Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Laryngeal Diseases Clinical Trial

Official title:

Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02434523
• Other study ID #: H-29925
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 22, 2015
• Last updated: September 9, 2015
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2013
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: Boston University Medical Center Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Laryngeal Neuropathy
• Laryngeal Diseases
• Laryngitis

Intervention

Drug:
• Amitriptyline

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	American Laryngological Association

Country where clinical trial is conducted

United States, 

Outcome

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