A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough (NCT05392192) | Clinical Trial Compass
CompletedPhase 2
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
United States51 participantsStarted 2022-04-07
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of Subjects With Serious Adverse Events
Timeframe: The safety assessment period was Day 1 - Day 14 for each treatment period.