A Double-blind, Randomized, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 153
- 试验地点
- 23
- 主要终点
- Number of Participants With Sedation Success
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
详细描述
This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age >/= 65 years, and/or weight < 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight >/= 55 kg and weight < 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
fospropofol disodium Subgroup 1 Lower Dose
干预措施: fospropofol disodium Subgroup 1 Lower Dose (Drug)
: fospropofol disodium Subgroup 1 Approved Dose
干预措施: fospropofol disodium Subgroup 1 Approved Dose (Drug)
fospropofol disodium Subgroup 2 Lower Dose
干预措施: fospropofol disodium Subgroup 2 Lower Dose (Drug)
fospropofol disodium Subgroup 2 Approved Dose
干预措施: fospropofol disodium Subgroup 2 Approved Dose (Drug)
fospropofol disodium Subgroup 3 Lower Dose
干预措施: fospropofol disodium Subgroup 3 Lower Dose (Drug)
fospropofol disodium Subgroup 3 Approved Dose
干预措施: fospropofol disodium Subgroup 3 Approved Dose (Drug)
结局指标
主要结局
Number of Participants With Sedation Success
时间窗: Day 1
Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.
次要结局
- Number of Participants With Treatment Success(Day 1)
- Number of Participants With Modified Sedation Success(Day 1)