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Trial record 22 of 135 for:    AMITRIPTYLINE

Trial of the Treatment of Chronic Laryngitis With Amitryptiline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434523
Recruitment Status : Terminated (concern regarding study design)
First Posted : May 5, 2015
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Collaborator:
American Laryngological Association
Information provided by (Responsible Party):
J Pieter Noordzij, Boston Medical Center

Tracking Information
First Submitted Date  ICMJE April 22, 2015
First Posted Date  ICMJE May 5, 2015
Results First Submitted Date  ICMJE March 29, 2016
Results First Posted Date  ICMJE November 30, 2016
Last Update Posted Date November 30, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Laryngeal Diseases
  • Chronic Laryngeal Neuropathy
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 7, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2015)
80
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02434523
Other Study ID Numbers  ICMJE H-29925
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Boston Medical Center
Collaborators  ICMJE American Laryngological Association
Investigators  ICMJE
Principal Investigator: J. Pieter Noordzij, MD Boston Medical Center
PRS Account Boston Medical Center
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP