{"protocolSection":{"identificationModule":{"nctId":"NCT00619983","orgStudyIdInfo":{"id":"IRB00003943"},"secondaryIdInfos":[{"id":"5R01NS057594","type":"NIH","link":"https://reporter.nih.gov/quickSearch/5R01NS057594"}],"organization":{"fullName":"Wake Forest University Health Sciences","class":"OTHER"},"briefTitle":"Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy","officialTitle":"Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy"},"statusModule":{"statusVerifiedDate":"2018-08","overallStatus":"TERMINATED","whyStopped":"Study terminated due to low enrollment","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-02"},"primaryCompletionDateStruct":{"date":"2013-05","type":"ACTUAL"},"completionDateStruct":{"date":"2013-05","type":"ACTUAL"},"studyFirstSubmitDate":"2008-02-08","studyFirstSubmitQcDate":"2008-02-08","studyFirstPostDateStruct":{"date":"2008-02-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-07-11","resultsFirstSubmitQcDate":"2017-07-11","resultsFirstPostDateStruct":{"date":"2017-08-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-08-13","lastUpdatePostDateStruct":{"date":"2018-09-11","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Wake Forest University","class":"OTHER"},"collaborators":[{"name":"National Institute of Neurological Disorders and Stroke (NINDS)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).","detailedDescription":"Neuropathic pain is a complex and likely heterogeneous disorder, and we recognize that clinically useful agents such as opioids, gabapentin, and antidepressants may be effective precisely because they have multiple mechanisms of action at multiple sites. This study, however, will not only provide important mechanistic information regarding one cascade which can be manipulated for analgesia, but will also provide much needed systematic and practical guidance for multi-drug therapy in patients with neuropathic pain.\n\nThis study in patients with diabetic neuropathic pain and patients with failed low back syndrome, culminate in a quantitative description of interactions between activators of descending noradrenergic activity, norepinephrine transporter inhibitors, and cholinesterase inhibitors to exploit the plasticity of analgesia in chronic pain states. We will focus on practical applications, using clinically approved drugs, including gabapentin (Neurontin®) to activate noradrenergic activity, duloxetine (Cymbalta®) to inhibit the norepinephrine transporter, and donepezil (Aricept®), approved for the treatment of Alzheimer's dementia, but not previously tested to treat neuropathic pain, to inhibit cholinesterase.\n\nAfter the baseline measurements and physical examination patients will be trained to use a Personal Digital Assistant (PDA) to answer questions about their diabetic neuropathic pain or their chronic back pain. Upon successful completion of these tasks the patients will be randomized to receive one of the drug choices or placebo (inactive pill).\n\nThe study will last for a total of 16 weeks and includes 5 visits to the research center with each visit lasting approximately 2 hours."},"conditionsModule":{"conditions":["Diabetic Neuropathic Pain","Chronic Low Back Pain"],"keywords":["Asymmetric Diabetic Proximal Motor Neuropathy","Diabetic Autonomic Neuropathy","Diabetic Neuralgia","Diabetic Neuropathy, Painful","Neuralgia, Diabetic","Low back pain, chronic"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":22,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Donepezil","type":"ACTIVE_COMPARATOR","description":"Donepezil 5 mg once per day for 12 weeks. Gabapentin will be titrated in all groups beginning at week 8.","interventionNames":["Drug: donepezil","Drug: gabapentin"]},{"label":"Duloxetine","type":"ACTIVE_COMPARATOR","description":"Group 2: Will receive duloxetine 30 mg twice a day for 12 weeks. Gabapentin will be titrated in all groups beginning at week 8.","interventionNames":["Drug: duloxetine","Drug: gabapentin"]},{"label":"Donepezil + Duloxetine","type":"ACTIVE_COMPARATOR","description":"Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg for 12 weeks. Gabapentin will be titrated in all groups beginning at week 8.","interventionNames":["Drug: donepezil 2.5 mg and duloxetine 30mg","Drug: gabapentin"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Group 4:Will receive placebo pills. Gabapentin will be titrated in all groups beginning at week 8.","interventionNames":["Drug: placebo","Drug: gabapentin"]}],"interventions":[{"type":"DRUG","name":"donepezil","description":"Group 1: Will receive donepezil 5mg once a day","armGroupLabels":["Donepezil"],"otherNames":["Aricept®"]},{"type":"DRUG","name":"duloxetine","description":"Group 2: Will receive duloxetine 30 mg twice a day","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta®"]},{"type":"DRUG","name":"donepezil 2.5 mg and duloxetine 30mg","description":"Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg","armGroupLabels":["Donepezil + Duloxetine"],"otherNames":["Cymbalta®","Aricept®"]},{"type":"DRUG","name":"placebo","description":"Group 4: Will receive placebo pills","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"gabapentin","description":"Week 8: all subjects will have open label gabapentin added to their randomized study medication","armGroupLabels":["Donepezil","Donepezil + Duloxetine","Duloxetine","Placebo"],"otherNames":["neurontin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Visual Analog Scale for Pain","description":"The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as \"No pain at all\" and on the right as \"The worst pain imaginable\". The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone).","timeFrame":"Study completion (16 weeks)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of diabetic neuropathy\n* Age 18-80\n* Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon entry into the study\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy to study medications\n* Uncontrolled narrow-angle glaucoma\n* Currently being treatment with thioridazine (Mellaril)\n* Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases\n* Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"James C Eisenach, MD","affiliation":"Wake Forest University Health Sciences","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Wake Forest University Baptist Medical Center","city":"Winston-Salem","state":"North Carolina","zip":"27157","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","zip":"44195","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Raw IPD will not be shared"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Donepezil","description":"Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"FG001","title":"Duloxetine","description":"Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"FG002","title":"Donepezil + Duloxetine","description":"Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"FG003","title":"Placebo","description":"Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."}],"periods":[{"title":"Test Drug Alone","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Failure of daily diary device","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}]}]},{"title":"Test Drug Plus Gabapentin","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Gabapentin Alone","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Donepezil","description":"Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"BG001","title":"Duloxetine","description":"Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"BG002","title":"Donepezil + Duloxetine","description":"Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"BG003","title":"Placebo","description":"Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"22"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62","lowerLimit":"52","upperLimit":"65"},{"groupId":"BG001","value":"56","lowerLimit":"54","upperLimit":"60"},{"groupId":"BG002","value":"59","lowerLimit":"58","upperLimit":"59"},{"groupId":"BG003","value":"70","lowerLimit":"65","upperLimit":"72"},{"groupId":"BG004","value":"60","lowerLimit":"50","upperLimit":"72"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"8"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"14"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"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":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"7"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"15"}]},{"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":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"22"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Visual Analog Scale for Pain","description":"The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as \"No pain at all\" and on the right as \"The worst pain imaginable\". The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone).","populationDescription":"As noted in patient flow, data are available for only 14 of 22 subjects due to failure of the electronic daily diaries used to assess pain during the study and to study discontinuation in some cases","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"units on a scale","timeFrame":"Study completion (16 weeks)","groups":[{"id":"OG000","title":"Donepezil","description":"Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"OG002","title":"Donepezil + Duloxetine","description":"Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."},{"id":"OG003","title":"Placebo","description":"Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"}]}],"classes":[{"title":"Baseilne ( weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"3.3","lowerLimit":"2.0","upperLimit":"6.7"},{"groupId":"OG001","value":"6.4","lowerLimit":"2.3","upperLimit":"9.8"},{"groupId":"OG002","value":"5.8","lowerLimit":"3.6","upperLimit":"7.3"},{"groupId":"OG003","value":"4.9","lowerLimit":"4.5","upperLimit":"8.4"}]}]},{"title":"Test drug alone (6 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"4.1","lowerLimit":"1.5","upperLimit":"4.6"},{"groupId":"OG001","value":"2.9","lowerLimit":"1.6","upperLimit":"9.7"},{"groupId":"OG002","value":"5.2","lowerLimit":"4.3","upperLimit":"6.9"},{"groupId":"OG003","value":"3.9","lowerLimit":"2.4","upperLimit":"4.8"}]}]},{"title":"Drug plus gabapentin (6 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"2.9","lowerLimit":"0.4","upperLimit":"3.2"},{"groupId":"OG001","value":"2.7","lowerLimit":"1.1","upperLimit":"9.7"},{"groupId":"OG002","value":"3.9","lowerLimit":"3.5","upperLimit":"5.3"},{"groupId":"OG003","value":"4.1","lowerLimit":"1.1","upperLimit":"6.3"}]}]},{"title":"Gabapentin alone (2 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"2.2","lowerLimit":"0","upperLimit":"2.6"},{"groupId":"OG001","value":"3.0","lowerLimit":"2.4","upperLimit":"10"},{"groupId":"OG002","value":"4.3","lowerLimit":"3.3","upperLimit":"5.2"},{"groupId":"OG003","value":"4.1","lowerLimit":"1.9","upperLimit":"6.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit \\< 30% of the number of subjects required in our power analysis.","nonInferiorityType":"SUPERIORITY","pValue":"0.69","statisticalMethod":"ANOVA","statisticalComment":"Repeated measures ANOVA"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"During the 16 week study","eventGroups":[{"id":"EG000","title":"Donepezil","description":"Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.","deathsNumAffected":0,"deathsNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":1,"otherNumAtRisk":5},{"id":"EG001","title":"Duloxetine","description":"Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.","deathsNumAffected":0,"deathsNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":0,"otherNumAtRisk":5},{"id":"EG002","title":"Donepezil + Duloxetine","description":"Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.","deathsNumAffected":0,"deathsNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"otherNumAffected":0,"otherNumAtRisk":6},{"id":"EG003","title":"Placebo","description":"Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.","deathsNumAffected":0,"deathsNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"otherNumAffected":1,"otherNumAtRisk":6}],"seriousEvents":[{"term":"Angina","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Subject experienced chest pain and was hospitalized. Serial ECGs and troponins were negative for myocardial injury","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":6}]}],"otherEvents":[{"term":"nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"subject experienced nausea","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"osteomyelitis","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"subject experienced osteomyelitis of of second phalange","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":5},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":5},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":6}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"We recruited only a small proportion of the planned enrollment in the period of grant funding, leading to early termination of the study. Also, the failure of the electronic diaries and loss of primary outcome data prevented the planned analysis."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. James Eisenach","organization":"Wake Forest School of Medicine","email":"jimeisenach@gmail.com","phone":"336-716-4182"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2010-10-19","uploadDate":"2017-08-10T10:28","filename":"Prot_SAP_000.pdf","size":326789},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2010-04-16","uploadDate":"2017-08-10T10:28","filename":"ICF_001.pdf","size":290706}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003929","term":"Diabetic Neuropathies"},{"id":"D017116","term":"Low Back Pain"},{"id":"D000092122","term":"Bronchiolitis Obliterans Syndrome"}],"ancestors":[{"id":"D010523","term":"Peripheral Nervous System Diseases"},{"id":"D009468","term":"Neuromuscular Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D048909","term":"Diabetes Complications"},{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D001416","term":"Back Pain"},{"id":"D010146","term":"Pain"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D000092124","term":"Organizing Pneumonia"},{"id":"D001989","term":"Bronchiolitis Obliterans"},{"id":"D001988","term":"Bronchiolitis"},{"id":"D001991","term":"Bronchitis"},{"id":"D001982","term":"Bronchial Diseases"},{"id":"D012140","term":"Respiratory Tract Diseases"},{"id":"D008173","term":"Lung Diseases, Obstructive"},{"id":"D008171","term":"Lung Diseases"},{"id":"D006086","term":"Graft vs Host Disease"},{"id":"D007154","term":"Immune System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077265","term":"Donepezil"},{"id":"D000068736","term":"Duloxetine Hydrochloride"},{"id":"D000077206","term":"Gabapentin"}],"ancestors":[{"id":"D007189","term":"Indans"},{"id":"D007192","term":"Indenes"},{"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":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D000588","term":"Amines"},{"id":"D005680","term":"gamma-Aminobutyric Acid"},{"id":"D000613","term":"Aminobutyrates"},{"id":"D002087","term":"Butyrates"},{"id":"D000144","term":"Acids, Acyclic"},{"id":"D002264","term":"Carboxylic Acids"},{"id":"D003509","term":"Cyclohexanecarboxylic Acids"},{"id":"D000146","term":"Acids, Carbocyclic"},{"id":"D003510","term":"Cyclohexanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D000596","term":"Amino Acids"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"}]}},"hasResults":true}