Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough (NCT05110144) | Clinical Trial Compass
RecruitingPhase 2
Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough
United States50 participantsStarted 2021-11-01
Plain-language summary
This research study is evaluating the effectiveness of escalating doses of Amitriptyline and Duloxetine in reducing cough frequency in patients with refractory chronic cough (RCC)
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria
* Chest radiograph or computed tomography (CT) of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough in the opinion of the Principal Investigator
* Have a diagnosis of refractory chronic cough or unexplained cough for at least one year according to the American College of Chest Physicians guidelines
* Have a score of ≥ 40mm on the Cough Severity VAS at Screening.
* Women of child-bearing potential must agree to use 2 forms of acceptable birth control and make no donation of eggs from Screening through the end of the 8-week study period. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When concordant with the preferred lifestyle of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
* Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug at the end of 8 weeks.
* Have provided written informed consent.
* Are willing and able …
What they're measuring
1
Change in awake objective cough frequency (at 4 & 8 weeks)