Laryngeal DiseasesPhase 2/3NCT02434523
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
A Phase 2/3 study testing Amitriptyline in people with Laryngeal Diseases and Chronic Laryngeal Neuropathy, run by Boston Medical Center at 1 site in United States.
Trial summary
The study 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 to 64 years
- Conditions the study is for
- Laryngeal Diseases, Chronic Laryngeal Neuropathy
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2015
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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).
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 Amitryptiline
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Read the 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.
- Conditions
- Laryngeal Diseases, Chronic Laryngeal Neuropathy
- Being tested
- Amitriptyline, Placebo
- Keywords
- laryngeal sensory 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 treatment arm
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
PlaceboOther
Also called placebo arm
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
| Study group | Role | What they receive |
|---|---|---|
| amitriptyline | Experimental | Subjects in this arm will receive pills composed of amitryptline 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.
Reflux Symptom Index
Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
Measured: 8 weeks
Secondary outcomes (3)
Voice Handicap Index
Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
Measured: 8 weeks
Side Effects
number of patients with side effects, type of side effects
Measured: 8 weeks
Lost to Follow up
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 posted5 May 2015 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: concern regarding study design
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Laryngological Association
- Responsible party
- Principal investigator, J Pieter Noordzij, Boston Medical Center
- Investigators
- J. Pieter Noordzij, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434523
- Sponsor's protocol ID
- H-29925
- Status last verified
- Oct 2016
- First submitted
- 22 Apr 2015
- Last updated
- 30 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. 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 Amitryptiline
- ClinicalTrials.gov ID
- NCT02434523
- Acronym / sponsor ID
- H-29925
- Conditions
- Laryngeal Diseases, Chronic Laryngeal Neuropathy
- Keywords
- laryngeal sensory neuropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: concern regarding study design
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- American Laryngological Association
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Posted 30 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amitriptyline | Experimental | Drug: AmitriptylineSubjects in this arm will receive pills composed of amitryptline 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 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
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: treatment armSubjects 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 | Drug | amitriptyline |
| PlaceboAlso: placebo armSubjects 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 | Placebo |
Primary outcome
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
3 secondary outcomes
Voice Handicap Index
Time frame: 8 weeks
Side Effects
Time frame: 8 weeks
Lost to Follow up
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 30 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology
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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 and Chronic Laryngeal Neuropathy, 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 5 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 30 Nov 2016. 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 30 Nov 2016). 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?
Reflux Symptom Index (time frame: 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 30 Nov 2016.