{"protocolSection":{"identificationModule":{"nctId":"NCT02260388","orgStudyIdInfo":{"id":"STUDY00001500"},"secondaryIdInfos":[{"id":"PCORI-1306-02496","type":"OTHER_GRANT","domain":"Patient-Centered Outcomes Research Institute"}],"organization":{"fullName":"University of Kansas Medical Center","class":"OTHER"},"briefTitle":"Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations","officialTitle":"Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)","acronym":"PAIN-CONTRoLS"},"statusModule":{"statusVerifiedDate":"2018-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-09","type":"ACTUAL"},"completionDateStruct":{"date":"2017-09","type":"ACTUAL"},"studyFirstSubmitDate":"2014-10-06","studyFirstSubmitQcDate":"2014-10-08","studyFirstPostDateStruct":{"date":"2014-10-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-03-02","resultsFirstSubmitQcDate":"2018-06-06","resultsFirstPostDateStruct":{"date":"2018-07-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-06-06","lastUpdatePostDateStruct":{"date":"2018-07-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Kansas Medical Center","class":"OTHER"},"collaborators":[{"name":"Patient-Centered Outcomes Research Institute","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of the University of Kansas Medical Center, is to learn about the safety and effectiveness of nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN).","detailedDescription":"The goal of this research project is to find the best drug for the treatment of pain in patients with CSPN. While the pharmaceutical industry has focused attention on drugs for treating diabetic sensory neuropathy (DSPN), and two drugs are now FDA approved, there have not been any prospective trials in CSPN. And, because there are no studies with CSPN patients, insurance carriers often reject authorizing prescriptions for some drugs for patients with CSPN.\n\nThere are four drugs that will be tested in this study: nortriptyline, duloxetine, pregabalin and mexiletine. These drugs are not approved by the FDA for the treatment of CSPN and are considered \"investigational\" in this study.\n\nThere are two periods in this study: Screening/Baseline and Study Drug. During the Screening/Baseline period the researchers will determine eligibility for potential subjects. During the second period, eligible patients who consented to participate will take the study drug. Participants will be randomized to receive one of the four drugs in this study. Participants will know which drug they are taking. Participants will not be allowed to switch groups and receive a different drug during the study.\n\nThis study uses an adaptive study design. This means the study can enroll less participants and provide better conclusions. The study design allows the researchers the ability to make changes to the approach of the study or to stop the study early if there are strong results."},"conditionsModule":{"conditions":["Cryptogenic Sensory Polyneuropathy"],"keywords":["CSPN","neuropathy","pain","pain management"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":402,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Nortriptyline","type":"EXPERIMENTAL","description":"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.","interventionNames":["Drug: Nortriptyline"]},{"label":"Duloxetine","type":"EXPERIMENTAL","description":"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.","interventionNames":["Drug: Duloxetine"]},{"label":"Pregabalin","type":"EXPERIMENTAL","description":"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.","interventionNames":["Drug: Pregabalin"]},{"label":"Mexiletine","type":"EXPERIMENTAL","description":"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.","interventionNames":["Drug: Mexiletine"]}],"interventions":[{"type":"DRUG","name":"Nortriptyline","armGroupLabels":["Nortriptyline"]},{"type":"DRUG","name":"Duloxetine","armGroupLabels":["Duloxetine"]},{"type":"DRUG","name":"Pregabalin","armGroupLabels":["Pregabalin"]},{"type":"DRUG","name":"Mexiletine","armGroupLabels":["Mexiletine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit","description":"The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions.","timeFrame":"12 weeks"}],"secondaryOutcomes":[{"measure":"SF12 Health Composite Scores","description":"SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view.\n\nSurvey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.\n\nScores are calibrated so that 50 is the average score or norm, standard deviation = 10.\n\nHigher scores indicate better health for both mental and physical component summary scores.","timeFrame":"12 weeks"},{"measure":"PROMIS Pain Interference Short Form v1.0 8a T Score","description":"Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.\n\nOn the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.","timeFrame":"12 weeks"},{"measure":"PROMIS Fatigue Short Form v1.0 8a","description":"Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.\n\nOn the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.","timeFrame":"12 Weeks"},{"measure":"PROMIS Sleep Disturbance Short Form v1.0 8a","description":"Higher scores for sleep disturbance represents worse outcome (more sleep disturbance).\n\nT-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.\n\nOn the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.\n\nHigher scores equals more of the concept being measured","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of cryptogenic sensory polyneuropathy.\n* Likert Pain Score of greater than or equal to 4.\n* Must not currently be on nortriptyline, duloxetine, pregabalin or mexiletine or similar class of medication for at least 7 days from baseline study visit.\n\nExclusion Criteria:\n\n* Any medical condition or current medication that would prevent them from taking either nortriptyline, duloxetine, pregabalin or mexiletine.\n* Unable to give consent.\n* Unable or not willing to comply with the study.\n* Other causes for polyneuropathy.","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Richard Barohn, MD","affiliation":"University of Kansas Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Barrow Neurological Institute","city":"Phoenix","state":"Arizona","zip":"85013","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Phoenix Neurological Associates","city":"Phoenix","state":"Arizona","zip":"85018","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","zip":"90048","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"California Pacific Medical Center","city":"San Francisco","state":"California","zip":"94107","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","zip":"94143","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"University of Colorado Denver Anschutz Campus","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Colorado Springs Neurological Associates","city":"Colorado Springs","state":"Colorado","zip":"80907","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"University of Florida - Gainesville","city":"Gainesville","state":"Florida","zip":"10236","country":"United States","geoPoint":{"lat":29.65163,"lon":-82.32483}},{"facility":"University of Florida Health Science Center - Jacksonville","city":"Jacksonville","state":"Florida","zip":"32209","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"University of Miami Miller School of Medicine","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Neurological Services of Orlando Research","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"University of South Florida","city":"Tampa","state":"Florida","zip":"33612","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"NorthShore Neurological Institute","city":"Glenview","state":"Illinois","zip":"60026","country":"United States","geoPoint":{"lat":42.06975,"lon":-87.78784}},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","zip":"46202","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Mercy Medical Center - Des Moines","city":"Des Moines","state":"Iowa","zip":"50314","country":"United States","geoPoint":{"lat":41.60054,"lon":-93.60911}},{"facility":"University of Iowa Hospitals and Clinics","city":"Iowa City","state":"Iowa","zip":"52242","country":"United States","geoPoint":{"lat":41.66113,"lon":-91.53017}},{"facility":"Hutchinson Clinic, PA","city":"Hutchinson","state":"Kansas","zip":"67502","country":"United States","geoPoint":{"lat":38.06084,"lon":-97.92977}},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","zip":"66160","country":"United States","geoPoint":{"lat":39.11417,"lon":-94.62746}},{"facility":"Norton Neurology Services","city":"Louisville","state":"Kentucky","zip":"40207","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","zip":"02115","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","zip":"48105","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","zip":"48202","country":"United States","geoPoint":{"lat":42.33143,"lon":-83.04575}},{"facility":"Spectrum Health System","city":"Grand Rapids","state":"Michigan","zip":"49525","country":"United States","geoPoint":{"lat":42.96336,"lon":-85.66809}},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","zip":"55414","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"Saint Louis University","city":"St Louis","state":"Missouri","zip":"63103","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","zip":"68198","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"University of Buffalo School of Medicine and Biomedical Sciences","city":"Buffalo","state":"New York","zip":"14203","country":"United States","geoPoint":{"lat":42.88645,"lon":-78.87837}},{"facility":"Mount Sinai Beth Israel","city":"New York","state":"New York","zip":"10029","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","zip":"45221","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","zip":"44195","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"The Ohio State University Wexner Medical Center","city":"Columbus","state":"Ohio","zip":"43210","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","zip":"97239","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Penn State Medical Center","city":"Hershey","state":"Pennsylvania","zip":"17033","country":"United States","geoPoint":{"lat":40.28592,"lon":-76.65025}},{"facility":"Austin Neuromuscular Center","city":"Austin","state":"Texas","zip":"78703","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Sara Austin, MD, PA","city":"Austin","state":"Texas","zip":"78705","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Seton Brain and Spine Institute","city":"Austin","state":"Texas","zip":"78705","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Texas Neurology","city":"Dallas","state":"Texas","zip":"75214","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"University of Texas Southwestern","city":"Dallas","state":"Texas","zip":"75390","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"University of Texas Health Science Center at Houton","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Grand Medical Clinic","city":"Katy","state":"Texas","zip":"77494","country":"United States","geoPoint":{"lat":29.78579,"lon":-95.8244}},{"facility":"Neurology Clinic of Central Texas","city":"New Braunfels","state":"Texas","zip":"78132","country":"United States","geoPoint":{"lat":29.703,"lon":-98.12445}},{"facility":"University of Texas Health Science Center in San Antonio","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","zip":"84112","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"University of Vermont Medical Center","city":"Burlington","state":"Vermont","zip":"05403","country":"United States","geoPoint":{"lat":44.47588,"lon":-73.21207}},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","zip":"22908","country":"United States","geoPoint":{"lat":38.02931,"lon":-78.47668}},{"facility":"Toronto General Hospital","city":"Toronto","state":"Ontario","zip":"M5G 2C4","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}}]},"referencesModule":{"references":[{"pmid":"32809014","type":"DERIVED","citation":"Barohn RJ, Gajewski B, Pasnoor M, Brown A, Herbelin LL, Kimminau KS, Mudaranthakam DP, Jawdat O, Dimachkie MM; Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS) Study Team; Iyadurai S, Stino A, Kissel J, Pascuzzi R, Brannagan T, Wicklund M, Ahmed A, Walk D, Smith G, Quan D, Heitzman D, Tobon A, Ladha S, Wolfe G, Pulley M, Hayat G, Li Y, Thaisetthawatkul P, Lewis R, Biliciler S, Sharma K, Salajegheh K, Trivedi J, Mallonee W, Burns T, Jacoby M, Bril V, Vu T, Ramchandren S, Bazant M, Austin S, Karam C, Hussain Y, Kutz C, Twydell P, Scelsa S, Kushlaf H, Wymer J, Hehir M, Kolb N, Ralph J, Barboi A, Verma N, Ahmed M, Memon A, Saperstein D, Lou JS, Swenson A, Cash T. Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial. JAMA Neurol. 2021 Jan 1;78(1):68-76. doi: 10.1001/jamaneurol.2020.2590."},{"pmid":"27577191","type":"DERIVED","citation":"Brown AR, Gajewski BJ, Aaronson LS, Mudaranthakam DP, Hunt SL, Berry SM, Quintana M, Pasnoor M, Dimachkie MM, Jawdat O, Herbelin L, Barohn RJ. A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization. Trials. 2016 Aug 31;17(1):428. doi: 10.1186/s13063-016-1544-5."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Nortriptyline","description":"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.\n\nNortriptyline"},{"id":"FG001","title":"Duloxetine","description":"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.\n\nDuloxetine"},{"id":"FG002","title":"Pregabalin","description":"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.\n\nPregabalin"},{"id":"FG003","title":"Mexiletine","description":"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.\n\nMexiletine"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"126"},{"groupId":"FG002","numSubjects":"73"},{"groupId":"FG003","numSubjects":"69"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"132"},{"groupId":"FG001","numSubjects":"118"},{"groupId":"FG002","numSubjects":"70"},{"groupId":"FG003","numSubjects":"65"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Nortriptyline","description":"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.\n\nNortriptyline"},{"id":"BG001","title":"Duloxetine","description":"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.\n\nDuloxetine"},{"id":"BG002","title":"Pregabalin","description":"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.\n\nPregabalin"},{"id":"BG003","title":"Mexiletine","description":"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.\n\nMexiletine"},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"134"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"73"},{"groupId":"BG003","value":"69"},{"groupId":"BG004","value":"402"}]}],"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"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"86"},{"groupId":"BG002","value":"50"},{"groupId":"BG003","value":"41"},{"groupId":"BG004","value":"268"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"28"},{"groupId":"BG004","value":"134"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.3","spread":"12.7"},{"groupId":"BG001","value":"59.9","spread":"14.0"},{"groupId":"BG002","value":"59.5","spread":"13.6"},{"groupId":"BG003","value":"60.7","spread":"13.7"},{"groupId":"BG004","value":"60.1","spread":"13.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"59"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"28"},{"groupId":"BG004","value":"189"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"39"},{"groupId":"BG003","value":"41"},{"groupId":"BG004","value":"213"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"21"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"126"},{"groupId":"BG001","value":"119"},{"groupId":"BG002","value":"68"},{"groupId":"BG003","value":"66"},{"groupId":"BG004","value":"379"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"17"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"26"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"104"},{"groupId":"BG002","value":"62"},{"groupId":"BG003","value":"64"},{"groupId":"BG004","value":"343"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"15"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"134"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"73"},{"groupId":"BG003","value":"69"},{"groupId":"BG004","value":"402"}]}]}]},{"title":"Patient-Reported Outcomes Measurement Information System (PROMIS) Scale T-Scores","description":"T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD). 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Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Norm-Based Standardization Score","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Nortriptyline","description":"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.\n\nNortriptyline"},{"id":"OG001","title":"Duloxetine","description":"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.\n\nDuloxetine"},{"id":"OG002","title":"Pregabalin","description":"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.\n\nPregabalin"},{"id":"OG003","title":"Mexiletine","description":"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.\n\nMexiletine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"79"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"29"}]}],"classes":[{"title":"Mental Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"51.0","spread":"8.9"},{"groupId":"OG001","value":"50.9","spread":"9.9"},{"groupId":"OG002","value":"47.2","spread":"11.2"},{"groupId":"OG003","value":"51.3","spread":"10.8"}]}]},{"title":"Physical Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"42.8","spread":"8.7"},{"groupId":"OG001","value":"42.1","spread":"9.5"},{"groupId":"OG002","value":"40.0","spread":"8.2"},{"groupId":"OG003","value":"43.7","spread":"9.6"}]}]}]},{"type":"SECONDARY","title":"PROMIS Pain Interference Short Form v1.0 8a T Score","description":"Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.\n\nOn the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.","populationDescription":"No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. 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Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"T-Score","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Nortriptyline","description":"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.\n\nNortriptyline"},{"id":"OG001","title":"Duloxetine","description":"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.\n\nDuloxetine"},{"id":"OG002","title":"Pregabalin","description":"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the 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