RecruitingPhase 2NCT05110144

Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Efficacy of Two Doses of Duloxetine & Amitriptyline in Subjects With Refractory Chronic Cough


Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two doses of two medications — duloxetine and amitriptyline — both used for nerve-related conditions, to find the most effective treatment for people with a persistent cough that hasn't responded to standard treatments (called refractory or unexplained chronic cough). **You may be eligible if...** - You have had a persistent cough for at least 1 year that has not responded to standard treatment - Your cough severity is rated at least 40mm on a standard visual scale - A chest X-ray or CT scan within the last year shows no major lung abnormality explaining your cough - You are willing to use adequate contraception if you could become pregnant **You may NOT be eligible if...** - Your cough is explained by a significant lung condition - You have had the cough for less than 1 year - Your cough severity is below the minimum threshold - You are pregnant, breastfeeding, or unable to use birth control during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05110144


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