{"protocolSection":{"identificationModule":{"nctId":"NCT02434523","orgStudyIdInfo":{"id":"H-29925"},"organization":{"fullName":"Boston Medical Center","class":"OTHER"},"briefTitle":"Trial of the Treatment of Chronic Laryngitis With Amitryptiline","officialTitle":"Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline"},"statusModule":{"statusVerifiedDate":"2016-10","overallStatus":"TERMINATED","whyStopped":"concern regarding study design","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-09"},"primaryCompletionDateStruct":{"date":"2015-01","type":"ACTUAL"},"completionDateStruct":{"date":"2015-01","type":"ACTUAL"},"studyFirstSubmitDate":"2015-04-22","studyFirstSubmitQcDate":"2015-05-04","studyFirstPostDateStruct":{"date":"2015-05-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-03-29","resultsFirstSubmitQcDate":"2016-10-07","resultsFirstPostDateStruct":{"date":"2016-11-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-10-07","lastUpdatePostDateStruct":{"date":"2016-11-30","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"J Pieter Noordzij","investigatorTitle":"BMC Attending Physician","investigatorAffiliation":"Boston Medical Center"},"leadSponsor":{"name":"Boston Medical Center","class":"OTHER"},"collaborators":[{"name":"American Laryngological Association","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.","detailedDescription":"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."},"conditionsModule":{"conditions":["Laryngeal Diseases","Chronic Laryngeal Neuropathy"],"keywords":["laryngeal sensory neuropathy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"amitriptyline","type":"EXPERIMENTAL","description":"Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)","interventionNames":["Drug: Amitriptyline"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Amitriptyline","description":"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","armGroupLabels":["amitriptyline"],"otherNames":["treatment arm"]},{"type":"OTHER","name":"Placebo","description":"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","armGroupLabels":["Placebo"],"otherNames":["placebo arm"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Reflux Symptom Index","description":"Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"Voice Handicap Index","description":"Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes","timeFrame":"8 weeks"},{"measure":"Side Effects","description":"number of patients with side effects, type of side effects","timeFrame":"8 weeks"},{"measure":"Lost to Follow up","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age 18 or older and able to consent for themselves.\n* Structural pathology such as tumor previously ruled out using flexible laryngoscopy.\n* Able to speak and read the English language.\n* Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal reflux.\n* 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.\n\nExclusion Criteria:\n\n* Environmental allergies.\n* Smoking within past 5 years.\n* Using ginko bilboa (or unwilling to cease using it).\n* Current upper respiratory infections.\n* Use of narcotics (e.g. oxycodone, methadone).\n* Any prior history of amitryptiline use.\n* Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).\n* History of urinary retention.\n* Any history of major depressive disorder.\n* Any prior history of allergy to a tricyclic antidepressant.\n* Current diagnosis of gastroesophageal reflux (GERD).\n* 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).","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"64 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"J. Pieter Noordzij, MD","affiliation":"Boston Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","zip":"02118","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED","description":"No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Amitriptyline","description":"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"},{"id":"FG001","title":"Placebo","description":"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"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Amitriptyline","description":"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"},{"id":"BG001","title":"Placebo","description":"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"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"26"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45","spread":"15"},{"groupId":"BG001","value":"50","spread":"14"},{"groupId":"BG002","value":"48","spread":"15"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"15"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"15"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]}]}]},{"title":"Reflux Symptom Index (RSI) Score","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"severity on Likert-type scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19","spread":"10"},{"groupId":"BG001","value":"24","spread":"10"},{"groupId":"BG002","value":"22","spread":"9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Reflux Symptom Index","description":"Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes","populationDescription":"Patients who completed treatment and post-treatment questionnaire","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Amitriptyline","description":"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"},{"id":"OG001","title":"Placebo","description":"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"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.7","spread":"7.1"},{"groupId":"OG001","value":"0.3","spread":"12.0"}]}]}]},{"type":"SECONDARY","title":"Voice Handicap Index","description":"Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Amitriptyline","description":"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"},{"id":"OG001","title":"Placebo","description":"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"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.7","spread":"6.1"},{"groupId":"OG001","value":"0","spread":"4.3"}]}]}]},{"type":"SECONDARY","title":"Side Effects","description":"number of patients with side effects, type of side effects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Amitriptyline","description":"Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)\n\nAmitriptyline"},{"id":"OG001","title":"Placebo","description":"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)\n\nPlacebo: Placebo pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"}]}],"classes":[{"title":"Dizziness","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]}]},{"title":"Fatigue","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}]},{"title":"Dry mouth","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Lost to Follow up","populationDescription":"number of subjects in each arm who were lost to follow up","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Amitriptyline","description":"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"},{"id":"OG001","title":"Placebo","description":"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"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"1 year","description":"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\n\nFull definitions not listed due to character limit of 500","eventGroups":[{"id":"EG000","title":"Amitriptyline","description":"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","seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":6,"otherNumAtRisk":15},{"id":"EG001","title":"Placebo","description":"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","seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":2,"otherNumAtRisk":15}],"otherEvents":[{"term":"Adverse Effect","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Not an adverse event. Non-serious adverse effects include dizziness, fatigue, and dry mouth.","stats":[{"groupId":"EG000","numEvents":15,"numAffected":6,"numAtRisk":15},{"groupId":"EG001","numEvents":15,"numAffected":2,"numAtRisk":15}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Early termination leading to small numbers of subjects analyzed"},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Jacob Pieter Noordzij","organization":"Boston Medical Center","email":"Pieter.Noordzij@bmc.org","phone":"617-638-8124"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D007818","term":"Laryngeal Diseases"}],"ancestors":[{"id":"D012140","term":"Respiratory Tract Diseases"},{"id":"D010038","term":"Otorhinolaryngologic Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000639","term":"Amitriptyline"}],"ancestors":[{"id":"D003986","term":"Dibenzocycloheptenes"},{"id":"D001567","term":"Benzocycloheptenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}