NCT00366444已完成3 期
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Xanodyne Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2006年8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
- 201
- 试验地点
- 1
- 主要终点
- Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
研究概览
简要总结
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with 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
- Double
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
- •18-65 years of age
- •Have undergone bunionectomy surgery
- •Have achieved adequate post-surgical pain
排除标准
- •Confounding medical conditions which preclude study participation
- •Participated in a study of another investigational drug or device within 30 days prior to randomization
研究组 & 干预措施
1
Experimental
干预措施: diclofenac potassium (XP21L) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
时间窗: Over 48 hours after bunionectomy
Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
次要结局
- Number of Patients With Perceptible Pain Relief on Day 1(8 hours post single dose)
- Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1(8 hours post single dose)
- Number of Patients With Meaningful Pain Relief on Day 1(8 hours post single dose)
- Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1(8 hours post single dose)
- Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug(8 hours post single dose)
- Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug(8 hours post single dose)
- Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug(8 hours post single dose)
- Number of Patients Who Required Rescue Medication on Day 1(Day 1)
- Number of Patients Who Required Rescue Medication on Day 2(Day 2)
- Number of Patients Who Required Rescue Medication on Day 3(Day 3)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy SurgeryPain, PostoperativeNCT00375934Xanodyne Pharmaceuticals200
已完成
3 期
Efficacy of XP20B Following Bunionectomy SurgeryAcute PainNCT00655291Xanodyne Pharmaceuticals190
已完成
2 期
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth ExtractionDental PainNCT00954356Xenon Pharmaceuticals Inc.61
已完成
1 期
Central Pain Study for ABX-1431Neuromyelitis Optica Spectrum DisorderTransverse MyelitisLongitudinally Extensive Transverse MyelitisMultiple SclerosisNCT03138421Abide Therapeutics9
终止
4 期
Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast ReconstructionMammaplastyNCT02662036Washington University School of Medicine70