Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Laryngeal Diseases, Chronic Laryngeal Neuropathy
In brief
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Key facts
- Study ID
- NCT02434523
- Run by
- Boston Medical Center
- People needed
- 30
- Starts
- 2013-09-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-11-30
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 or older and able to consent for themselves.
- Structural pathology such as tumor previously ruled out using flexible laryngoscopy.
- Able to speak and read the English language.
- Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal reflux.
- Women under 55 years of age who may become pregnant must have a negative pregnancy test and agree to barrier or hormonal methods of contraception during the study.
You may not qualify if…
- Environmental allergies.
- Smoking within past 5 years.
- Using ginko bilboa (or unwilling to cease using it).
- Current upper respiratory infections.
- Use of narcotics (e.g. oxycodone, methadone).
- Any prior history of amitryptiline use.
- Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).
- History of urinary retention.
- Any history of major depressive disorder.
- Any prior history of allergy to a tricyclic antidepressant.
- Current diagnosis of gastroesophageal reflux (GERD).
- For women 18-55 years of age without history of menopause: currently nursing or pregnant, plans to become pregnant, or unwillingness to utilize contraception (barrier or hormonal methods).
Where it is running
- Boston Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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