A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 20
- 主要终点
- Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model
研究概览
简要总结
This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:
- to evaluate the effect of alvimopan on hospital length of stay
- to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities
- to evaluate the overall and cardiovascular safety of alvimopan
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
- •are either Male or Female at least 18 years of age
- •are scheduled for radical cystectomy
- •are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics
排除标准
- •are scheduled for a partial cystectomy
- •have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery
研究组 & 干预措施
Alvimopan
12 milligrams (mg)
Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment
干预措施: Alvimopan (Drug)
Placebo
300 mg polyethylene glycol in a capsule
Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model
时间窗: From day of surgery (Day 0) up to 10 days in hospital
Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement \[BM\]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
次要结局
- Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model(Day of surgery (Day 0) up to 10 days in hospital)
- Mean Time to Discharge Order Written (DOW) Using KM Estimates(Day of surgery (Day 0) up to 10 days in hospital)
- Postoperative Length of Stay (LOS)(Day of surgery (Day 0) to the day of hospital DOW)
- Percentage of Participants Considered Postoperative LOS Responders(Day of surgery (Day 0) up to 7 days after surgery)
- Percentage of Participants With Postoperative Morbidity (POM)(During hospitalization or within 7 days after discharge)
- Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points(Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7)
- Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points(Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7)
- Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events(Baseline to 30 days post discharge)