A Prospective, Double-blind, Randomized, Placebo and Active Controlled, Multi-center, Parallel Group Study Comparing Remimazolam to Placebo, With an Additional Open-label Arm For Midazolam, in Patients Undergoing a Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 12
- 主要终点
- Success Rates of the Procedure
研究概览
简要总结
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example).
- •American Society of Anesthesiologists Score 1 through 3
- •Body mass index ≤40 kg/m
- •For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed).
- •Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure.
- •Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy.
排除标准
- •Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
- •Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity).
- •Chronic use of opioids for any indication.
- •Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline.
- •Lactating female patients.
- •Patients with positive drugs of abuse screen or a positive serum ethanol at baseline.
- •Patient with a history of drug or ethanol abuse within the past 2 years.
- •Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period.
- •Participation in any previous clinical trial with remimazolam.
- •Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
研究组 & 干预措施
Remimazolam
Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
干预措施: Remimazolam (Drug)
Placebo
Inactive control arm
Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
干预措施: Placebo (Drug)
Midazolam
Midazolam iv 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance.
*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill
Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
干预措施: Midazolam (Drug)
结局指标
主要结局
Success Rates of the Procedure
时间窗: From administration of the first dose of the study drug to the end of colonoscopy
Success of the Procedure is measured by completion of colonoscopy, no requirement for an alternative sedative and no requirement for more than 5 top-ups of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the midazolam arm.
次要结局
- Time to Ready for Discharge(From the end of the colonoscopy until discharge (expected to be the same day). After the last dose of study drug or rescue sedative, until discharge (expected to be the same day).)
- Time to Start of Procedure(From first dose of study drug until insertion of the colonoscope)
- Time to Fully Alert(From the end of colonoscopy (colonoscope out) until the patient has recovered to fully alert and from the last injection of the study drug or rescue sedative medication until the patient has recovered to fully alert)