment Period to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
- for the flexible ascending regimen of Q8003 treatment group, to evaluate the adequacy of the algorithm for conversion of IV PCA morphine to oral morphine equivalent doses of Q8003.
- the safety of the flexible ascending regimen of Q8003 administered over a 48-hour Treatment Period.
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
- None
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
- •Male of female, at least 18 years of age at time of enrollment.
- •If female, be at least one year post-menopausal, surgically sterile or practicing effective contraception, 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 or total hip arthroplasty performed 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 or 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.
研究组 & 干预措施
1
Experimental
Q8003, flexible ascending dose
干预措施: Q8003 (morphine sulfate and oxycodone hydrochloride) (Drug)
2
Experimental
Low dose Q8003
干预措施: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) (Drug)
3
Active Comparator
Percocet (oxycodone and acetaminophen)
干预措施: Percocet (oxycodone and acetaminophen) (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(Throughout the 48 hour period)
研究者
研究点 (4)
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