Laryngeal Diseases Clinical Trial
Official title:
Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen in the clinic at baseline and at 8 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.
Status | Terminated |
Enrollment | 29 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | American Laryngological Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | voice handicap index | 8 weeks | No | |
Primary | reflux symptom index | 8 weeks | No | |
Secondary | side effects (number of patients with side effects, type of side effects) | number of patients with side effects, type of side effects | 8 weeks | No |
Secondary | rate of discontinuation | 8 weeks | No |
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