{"protocolSection":{"identificationModule":{"nctId":"NCT00641719","orgStudyIdInfo":{"id":"12194"},"secondaryIdInfos":[{"id":"F1J-JE-HMFY","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Long-term Study for the Treatment of Painful Diabetic Neuropathy","officialTitle":"A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase"},"statusModule":{"statusVerifiedDate":"2011-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-03"},"primaryCompletionDateStruct":{"date":"2010-03","type":"ACTUAL"},"completionDateStruct":{"date":"2010-03","type":"ACTUAL"},"studyFirstSubmitDate":"2008-03-19","studyFirstSubmitQcDate":"2008-03-21","studyFirstPostDateStruct":{"date":"2008-03-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-03-03","resultsFirstSubmitQcDate":"2011-03-03","resultsFirstPostDateStruct":{"date":"2011-03-31","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-03-03","lastUpdatePostDateStruct":{"date":"2011-03-31","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Chief Medical Officer","oldOrganization":"Eli Lilly"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"},"collaborators":[{"name":"Shionogi","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use."},"conditionsModule":{"conditions":["Diabetic Neuropathies"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":258,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine 40 mg","type":"EXPERIMENTAL","description":"Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year","interventionNames":["Drug: Duloxetine hydrochloride"]},{"label":"Duloxetine 60 mg","type":"EXPERIMENTAL","description":"Duloxetine 60 mg QD, PO, 1 year","interventionNames":["Drug: Duloxetine hydrochloride"]}],"interventions":[{"type":"DRUG","name":"Duloxetine hydrochloride","description":"Duloxetine 40 mg QD, PO, 1 year","armGroupLabels":["Duloxetine 40 mg"],"otherNames":["LY248686","Cymbalta"]},{"type":"DRUG","name":"Duloxetine hydrochloride","description":"Duloxetine 60 mg QD, PO, 1 year","armGroupLabels":["Duloxetine 60 mg"],"otherNames":["LY248686","Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Experienced an Adverse Event (AE)","description":"See the Reported Adverse Events section for details.","timeFrame":"baseline through 1 year"}],"secondaryOutcomes":[{"measure":"Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.","description":"A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).","timeFrame":"1 year"},{"measure":"Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale","description":"A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).","timeFrame":"baseline, 1 year"},{"measure":"Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint","description":"A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.","timeFrame":"1 year"},{"measure":"Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores","description":"A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.","timeFrame":"baseline, 1 year"},{"measure":"Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint","description":"Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).","timeFrame":"1 year"},{"measure":"Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores","description":"Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).","timeFrame":"baseline, 1 year"},{"measure":"Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint","description":"A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.","timeFrame":"1 year"},{"measure":"Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score","description":"A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.","timeFrame":"baseline, 1 year"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).\n* Patients who desire to receive continued treatment with LY248686 from the preceding study.\n* Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.\n* Patients who can provide written consent in person.\n\nExclusion Criteria:\n\n* Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.\n* Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.\n* Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aichi","country":"Japan","geoPoint":{"lat":32.51879,"lon":130.62158}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aomori","country":"Japan","geoPoint":{"lat":40.81667,"lon":140.73333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chiba","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fukui","country":"Japan","geoPoint":{"lat":34.84214,"lon":135.54836}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fukuoka","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fukushima","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Gunma","country":"Japan"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hiroshima","country":"Japan","geoPoint":{"lat":34.4,"lon":132.45}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hokkaido","country":"Japan"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hyōgo","country":"Japan","geoPoint":{"lat":43.36667,"lon":144.43333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ibaraki","country":"Japan","geoPoint":{"lat":34.81641,"lon":135.56828}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kagoshima","country":"Japan","geoPoint":{"lat":31.56667,"lon":130.55}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kanagawa","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kyoto","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Miyagi","country":"Japan","geoPoint":{"lat":26.62566,"lon":128.18236}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Niigata","country":"Japan","geoPoint":{"lat":37.92259,"lon":139.04125}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Okayama","country":"Japan","geoPoint":{"lat":34.65,"lon":133.93333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Osaka","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ōita","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saitama","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Shizuoka","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tochigi","country":"Japan","geoPoint":{"lat":36.38333,"lon":139.73333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tokushima","country":"Japan","geoPoint":{"lat":34.06667,"lon":134.56667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tokyo","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Toyama","country":"Japan","geoPoint":{"lat":36.7,"lon":137.21667}}]},"referencesModule":{"references":[{"pmid":"26816607","type":"DERIVED","citation":"Yasuda H, Hotta N, Kasuga M, Kashiwagi A, Kawamori R, Yamada T, Baba Y, Alev L, Nakajo K. Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: Results from a randomized, 52-week, open-label study. J Diabetes Investig. 2016 Jan;7(1):100-8. doi: 10.1111/jdi.12361. Epub 2015 May 18."}],"seeAlsoLinks":[{"label":"Lilly Clinical Trial Registry","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Prior to start of extension study (HMFY), all participants in Study HMFX were re-randomized to duloxetine 40 or 60 mg regardless of the treatment they received in Study HMFX. Baseline values for the extension study HMFY represent those of 40- and 60-mg groups after re-randomization of participants.","recruitmentDetails":"This study, F1J-JE-HMFY (Study HMFY), is an open-label, long-term extension study of double-blind placebo-controlled study F1J-JE-HMFX (Study HMFX) (NCT00552175).","groups":[{"id":"FG000","title":"Duloxetine 40 mg","description":"Duloxetine 40 mg once daily (QD), orally (PO), 1 year"},{"id":"FG001","title":"Duloxetine 60 mg","description":"Duloxetine 60 mg QD, PO, 1 year"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"129"},{"groupId":"FG001","numSubjects":"129"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","comment":"1 participant discontinued during taper phase, not during treatment phase.","numSubjects":"92"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"37"}]}],"dropWithdraws":[{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"29"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Reason Not Specified","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine 40 mg","description":"Duloxetine 40 mg once daily (QD), orally (PO), 1 year"},{"id":"BG001","title":"Duloxetine 60 mg","description":"Duloxetine 60 mg QD, PO, 1 year"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"129"},{"groupId":"BG001","value":"129"},{"groupId":"BG002","value":"258"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.2","spread":"10.5"},{"groupId":"BG001","value":"60.0","spread":"9.6"},{"groupId":"BG002","value":"60.1","spread":"10.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"62"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"89"},{"groupId":"BG001","value":"107"},{"groupId":"BG002","value":"196"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"All participants were Japanese.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"129"},{"groupId":"BG001","value":"129"},{"groupId":"BG002","value":"258"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"129"},{"groupId":"BG001","value":"129"},{"groupId":"BG002","value":"258"}]}]}]},{"title":"Duration of Diabetes","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Less Than 5 Years","categories":[{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"48"}]}]},{"title":"5 to 10 Years","categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"50"}]}]},{"title":"Greater Than or Equal to 10 Years","categories":[{"measurements":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"155"}]}]},{"title":"Unknown","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]}]},{"title":"Type of Diabetes","description":"Type I diabetes is insulin dependent diabetes. Type II diabetes is non-insulin dependent diabetes.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Type I","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"12"}]}]},{"title":"Type II","categories":[{"measurements":[{"groupId":"BG000","value":"121"},{"groupId":"BG001","value":"125"},{"groupId":"BG002","value":"246"}]}]}]},{"title":"Height","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"centimeters (cm)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"163.69","spread":"9.04"},{"groupId":"BG001","value":"165.12","spread":"7.75"},{"groupId":"BG002","value":"164.41","spread":"8.44"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilograms (kg)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"63.91","spread":"12.13"},{"groupId":"BG001","value":"64.98","spread":"11.57"},{"groupId":"BG002","value":"64.45","spread":"11.84"}]}]}]},{"title":"Body Mass Index (BMI)","description":"Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared (kg/m\\^2).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilograms/meters squared (kg/m^2)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"23.79","spread":"3.77"},{"groupId":"BG001","value":"23.77","spread":"3.49"},{"groupId":"BG002","value":"23.78","spread":"3.62"}]}]}]},{"title":"Duration of Diabetic Neuropathy","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.91","spread":"3.16"},{"groupId":"BG001","value":"4.29","spread":"3.91"},{"groupId":"BG002","value":"4.10","spread":"3.55"}]}]}]},{"title":"Patient's Global Impressions of Improvement (PGI-I) Rate","description":"A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.0","spread":"1.1"},{"groupId":"BG001","value":"3.1","spread":"1.1"},{"groupId":"BG002","value":"3.1","spread":"1.1"}]}]}]},{"title":"Beck Depression Inventory - II (BDI-II)","description":"A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.1","spread":"6.4"},{"groupId":"BG001","value":"6.1","spread":"6.4"},{"groupId":"BG002","value":"6.1","spread":"6.4"}]}]}]},{"title":"Brief Pain Inventory (BPI) Interference","description":"Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. 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