Trial of the Treatment of Chronic Laryngitis With Amitryptiline

NCT02434523 | Terminated Phase 2 Results DMC

• 1 other identifier: H-29925
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laryngeal Diseases; Chronic Laryngeal Neuropathy

Keywords

laryngeal sensory neuropathy

Outcome Measures

Primary Outcomes (1)

• Reflux Symptom Index

  Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes

  8 weeks

Secondary Outcomes (3)

• Voice Handicap Index

  8 weeks

• Side Effects

  8 weeks

• Lost to Follow up

  8 weeks

Study Arms (2)

amitriptyline

EXPERIMENTAL

Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)

Drug: Amitriptyline

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

Other: Placebo

Interventions

Amitriptyline DRUG

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

Also known as: treatment arm

amitriptyline

Placebo OTHER

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

Also known as: placebo arm

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Medical Center: lead
• American Laryngological Association: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Jacob Pieter Noordzij
• Organization: Boston Medical Center

Pieter.Noordzij@bmc.org

617-638-8124

Study Officials

• J. Pieter Noordzij, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Attending Physician

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 5, 2015
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 30, 2016
• Results First Posted: November 30, 2016

Record last verified: 2016-10

Locations

US (1)