NCT00831051已完成2 期
A Double-Blind, Randomized, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of the Opioid Combination Q8003 to Each of the Individual Milligram Components (Oxycodone and Morphine) in the Management of Acute Moderate to Severe Pain Following Bunionectomy Surgery
QRxPharma Inc.6 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2008年12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
- 197
- 试验地点
- 6
- 主要终点
- Difference in pain intensity scores from baseline
研究概览
简要总结
This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient is male or female and at least 18 years of age.
- •Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment.
- •Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
- •To be randomized after surgery, the patient must report 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).
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).
研究组 & 干预措施
Morphine sulfate 12 mg
Active Comparator
Single component
干预措施: Morphine sulfate (Drug)
Oxycodone HCl 8mg
Active Comparator
Single component
干预措施: Oxycodone HCl (Drug)
Q8003 12mg/8mg
Experimental
Combination
干预措施: Q8003 (Drug)
Q8003 6mg/4mg
Experimental
Combination
干预措施: Q8003 (Drug)
Morphine sulfate 6mg
Active Comparator
Single component
干预措施: Morphine sulfate (Drug)
Oxycodone HCl 4mg
Active Comparator
Single component
干预措施: Oxycodone HCl 4mg (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(48 hours)
研究者
研究点 (6)
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