A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Efficacy of Two Doses of Duloxetine & Amitriptyline in Subjects With Refractory Chronic Cough
Mayo Clinic
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)
Description
This is a randomized, double-blind, placebo-controlled, parallel-arm, dose escalation study of Duloxetine \& Amitriptyline in subjects with refractory chronic cough. Subjects will be screened during a period of up to 2 week and will undergo screening/ baseline cough monitoring. A total of 50 subjects who meet entry criteria will be randomly assigned in a 1: 1: 1: 1: 1 ratio to one of five treatment arms using stratified randomization in blocks of 10. Each arm will have two successive 4-week treatment periods (Blinded Period 1 \& 2). After this, patients will be unblinded and receive routine cl…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 fro…
Interventions
- DrugDuloxetine 30 MG
30mg orally for 4 weeks
- DrugDuloxetine 60 MG
60mg orally for 4 weeks
- DrugAmitriptyline 25 MG
25 mg orally for 4 weeks
- DrugAmitriptyline 50 MG
50 mg orally for 4 weeks
- DrugPlacebo 30 MG
30mg tablet with no active study ingredient for 4 weeks
- DrugPlacebo 60 MG
60mg tablet with no active study ingredient for 4 weeks
Location
- Mayo Clinic in RochesterRochester, Minnesota