Trial Outcomes & Findings for Trial of the Treatment of Chronic Laryngitis With Amitryptiline (NCT NCT02434523)

NCT ID: NCT02434523

Last Updated: 2016-11-30

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2016-11-30

Participant Flow

Participant milestones

Measure	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	Placebo 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
Overall Study STARTED	15	15
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Baseline characteristics by cohort

Measure	Amitriptyline n=15 Participants 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	Placebo n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 15 • n=5 Participants	50 years STANDARD_DEVIATION 14 • n=7 Participants	48 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Reflux Symptom Index (RSI) Score	19 severity on Likert-type scale STANDARD_DEVIATION 10 • n=5 Participants	24 severity on Likert-type scale STANDARD_DEVIATION 10 • n=7 Participants	22 severity on Likert-type scale STANDARD_DEVIATION 9 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Patients who completed treatment and post-treatment questionnaire

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

Outcome measures

Measure	Amitriptyline n=9 Participants 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	Placebo n=9 Participants 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
Reflux Symptom Index	-2.7 units on a scale Standard Deviation 7.1	0.3 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: 8 weeks

Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes

Outcome measures

Measure	Amitriptyline n=9 Participants 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	Placebo n=9 Participants 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
Voice Handicap Index	3.7 units on a scale Standard Deviation 6.1	0 units on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: 8 weeks

number of patients with side effects, type of side effects

Outcome measures

Measure	Amitriptyline n=9 Participants 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	Placebo n=9 Participants 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
Side Effects Dizziness	4 participants	2 participants
Side Effects Fatigue	3 participants	1 participants
Side Effects Dry mouth	1 participants	2 participants

SECONDARY outcome

Timeframe: 8 weeks

Population: number of subjects in each arm who were lost to follow up

Outcome measures

Measure	Amitriptyline n=15 Participants 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	Placebo n=15 Participants 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
Lost to Follow up	5 participants	6 participants

Adverse Events

Amitriptyline

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Amitriptyline n=15 participants at risk 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	Placebo n=15 participants at risk 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
Nervous system disorders Adverse Effect	40.0% 6/15 • Number of events 15 • 1 year 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	13.3% 2/15 • Number of events 15 • 1 year 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

Additional Information

Dr. Jacob Pieter Noordzij

Boston Medical Center

Phone: 617-638-8124

Email: Pieter.Noordzij@bmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place