Trial Outcomes & Findings for Treatment of Chronic Laryngitis With Amitriptyline (NCT NCT02552225)

Last Updated: 2021-10-29

Results Overview

The Reflux Symptom Index (RSI) is a validated questionnaire consisting of 9 statements to be ranked on a scale of 0-5 (0=no problem, 5=severe problem). RSI scores can range from 0 to 45, with higher scores correlated with more reflux symptoms.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

6 participants

Primary outcome timeframe

baseline, 8 weeks

Results posted on

2021-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Amitriptyline Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Overall Study STARTED	3	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Amitriptyline Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Treatment of Chronic Laryngitis With Amitriptyline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amitriptyline n=3 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)	Total n=6 Participants Total of all reporting groups
Age, Continuous	52.3 years STANDARD_DEVIATION 19.9 • n=5 Participants	55.0 years STANDARD_DEVIATION 6.6 • n=7 Participants	53.7 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Reflux Symptom Index (RSI)	21.33 score on a scale STANDARD_DEVIATION 11.50 • n=5 Participants	25.67 score on a scale STANDARD_DEVIATION 6.51 • n=7 Participants	23.50 score on a scale STANDARD_DEVIATION 8.69 • n=5 Participants
Voice Handicap Index-10 (VHI-10)	1.67 units on a scale STANDARD_DEVIATION 2.89 • n=5 Participants	9.67 units on a scale STANDARD_DEVIATION 9.5 • n=7 Participants	5.67 units on a scale STANDARD_DEVIATION 7.66 • n=5 Participants
Cough Severity Index (CSI)	4.00 units on a scale STANDARD_DEVIATION 5.66 • n=5 Participants	21.33 units on a scale STANDARD_DEVIATION 12.42 • n=7 Participants	14.40 units on a scale STANDARD_DEVIATION 13.24 • n=5 Participants
Throat pain/burning	0.0 units on a scale STANDARD_DEVIATION 0.0 • n=5 Participants	3.33 units on a scale STANDARD_DEVIATION 1.53 • n=7 Participants	1.67 units on a scale STANDARD_DEVIATION 2.07 • n=5 Participants
Pain when swallowing	0.67 units on a scale STANDARD_DEVIATION 1.15 • n=5 Participants	0.67 units on a scale STANDARD_DEVIATION 0.58 • n=7 Participants	0.67 units on a scale STANDARD_DEVIATION 0.82 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 8 weeks

Population: There was no 8 week RSI score for the participant who withdrew from the amitriptyline arm so the change in score could not be calculated.

Outcome measures

Outcome measures
Measure	Amitriptyline n=2 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Change in Score on Reflux Symptom Index (RSI)	-2 score on a scale Standard Deviation 1.41	-1.67 score on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: baseline, 8 weeks

Population: There was no 8 week VHI-10 score for the participant who withdrew from the amitriptyline arm so the change in score could not be calculated.

The Voice Handicap Index-10 (VHI-10) is a 10-question scale rated from 0-4 that addresses effects on quality of life from voice disorders (0=never, 1=almost never, 2=sometimes, 3=almost always, 4=always). VHI-10 scores can range from 0 to 40, with lower scores correlated with a higher quality of life related to voice disorders.

Outcome measures

Outcome measures
Measure	Amitriptyline n=2 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Change in the Score on the Voice Handicap Index-10 (VHI-10)	8.0 units on a scale Standard Deviation 11.31	2.67 units on a scale Standard Deviation 4.04

SECONDARY outcome

Timeframe: baseline, 8 weeks

Population: There was no 8 week CSI score for the participant who withdrew from the amitriptyline arm so the change in score could not be calculated.

The Cough Severity Index is a validated 10 item questionnaire to quantify a patient's symptoms associated with upper airway chronic cough. The 4 point Likert scale for each of the 10 items is 0 to 4 where 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Almost always, 4 = Always. Scores can range from 0 to 40 and higher scores reflect more coughing.

Outcome measures

Outcome measures
Measure	Amitriptyline n=2 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Change in the Score on the Cough Severity Index (CSI)	10 units on a scale Standard Deviation 14.14	3.67 units on a scale Standard Deviation 5.51

SECONDARY outcome

Timeframe: baseline, 8 weeks

Population: There was no 8 week assessment of throat pain/burning for the participant who withdrew from the amitriptyline arm, so the change in score could not be calculated.

Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning.

Outcome measures

Outcome measures
Measure	Amitriptyline n=2 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Change in Throat Pain or Burning	2.0 units on a scale Standard Deviation 2.83	-1.33 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: baseline, 8 weeks

Population: There was no 8 week assessment of pain while swallowing for the participant who withdrew from the amitriptyline arm, so the change in score could not be calculated.

Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain.

Outcome measures

Outcome measures
Measure	Amitriptyline n=2 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Change in Pain When Swallowing	1.0 units on a scale Standard Deviation 4.24	0.33 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: 8 weeks

Population: There was no 8 week assessment of subjective assessment of laryngitis symptoms for the participant who withdrew from the amitriptyline arm, so it could ot be reported.

Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement.

Outcome measures

Outcome measures
Measure	Amitriptyline n=2 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Subjective Improvement of Laryngitis Symptoms	8.0 units on a scale Standard Deviation 0	2.0 units on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: 8 weeks

The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs.

Outcome measures

Outcome measures
Measure	Amitriptyline n=3 Participants Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 Participants Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Number of Participants Who Dropped Out of the Study Due to Side Effects	1 Participants	0 Participants

Adverse Events

Amitriptyline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Amitriptyline n=3 participants at risk Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)	Placebo n=3 participants at risk Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • 8 weeks	0.00% 0/3 • 8 weeks
General disorders Dizziness	66.7% 2/3 • Number of events 2 • 8 weeks	33.3% 1/3 • Number of events 1 • 8 weeks
Cardiac disorders Tachycardia	33.3% 1/3 • Number of events 1 • 8 weeks	0.00% 0/3 • 8 weeks
General disorders Chest pain	33.3% 1/3 • Number of events 1 • 8 weeks	0.00% 0/3 • 8 weeks
General disorders Arm weakness	33.3% 1/3 • Number of events 1 • 8 weeks	0.00% 0/3 • 8 weeks
General disorders Facial weakness	33.3% 1/3 • Number of events 1 • 8 weeks	0.00% 0/3 • 8 weeks
Gastrointestinal disorders Indigestion	33.3% 1/3 • Number of events 1 • 8 weeks	0.00% 0/3 • 8 weeks
General disorders Insomnia	33.3% 1/3 • Number of events 1 • 8 weeks	0.00% 0/3 • 8 weeks
General disorders Headache	0.00% 0/3 • 8 weeks	33.3% 1/3 • Number of events 1 • 8 weeks
Gastrointestinal disorders Nausea	0.00% 0/3 • 8 weeks	33.3% 1/3 • Number of events 1 • 8 weeks
General disorders Lack of energy	0.00% 0/3 • 8 weeks	33.3% 1/3 • Number of events 1 • 8 weeks
General disorders Sleepy	0.00% 0/3 • 8 weeks	33.3% 1/3 • Number of events 1 • 8 weeks
General disorders Dry mouth	0.00% 0/3 • 8 weeks	33.3% 1/3 • Number of events 1 • 8 weeks

Additional Information

Pieter Noordzij, MD

Boson Medical Center

Phone: (617) 414-1756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place