Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
研究概览
简要总结
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
详细描述
Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI between 5 and 20 events/h
- •PGI-S equal to or higher than 1, or one or more of the following symptoms:
- •Snoring or nightime gasping/choking
- •Daytime sleepiness, fatigue or decreased concentration
- •Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
- •Irritability, decreased mood or libido
排除标准
- •History of narcolepsy.
- •Clinically significant craniofacial malformation.
- •Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
- •CPAP should not be used for at least 2 weeks prior to the study
- •History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
研究组 & 干预措施
Sequence CAB
Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
干预措施: AD109 dose2- B (Drug)
Sequence ABC
AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
干预措施: AD109 dose1- A (Drug)
Sequence ABC
AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
干预措施: AD109 dose2- B (Drug)
Sequence ABC
AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
干预措施: Placebo- C (Drug)
Sequence ACB
AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
干预措施: AD109 dose1- A (Drug)
Sequence ACB
AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
干预措施: AD109 dose2- B (Drug)
Sequence ACB
AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
干预措施: Placebo- C (Drug)
Sequence BAC
AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
干预措施: AD109 dose1- A (Drug)
Sequence BAC
AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
干预措施: AD109 dose2- B (Drug)
Sequence BAC
AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
干预措施: Placebo- C (Drug)
Sequence BCA
AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
干预措施: AD109 dose1- A (Drug)
Sequence BCA
AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
干预措施: AD109 dose2- B (Drug)
Sequence BCA
AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
干预措施: Placebo- C (Drug)
Sequence CAB
Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
干预措施: AD109 dose1- A (Drug)
Sequence CAB
Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
干预措施: Placebo- C (Drug)
Sequence CBA
Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
干预措施: AD109 dose1- A (Drug)
Sequence CBA
Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
干预措施: AD109 dose2- B (Drug)
Sequence CBA
Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
干预措施: Placebo- C (Drug)
结局指标
主要结局
Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
时间窗: 1 night (8 hours)
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/h\]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
时间窗: 1 night (8 hours)
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
次要结局
未报告次要终点