Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Chronic Cough
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05392192
Start Date
April 7 2022
End Date
April 13 2023
Last Update
February 28 2025
Active Locations (14)
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1
Allergy Associates Medical Group, Inc.
San Diego, California, United States, 92108
2
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117
3
Cano Research - Hollywood
Hollywood, Florida, United States, 33024
4
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, United States, 33470