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NCT05110144 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough
A Phase 2 study of Refractory Chronic Cough, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05110144: Recruiting Phase 2 study of Refractory Chronic Cough, sponsored by Mayo Clinic.
NCT05110144 is a Phase 2 study of Refractory Chronic Cough that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 50 participants, below the 381-participant average among 5 other Refractory Chronic Cough trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05110144, a Phase 2 study of Refractory Chronic Cough, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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)
Primary Outcome
The primary objective is to evaluate awake cough frequency at 4 and 8 weeks using the Leicester Cough Monitor. The acoustic cough monitor recordings will be analyzed using the Leicester Cough Monitor program V2.3-MB. This will also be performed at months 4, 6, 9 \& 12 for subjects who choose to continue with the optional unblinded continuation of the study after the initial 8 weeks.
Conditions Studied
Interventions
- DRUG Duloxetine 30 MG
- DRUG Amitriptyline 25 MG
- DRUG Amitriptyline 50 MG
- DRUG Duloxetine 60 MG
- DRUG Placebo 30 MG
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05110144 shows while recruiting
NCT05110144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 381-participant average among 5 other Refractory Chronic Cough trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Refractory Chronic Cough appearing as the primary indexed condition, and to 5 interventions - of which Duloxetine 30 MG is the first listed.
NCT05110144 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05110144 about?
NCT05110144 is a clinical study titled "Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough". 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)
What is the current status of trial NCT05110144?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-11-01. Estimated completion is 2026-12.
What conditions does trial NCT05110144 study?
This clinical trial studies the following conditions: Refractory Chronic Cough.
What interventions are being tested in trial NCT05110144?
The interventions under investigation include: Duloxetine 30 MG (DRUG), Amitriptyline 25 MG (DRUG), Amitriptyline 50 MG (DRUG), Duloxetine 60 MG (DRUG), Placebo 30 MG (DRUG).
Who is sponsoring clinical trial NCT05110144?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05110144 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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