A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects With Chronic Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 14
- 主要终点
- Number of Subjects With Serious Adverse Events
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Chronic Cough
详细描述
A Phase 2, multicenter, randomized, double-blind, placebo controlled, two-period crossover trial to evaluate the safety, tolerability, and efficacy of ADX-629 (300 mg) administered orally, twice-a-day to eligible participants with refractory or unexplained chronic cough. Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 to ≤80 years of age
- •History of refractory or unexplained chronic cough
- •Historical Chest radiograph or CT scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough
- •Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable
- •Agree to discontinue antitussive medications for the trial duration
排除标准
- •Current smoker (including cannabis products) or previous smoker having recently given up smoking or has a history of smoking of >20 pack-years
- •History of significant cardiovascular disease or any clinically significant abnormalities in rhythm or conduction
- •History or presence of significant hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •History of any malignancy within 5 years of screening except for basal cell or squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- •Recent history of drug or alcohol abuse or a positive urine drug test at screening
- •Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1 and HIV-2
- •Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI within 3 months of Screening.
研究组 & 干预措施
ADX-629
Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days.
干预措施: ADX-629 (Drug)
Placebo
Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Serious Adverse Events
时间窗: The safety assessment period was Day 1 - Day 14 for each treatment period.
Safety was assessed through serious adverse event collection.
次要结局
- Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor(The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.)
- Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor(The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.)
- Change From Baseline in Awake Cough Frequency Per Hour for Period 1(The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.)
- Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1(The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.)