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
Overview
- Phase
- Phase 2
- Intervention
- ADX-629
- Conditions
- Chronic Cough
- Sponsor
- Aldeyra Therapeutics, Inc.
- Enrollment
- 51
- Locations
- 14
- Primary Endpoint
- Number of Subjects With Serious Adverse Events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
ADX-629
Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days.
Intervention: ADX-629
Placebo
Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Subjects With Serious Adverse Events
Time Frame: The safety assessment period was Day 1 - Day 14 for each treatment period.
Safety was assessed through serious adverse event collection.
Secondary Outcomes
- 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.)