Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Overview
- Phase
- Phase 2
- Intervention
- Amitriptyline
- Conditions
- Laryngeal Diseases
- Sponsor
- Boston Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Reflux Symptom Index
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Detailed Description
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.
Investigators
J Pieter Noordzij
BMC Attending Physician
Boston Medical Center
Eligibility 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.
Arms & Interventions
amitriptyline
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)
Intervention: Amitriptyline
Placebo
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Intervention: Placebo
Outcomes
Primary Outcomes
Reflux Symptom Index
Time Frame: 8 weeks
Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
Secondary Outcomes
- Voice Handicap Index(8 weeks)
- Side Effects(8 weeks)
- Lost to Follow up(8 weeks)