Trial of the Treatment of Chronic Laryngitis With Amitryptiline

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: American Laryngological Association
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

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).