A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 2
- 主要终点
- The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)
研究概览
简要总结
The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
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, Investigator, Outcomes Assessor)
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
- •Patient is male or female between 18 and 65 years of age
- •For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
- •Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
- •Patient must be willing to stay at the study site ≥ 72 hours
排除标准
- •Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
- •Patient has a current disease or history of a disease that will impact the study or the patient's well-being
- •Patient has used or intends to use any of the medications that are prohibited by the protocol
- •Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
- •Patient has taken another investigational drug within 30 days prior to screening
研究组 & 干预措施
Indomethacin 40 mg TID
干预措施: Indomethacin (Drug)
Indomethacin 40 mg BID
干预措施: Indomethacin (Drug)
Placebo
干预措施: Placebo (Drug)
Indomethacin 20 mg TID
干预措施: Indomethacin (Drug)
结局指标
主要结局
The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)
时间窗: 0-48 hours
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.
次要结局
- TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours(0-24 hours)
- TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours(0-48 hours)
- VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.(0-8 hours)
- VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.(0-4 hours)
- TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours(0-8 hours)
- VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.(0-24 hours)
- Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).(0-4 hours)