Trial of the Treatment of Chronic Laryngitis With Amitryptiline

• ClinicalTrials.gov Identifier: NCT02434523
• Recruitment Status: Terminated
• First Posted: May 5, 2015
• Results First Posted: November 30, 2016
• Last Update Posted: November 30, 2016
• Sponsor: Boston Medical Center
• Collaborator: American Laryngological Association
• Information provided by (Responsible Party): J Pieter Noordzij, Boston Medical Center

Tracking Information

• First Submitted Date: April 22, 2015
• First Posted Date: May 5, 2015
• Results First Submitted Date: March 29, 2016
• Results First Posted Date: November 30, 2016
• Last Update Posted Date: November 30, 2016
• Study Start Date: September 2013
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 7, 2016)

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

Original Primary Outcome Measures (submitted: May 4, 2015)

• voice handicap index [ Time Frame: 8 weeks ]
• Reflux Symptom Index [ Time Frame: 8 weeks ]

• Change History: Complete list of historical versions of study NCT02434523 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: October 7, 2016)

• Voice Handicap Index [ Time Frame: 8 weeks ]
  Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
• Side Effects [ Time Frame: 8 weeks ]
  number of patients with side effects, type of side effects
• Lost to Follow up [ Time Frame: 8 weeks ]

Original Secondary Outcome Measures (submitted: May 4, 2015)

• side effects (number of patients with side effects, type of side effects) [ Time Frame: 8 weeks ]
  number of patients with side effects, type of side effects
• rate of discontinuation [ Time Frame: 8 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial of the Treatment of Chronic Laryngitis With Amitryptiline
• Official Title: Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
• 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Laryngeal Diseases
• Chronic Laryngeal Neuropathy

Intervention

• Drug: 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
  Other Name: treatment arm
• Other: 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 Name: placebo arm

Study Arms

• Experimental: amitriptyline
  Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)
  Intervention: Drug: Amitriptyline
• Placebo Comparator: Placebo
  Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 7, 2016): 30
• Original Estimated Enrollment (submitted: May 4, 2015): 80
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

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.
• 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02434523
• Other Study ID Numbers: H-29925
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology

• Responsible Party: J Pieter Noordzij, Boston Medical Center
• Study Sponsor: Boston Medical Center
• Collaborators: American Laryngological Association

Investigators

• Principal Investigator: J. Pieter Noordzij, MD; Boston Medical Center

• PRS Account: Boston Medical Center
• Verification Date: October 2016