NCT00468845已完成3 期
A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 501 人开始时间: 2007年6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
- 501
- 试验地点
- 1
- 主要终点
- Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
研究概览
简要总结
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
- •The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
- •The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.
排除标准
- •Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
- •Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
- •The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
- •Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
- •The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).
研究组 & 干预措施
1
Experimental
干预措施: pregabalin (Lyrica) (Drug)
2
Experimental
干预措施: pregabalin (Lyrica) (Drug)
3
Placebo Comparator
干预措施: matched placebo (Drug)
结局指标
主要结局
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
时间窗: Day 2 (24 hours post surgery [PS])
Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
次要结局
- Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test(Day 1, up to 7 days PS, 2 and 4 weeks PS)
- Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay(48 +/- 4 hours PS)
- Total Cumulative Dose of Opioids Following Surgery(24, 48 Hours PS, Discharge (day 3 up to day 7 PS))
- Anxiety Before and After Surgery(Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS))
- Time to Meet Hospital Discharge Criteria(Day 1 up to Day 7 PS)
- Current Pain at Rest(8, 16, 24, 32, 40, 48 hours PS)
- Average Daily Pain(Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS)
- Worst Daily Pain(Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS)
- Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores(Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS)
- Participant Satisfaction With Study Medication - Day 2 PS(Day 2 PS)
- Participant Satisfaction With Study Medication - Day 3 PS(Day 3 PS)
- Participant Satisfaction With Study Medication - Day 5 PS(Day 5 PS)
- Participant Satisfaction With Study Medication - Discharge(Discharge (day 3 up to day 7 PS))
- Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting(48 +/- 4 hours PS)
- Current Pain - Pain With Movement Caused by Sitting(Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS)
- Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test(48 +/- 4 hours PS)
- Non-opioid Rescue Medication - Ibuprofen(24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS)
- Participant Satisfaction With Study Medication - Day 14 PS(Day 14 PS)
- Participant Satisfaction With Study Medication - Day 28 PS(Day 28 PS)
- Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication(Discharge (day 3 up to day 7 PS), Day 28 PS)
- Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication(Discharge (day 3 up to day 7 PS), Day 28 PS)
- Integrated Analgesic Score(0-24, 24-48, 48-72 hours PS)
- Non-opioid Rescue Medication - Paracetamol(24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,)
- Percent Change From Baseline in Peak Expiratory Flow(Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible))
- Timed Up-and-Go (TUG)(Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS))
- Sleep Interference(Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS)
- Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores(Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS)
- Participant Satisfaction With Study Medication - Surgery Day(Day 1)
- Participant Satisfaction With Study Medication - Day 1 PS(Day 1 PS)
- Participant Satisfaction With Study Medication - Day 4 PS(Day 4 PS)
- Participant Satisfaction With Study Medication - Day 7 PS(Day 7 PS)
- Quality of Life Using EuroQol (EQ-5D) Health State Profile(Discharge (day 3 up to day 7 PS) and day 28 PS)
- Time to Actual Discharge(Day 1 up to Day 7 PS)
- Incidence of Chronic Post-operative Pain(3 and 6 Months PS)
- Total Clinically Meaningful Event (CME) Score(Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS)
研究者
研究点 (1)
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