Laryngeal DiseasesPhase 2/3NCT02552225
Treatment of Chronic Laryngitis With Amitriptyline
A Phase 2/3 study testing Amitriptyline in people with Laryngeal Diseases, run by Boston Medical Center at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Diseases
- What is being tested?
- Amitriptyline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 15 Jan 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be age 18 or older and able to consent for themselves
- Must have had structural pathology such as tumor previously ruled out using flexible laryngoscopy
- Must be able to speak and read the English language
- Must have failed a 2 month or longer trial of a proton pump inhibitor for the treatment of gastro-esophageal 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
- Potential subject and their physician have agreed that amitriptyline will be part of their regular care plan
Who cannot join
- Active untreated environmental allergies
- Smoking within past 5 years
- Current upper respiratory infections
- Use of narcotics (e.g. oxycodone, methadone) within the past week
- Hypersensitivity to amitriptyline
- History of amitriptyline use or of other tricyclic antidepressant - including pregabalin, gabapentin, baclofen, or other gamma-aminobutyric acid (GABA)analogues or inhibitors - for any medical condition (not limited to chronic laryngitis) within the past 12 months.
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- Use of any other monoamine oxidase inhibitors (MAOIs) other than amitriptyline within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate)
- History of urinary retention
- History of an acute episode of a major depressive disorder within the past 12 months
- 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)
- Currently participating in another clinical trial that could interfere with the efficacy of, or participation in, this study.
- Current untreated diagnosis of gastroesophageal reflux (GERD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline
This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Read the detailed description
Chronic laryngitis commonly manifests through symptoms including cough, hoarseness, throat clearing, foreign body sensation, throat pain, sensation of excessive phlegm, and difficulty swallowing. A significant minority also present with GERD, rhinosinusitis-induced post-nasal drainage, direct allergic effect, and smoking issues.
Amitriptyline is commonly used for mental/mood problems, but is also prescribed to treat chronic laryngitis because some investigators suggest a neuropathic etiology for idiopathic chronic laryngitis. No trials have compared any treatment for chronic laryngitis to placebo and it is unknown if currently used therapies for chronic laryngitis are effective.
At the baseline visit, subjects will be assigned at random to amitriptyline or placebo, which they will take for 4 weeks each. Subjects will be seen in the clinic at baseline and after 10 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.
- Conditions
- Laryngeal Diseases
- Being tested
- Amitriptyline, Placebo
- Keywords
- laryngeal sensory neuropathy, chronic laryngeal neuropathy
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Also called Elavil
Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
PlaceboOther
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
| Study group | Role | What they receive |
|---|---|---|
| amitriptyline | Experimental | Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Receives: Drug: Amitriptyline |
| placebo | Placebo comparator | Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on Reflux Symptom Index (RSI)
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.
Measured: baseline, 8 weeks
Secondary outcomes (6)
Change in the Score on the Voice Handicap Index-10 (VHI-10)
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.
Measured: baseline, 8 weeks
Change in the Score on the Cough Severity Index (CSI)
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.
Measured: baseline, 8 weeks
Change in Throat Pain or Burning
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.
Measured: baseline, 8 weeks
Change in Pain When Swallowing
Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain.
Measured: baseline, 8 weeks
Subjective Improvement of Laryngitis Symptoms
Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement.
Measured: 8 weeks
Number of Participants Who Dropped Out of the Study Due to Side Effects
The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startApr 2016
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Why it stopped: Funding was not obtained so the study could not be continued after the Covid pause.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laryngeal DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Pieter Noordzij, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552225
- Sponsor's protocol ID
- H 34438
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2015
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline
- ClinicalTrials.gov ID
- NCT02552225
- Acronym / sponsor ID
- H 34438
- Conditions
- Laryngeal Diseases
- Keywords
- laryngeal sensory neuropathy, chronic laryngeal neuropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was not obtained so the study could not be continued after the Covid pause.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Detailed description
Chronic laryngitis commonly manifests through symptoms including cough, hoarseness, throat clearing, foreign body sensation, throat pain, sensation of excessive phlegm, and difficulty swallowing. A significant minority also present with GERD, rhinosinusitis-induced post-nasal drainage, direct allergic effect, and smoking issues.
Amitriptyline is commonly used for mental/mood problems, but is also prescribed to treat chronic laryngitis because some investigators suggest a neuropathic etiology for idiopathic chronic laryngitis. No trials have compared any treatment for chronic laryngitis to placebo and it is unknown if currently used therapies for chronic laryngitis are effective.
At the baseline visit, subjects will be assigned at random to amitriptyline or placebo, which they will take for 4 weeks each. Subjects will be seen in the clinic at baseline and after 10 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amitriptyline | Experimental | Drug: AmitriptylineSubjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) |
| placebo | Placebo comparator | Other: PlaceboSubjects in this arm will receive pills composed only of Avicel (cellulose filler) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be age 18 or older and able to consent for themselves
- Must have had structural pathology such as tumor previously ruled out using flexible laryngoscopy
- Must be able to speak and read the English language
- Must have failed a 2 month or longer trial of a proton pump inhibitor for the treatment of gastro-esophageal 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
Key exclusion criteria (12 listed)
- Active untreated environmental allergies
- Smoking within past 5 years
- Current upper respiratory infections
- Use of narcotics (e.g. oxycodone, methadone) within the past week
- Hypersensitivity to amitriptyline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmitriptylineAlso: ElavilSubjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) | Drug | amitriptyline |
| PlaceboSubjects in this arm will receive pills composed only of Avicel (cellulose filler) | Other | placebo |
Primary outcome
Change in Score on Reflux Symptom Index (RSI)
Time frame: baseline, 8 weeks
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.
6 secondary outcomes
Change in the Score on the Voice Handicap Index-10 (VHI-10)
Time frame: baseline, 8 weeks
Change in the Score on the Cough Severity Index (CSI)
Time frame: baseline, 8 weeks
Change in Throat Pain or Burning
Time frame: baseline, 8 weeks
Change in Pain When Swallowing
Time frame: baseline, 8 weeks
Subjective Improvement of Laryngitis Symptoms
Time frame: 8 weeks
Number of Participants Who Dropped Out of the Study Due to Side Effects
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Pieter Noordzij, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amitriptyline in people with Laryngeal Diseases, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Score on Reflux Symptom Index (RSI) (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.