{"protocolSection":{"identificationModule":{"nctId":"NCT00989157","orgStudyIdInfo":{"id":"F1J-US-X054"},"organization":{"fullName":"Neuropsychiatric Research Institute, Fargo, North Dakota","class":"OTHER"},"briefTitle":"Effects of Gastric Bypass on Blood Levels of Duloxetine","officialTitle":"A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine"},"statusModule":{"statusVerifiedDate":"2014-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-09"},"primaryCompletionDateStruct":{"date":"2012-10","type":"ACTUAL"},"completionDateStruct":{"date":"2012-11","type":"ACTUAL"},"studyFirstSubmitDate":"2009-10-01","studyFirstSubmitQcDate":"2009-10-01","studyFirstPostDateStruct":{"date":"2009-10-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-04-08","resultsFirstSubmitQcDate":"2014-07-17","resultsFirstPostDateStruct":{"date":"2014-08-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-07-17","lastUpdatePostDateStruct":{"date":"2014-08-11","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"James Roerig","investigatorTitle":"James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota","investigatorAffiliation":"Neuropsychiatric Research Institute, Fargo, North Dakota"},"leadSponsor":{"name":"Neuropsychiatric Research Institute, Fargo, North Dakota","class":"OTHER"},"collaborators":[{"name":"University of North Dakota","class":"OTHER"},{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender."},"conditionsModule":{"conditions":["Bariatric Surgery"],"keywords":["Gastric Bypass","Duloxetine","Cymbalta","Pharmacokinetics"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":20,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Active drug","type":"EXPERIMENTAL","description":"All subjects received drug. Single arm.","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"Single dose of 60 mg of duloxetine","armGroupLabels":["Active drug"],"otherNames":["Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Cmax","description":"The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72"},{"measure":"Tmax","description":"Time to maximum plasma concentration","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72"},{"measure":"AUCo-inf,","description":"Area under the plasma concentration time curve","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72"},{"measure":"T1/2","description":"Half life","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72"}],"secondaryOutcomes":[{"measure":"Emesis","description":"episodes of emesis.","timeFrame":"4 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female subjects between the ages of 18 and 60 years.\n* Subjects must be of good general health by history and physical exam.\n* Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement.\n* Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex.\n* Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.\n* No contraindications to receiving a single capsule of 60 mg of duloxetine\n\nExclusion Criteria:\n\n* Allergy to duloxetine or any of its constituents.\n* Candidates who are pregnant or nursing\n* Candidates currently receiving any antidepressant.\n* Candidates that are determined to be poor metabolizers for CYP2D6\n* Subjects who smoke or use any nicotine products\n* Candidates currently receiving a medication that interacts with duloxetine.\n* Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.\n* Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery\n* Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.\n* Candidates who have participated in an investigational drug study in past 30 days.\n* Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"James L Roerig, PharmD, BCPP","affiliation":"Neuropsychiatric Research Institute and University of North Dakota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Neuropsychiatric Research Institute","city":"Fargo","state":"North Dakota","zip":"58103","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Control","description":"Matched to bariatric subject via BMI, age and gender"},{"id":"FG001","title":"Bariatric","description":"One year post surgery"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Available Bariatric surgery candidates and pilot study results.","groups":[{"id":"BG000","title":"Bariatric","description":"Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP"},{"id":"BG001","title":"Control","description":"Subjects matched to the bariatric subjects via BMI, age and gender"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.10","spread":"9.02"},{"groupId":"BG001","value":"45.9","spread":"8.54"},{"groupId":"BG002","value":"45","spread":"8.78"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"18"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Cmax","description":"The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/ml","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72","groups":[{"id":"OG000","title":"Bariatric","description":"Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP"},{"id":"OG001","title":"Control","description":"Subjects matched to the bariatric subjects via BMI, age and gender"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.04","spread":"11.88"},{"groupId":"OG001","value":"61.41","spread":"34.93"}]}]}]},{"type":"SECONDARY","title":"Emesis","description":"episodes of emesis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"number of occurences","timeFrame":"4 days","groups":[{"id":"OG000","title":"Bariatric","description":"Subjects one year post surgery"},{"id":"OG001","title":"Control","description":"Subjects matched to the bariatric subjects via BMI, age and gender."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"PRIMARY","title":"Tmax","description":"Time to maximum plasma concentration","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Hours","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72","groups":[{"id":"OG000","title":"Bariatric","description":"Subjects one year post surgery"},{"id":"OG001","title":"Control","description":"Subjects matched to the bariatric subjects via BMI, age and gender."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"0.86"},{"groupId":"OG001","value":"6","spread":"2.17"}]}]}]},{"type":"PRIMARY","title":"AUCo-inf,","description":"Area under the plasma concentration time curve","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng h/mL","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72","groups":[{"id":"OG000","title":"Bariatric","description":"Subjects one year post surgery"},{"id":"OG001","title":"Control","description":"Subjects matched to the bariatric subjects via BMI, age and gender."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"646.74","spread":"79.70"},{"groupId":"OG001","value":"1119.91","spread":"593.40"}]}]}]},{"type":"PRIMARY","title":"T1/2","description":"Half life","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hours","timeFrame":"0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72","groups":[{"id":"OG000","title":"Bariatric","description":"Subjects one year post surgery"},{"id":"OG001","title":"Control","description":"Subjects matched to the bariatric subjects via BMI, age and gender."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.0","spread":"0.87"},{"groupId":"OG001","value":"11.75","spread":"2.38"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Bariatric","description":"Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":2,"otherNumAtRisk":10},{"id":"EG001","title":"Control","description":"Subjects matched to the bariatric subjects via BMI, age and gender","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":3,"otherNumAtRisk":10}],"otherEvents":[{"term":"Emesis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"Emesis","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Emesis post drug ingestion","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":10},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":10}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. James Roerig","organization":"NRIFargo","email":"jroerig@nrifargo.com","phone":"701 365 4919"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D000068736","term":"Duloxetine Hydrochloride"}],"ancestors":[{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}