Trial of the Treatment of Chronic Laryngitis With Amitryptiline (NCT02434523) | Clinical Trial Compass
TerminatedPhase 2/3
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Stopped: concern regarding study design
United States30 participantsStarted 2013-09
Plain-language summary
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).