NCT01435577已完成2 期
A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Differences (SPID 24)
研究概览
简要总结
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo primary unilateral first metatarsal bunionectomy
- •Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
- •Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).
排除标准
- •History of malignancy within the past 2 years
- •Current or history of alcohol or drug abuse.
- •Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
- •History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
- •Severely impaired renal function
- •Moderately or severely impaired hepatic function
- •Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
- •Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication
研究组 & 干预措施
Tapentadol intravenous
Experimental
Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
干预措施: Tapentadol (Drug)
Matching placebo intravenous
Placebo Comparator
Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Sum of Pain Intensity Differences (SPID 24)
时间窗: Baseline value; up to 24 hours after first study drug administration
Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline.
次要结局
- Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores(Baseline value to 24 hours after first study drug administration)
- Pharmacokinetic Concentrations of Tapentadol-O-glucuronide(15 minutes to 20 hours after first drug administration)
- Sum of Pain Intensity Differences After 12 Hours(Baseline value to 12 hours after first study drug administration)
- Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores(Baseline value to 24 hours after first study drug administration)
- Mean Pain Intensity Scores at Fixed Time Points(Baseline; up to 48 hours)
- Patients Global Impression of Change After 24 Hours of Treatment(Baseline value to 24 hours after study drug administration)
- Patient Global Impression of Change After 48 Hours of Treatment(Baseline value to 48 hours after first study drug administration)
- Sum of Pain Intensity Differences After 4 Hours(Baseline value to 4 hours after first study drug intake)
- Sum of Pain Intensity Differences After 8 Hours(Baseline value to 8 hours after first study drug administration)
- Pain Intensity Differences at Fixed Time Points(Starting at 15 minutes and up to 48 hours after first drug administration)
- Sum of Pain Intensity Differences After 60 Minutes(Baseline value to 60 minutes after first study drug administration)
- Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores(Baseline value to 12 hours after first study drug administration)
- Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores(Baseline value to 48 hours after first study drug administration)
- Patient Global Impression of Change After 12 Hours of Treatment(Baseline value to 12 hours after first study drug administration)
- Sum of Pain Intensity Differences After 48 Hours(Baseline value to 48 hours after first study drug administration)
- Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores(Baseline value to 12 hours after first study drug administration)
- Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores(Baseline value to 48 hours after first study drug administration)
- Time to First Rescue Medication(up to 48 hours)
- Time to Meaningful Pain Relief(up to 48 hours)
- Time to Perceptible Pain Relief(up to 48 hours)
- Pharmacokinetic Concentrations of Tapentadol(15 minutes to 20 hours after first drug administration)
- Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants(Baseline; for the first 6 administrations)
- Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants(Baseline; for the first 6 administrations)
研究者
研究点 (1)
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