{ "FullStudy":{ "Rank":217752, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517295", "OrgStudyIdInfo":{ "OrgStudyId":"NEMA-HydrocodonePK-001" }, "Organization":{ "OrgFullName":"NEMA Research, Inc.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients", "OfficialTitle":"Evaluating the Pharmacokinetic Profile of Hydromorphone in Chronic Pain Patients Taking Hydrocodone/APAP" }, "StatusModule":{ "StatusVerifiedDate":"June 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 4, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 4, 2016", "ResultsFirstSubmitQCDate":"June 17, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 28, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 17, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 28, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"NEMA Research, Inc.", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Medtronic - MITG", "CollaboratorClass":"INDUSTRY" },{ "CollaboratorName":"International Clinical Research Institute", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.", "DetailedDescription":"Hydrocodone combinations are the most commonly prescribed pain medications in the United States. All the current available Hydrocodone formulations are short acting and have Acetaminophen/Ibuprofen in them. Chronic pain patients who take pain medications for extended time are overloaded with Acetaminophen and there is a very serious concern about liver failure from excessive concurrent alcohol use. Also all the current hydrocodone combinations available in the U.S. are short acting and provide pain relief for 3-6 hrs.\n\nHydromorphone is a metabolite of Hydrocodone and plays a significant role in providing pain relief in these patients. Although there are no long acting or extended release hydrocodone formulations that are FDA approve at this time, there is once a day extended release Hydromorphone (ER) approved by FDA and is currently marketed under the name Exalgo ®. PK study of chronic hydrocodone/acetaminophen usage is important to determine equivalent potency with hydromorphone ER, so that clinicians can use a simple conversion formula to switch to hydromorphone ER.\n\nAlthough medical professionals use the Opiate conversion formula on a regular basis for Opioid rotation, there are no published studies showing the pharmacokinetic data in patients taking hydrocodone for chronic pain.\n\nOur goal is to use this PK data to guide clinicians with this data in using extended release hydromorphone for chronic pain management to provide predictable pain relief and minimize the acetaminophen usage." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chronic Pain" ] }, "KeywordList":{ "Keyword":[ "Pharmacokinetics", "Hydromorphone", "Hydrocodone", "APAP" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"30", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Group 1", "ArmGroupType":"Experimental", "ArmGroupDescription":"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Hydrocodone" ] } },{ "ArmGroupLabel":"Group 2", "ArmGroupType":"Experimental", "ArmGroupDescription":"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Hydrocodone" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Hydrocodone", "InterventionDescription":"Dose: Standard prescribed dose Frequency: Once Duration: Once", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group 1", "Group 2" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Hydrocodone/APAP", "Vicodin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Peak Plasma Concentration of Hydromorphone", "PrimaryOutcomeDescription":"Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.", "PrimaryOutcomeTimeFrame":"Up to 6 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Correlation of Plasma PK of Hydrocodone", "SecondaryOutcomeDescription":"Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.", "SecondaryOutcomeTimeFrame":"1 Month" },{ "SecondaryOutcomeMeasure":"Peak Urine Concentration of Hydromorphone", "SecondaryOutcomeDescription":"Analyze the urine concentration of hydromorphone", "SecondaryOutcomeTimeFrame":"Up to 4 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMan or woman aged 18-75\nDocumented clinical diagnosis of chronic pain.\nHave been taking hydrocodone/APAP for their chronic non-cancer pain.\nSubjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.\nSubjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\nSubjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.\nHealth concerns that the study physician feels may confound study results.\nIndividuals who are cognitively impaired or who are not able to give informed consent.\nPrevious participation in a clinical research trial within 30 days prior to randomization.\nThe subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Srinivas Nalamachu, MD", "OverallOfficialAffiliation":"International Clinical Research Institute", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Joseph Pergolizzi, MD", "OverallOfficialAffiliation":"NEMA Research, Inc.", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"NEMA Research Inc. (CRO)", "LocationCity":"Naples", "LocationState":"Florida", "LocationZip":"34108", "LocationCountry":"United States" },{ "LocationFacility":"International Clinical Research Institute", "LocationCity":"Leawood", "LocationState":"Kansas", "LocationZip":"66211", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"11499035", "ReferenceType":"background", "ReferenceCitation":"Wu Y. [Studies on the analysis of hydrocodone and its metabolite in human urine by GC/MS]. Yao Xue Xue Bao. 1997 Apr;32(4):305-9. Chinese." },{ "ReferencePMID":"11936695", "ReferenceType":"background", "ReferenceCitation":"Chen YL, Hanson GD, Jiang X, Naidong W. Simultaneous determination of hydrocodone and hydromorphone in human plasma by liquid chromatography with tandem mass spectrometric detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Mar 25;769(1):55-64." },{ "ReferencePMID":"12535841", "ReferenceType":"background", "ReferenceCitation":"Menelaou A, Hutchinson MR, Quinn I, Christensen A, Somogyi AA. Quantification of the O- and N-demethylated metabolites of hydrocodone and oxycodone in human liver microsomes using liquid chromatography with ultraviolet absorbance detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Feb 25;785(1):81-8." },{ "ReferencePMID":"14998425", "ReferenceType":"background", "ReferenceCitation":"Hutchinson MR, Menelaou A, Foster DJ, Coller JK, Somogyi AA. CYP2D6 and CYP3A4 involvement in the primary oxidative metabolism of hydrocodone by human liver microsomes. Br J Clin Pharmacol. 2004 Mar;57(3):287-97." },{ "ReferencePMID":"37301", "ReferenceType":"background", "ReferenceCitation":"Cone EJ, Darwin WD, Gorodetzky CW. Comparative metabolism of codeine in man, rat, dog, guinea-pig and rabbit: identification of four new metabolites. J Pharm Pharmacol. 1979 May;31(5):314-7." },{ "ReferencePMID":"7693389", "ReferenceType":"background", "ReferenceCitation":"Otton SV, Schadel M, Cheung SW, Kaplan HL, Busto UE, Sellers EM. CYP2D6 phenotype determines the metabolic conversion of hydrocodone to hydromorphone. Clin Pharmacol Ther. 1993 Nov;54(5):463-72." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Group 1", "FlowGroupDescription":"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Group 2", "FlowGroupDescription":"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Group 1", "BaselineGroupDescription":"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Group 2", "BaselineGroupDescription":"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"30" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"43.63", "BaselineMeasurementSpread":"8.937" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"54.28", "BaselineMeasurementSpread":"8.279" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"48.60", "BaselineMeasurementSpread":"10.062" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"21" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Not Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"29" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"28" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"30" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Peak Plasma Concentration of Hydromorphone", "OutcomeMeasureDescription":"Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"Up to 6 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group 1", "OutcomeGroupDescription":"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group 2", "OutcomeGroupDescription":"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Hour 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hour 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No blood drawn at this time point" } ] } } ] } },{ "OutcomeClassTitle":"Hour 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No blood drawn at this time point" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hour 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No blood drawn at this time point" } ] } } ] } },{ "OutcomeClassTitle":"Hour 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No blood drawn at this time point" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hour 5", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No blood drawn at this time point" } ] } } ] } },{ "OutcomeClassTitle":"Hour 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No blood drawn at this time point" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Correlation of Plasma PK of Hydrocodone", "OutcomeMeasureDescription":"Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.", "OutcomeMeasurePopulationDescription":"Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"1 Month", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group 1", "OutcomeGroupDescription":"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group 2", "OutcomeGroupDescription":"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Peak Urine Concentration of Hydromorphone", "OutcomeMeasureDescription":"Analyze the urine concentration of hydromorphone", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"Up to 4 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group 1", "OutcomeGroupDescription":"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group 2", "OutcomeGroupDescription":"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Hour 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"726.69", "OutcomeMeasurementSpread":"1294.77" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"211.36", "OutcomeMeasurementSpread":"248.356" } ] } } ] } },{ "OutcomeClassTitle":"Hour 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"815.63", "OutcomeMeasurementSpread":"1396.38" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No urine was taken at this time point." } ] } } ] } },{ "OutcomeClassTitle":"Hour 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"No urine was taken at this time point." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"205.57", "OutcomeMeasurementSpread":"239.508" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"From time of first dose of Hydrocodone to Completion of study.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Group 1", "EventGroupDescription":"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG001", "EventGroupTitle":"Group 2", "EventGroupDescription":"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.\n\nHydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"14", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"14" } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Srinivas Nalamachu", "PointOfContactOrganization":"International Clinical Research Institute", "PointOfContactEMail":"nalamachu@yahoo.com", "PointOfContactPhone":"913.317.5300" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000006853", "InterventionMeshTerm":"Hydrocodone" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000701", "InterventionAncestorTerm":"Analgesics, Opioid" },{ "InterventionAncestorId":"D000009294", "InterventionAncestorTerm":"Narcotics" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000000996", "InterventionAncestorTerm":"Antitussive Agents" },{ "InterventionAncestorId":"D000019141", "InterventionAncestorTerm":"Respiratory System Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M233133", "InterventionBrowseLeafName":"Acetaminophen, hydrocodone drug combination", "InterventionBrowseLeafRelevance":"low" },{ 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