- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434523
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
October 7, 2016 updated by: J Pieter Noordzij, Boston Medical Center
Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: amitriptyline
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)
|
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 Names:
|
Placebo Comparator: Placebo
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks
|
Side Effects
Time Frame: 8 weeks
|
number of patients with side effects, type of side effects
|
8 weeks
|
Lost to Follow up
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: J. Pieter Noordzij, MD, Boston Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
April 22, 2015
First Submitted That Met QC Criteria
May 4, 2015
First Posted (Estimate)
May 5, 2015
Study Record Updates
Last Update Posted (Estimate)
November 30, 2016
Last Update Submitted That Met QC Criteria
October 7, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Laryngeal Diseases
- Laryngitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Amitriptyline
Other Study ID Numbers
- H-29925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
No plan to share individual data.
Data in aggregate to be presented in national meeting and journal in otolaryngology
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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