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Trial record 22 of 135 for:    AMITRIPTYLINE

Trial of the Treatment of Chronic Laryngitis With Amitryptiline

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Laryngeal Diseases
Chronic Laryngeal Neuropathy
Interventions Drug: Amitriptyline
Other: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description 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 Subjects in this arm will receive pills composed only of 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
Period Title: Overall Study
Started 15 15
Completed 10 9
Not Completed 5 6
Arm/Group Title Amitriptyline Placebo Total
Hide Arm/Group Description 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 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 Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  93.3%
12
  80.0%
26
  86.7%
>=65 years
1
   6.7%
3
  20.0%
4
  13.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
45  (15) 50  (14) 48  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
5
  33.3%
10
  66.7%
15
  50.0%
Male
10
  66.7%
5
  33.3%
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
Reflux Symptom Index (RSI) Score  
Mean (Standard Deviation)
Unit of measure:  Severity on Likert-type scale
Number Analyzed 15 participants 15 participants 30 participants
19  (10) 24  (10) 22  (9)
1.Primary Outcome
Title Reflux Symptom Index
Hide Description Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed treatment and post-treatment questionnaire
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.7  (7.1) 0.3  (12.0)
2.Secondary Outcome
Title Voice Handicap Index
Hide Description Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.7  (6.1) 0  (4.3)
3.Secondary Outcome
Title Side Effects
Hide Description number of patients with side effects, type of side effects
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

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

Amitriptyline

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

Placebo: Placebo pill

Overall Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: participants
Dizziness 4 2
Fatigue 3 1
Dry mouth 1 2
4.Secondary Outcome
Title Lost to Follow up
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
number of subjects in each arm who were lost to follow up
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
5 6
Time Frame 1 year
Adverse Event Reporting Description

Adverse event definitions used from http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf, Sections 1.2, 1.50, 1.60; http://www.fda.gov/downloads/Drugs/.../Guidances/UCM227351.pdf

Full definitions not listed due to character limit of 500

 
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description 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 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
All-Cause Mortality
Amitriptyline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amitriptyline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amitriptyline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/15 (40.00%)      2/15 (13.33%)    
Nervous system disorders     
Adverse Effect * [1]  6/15 (40.00%)  15 2/15 (13.33%)  15
*
Indicates events were collected by non-systematic assessment
[1]
Not an adverse event. Non-serious adverse effects include dizziness, fatigue, and dry mouth.
Early termination leading to small numbers of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jacob Pieter Noordzij
Organization: Boston Medical Center
Phone: 617-638-8124
EMail: Pieter.Noordzij@bmc.org
Layout table for additonal information
Responsible Party: J Pieter Noordzij, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02434523     History of Changes
Other Study ID Numbers: H-29925
First Submitted: April 22, 2015
First Posted: May 5, 2015
Results First Submitted: March 29, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016