Trial of the Treatment of Chronic Laryngitis With Amitryptiline
NCT ID: NCT02434523
Last Updated: 2016-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2013-09-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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amitriptyline
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)
Amitriptyline
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
Placebo
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Placebo
Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
Interventions
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Amitriptyline
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
Placebo
Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
64 Years
ALL
No
Sponsors
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American Laryngological Association
OTHER
Boston Medical Center
OTHER
Responsible Party
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J Pieter Noordzij
BMC Attending Physician
Principal Investigators
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J. Pieter Noordzij, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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H-29925
Identifier Type: -
Identifier Source: org_study_id