Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 8:29 AM
Study NCT ID:
NCT01517295
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2012-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006853', 'term': 'Hydrocodone'}, {'id': 'C083640', 'term': 'acetaminophen, hydrocodone drug combination'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nalamachu@yahoo.com', 'phone': '913.317.5300', 'title': 'Srinivas Nalamachu', 'organization': 'International Clinical Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'From time of first dose of Hydrocodone to Completion of study.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': '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', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': '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', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Plasma Concentration of Hydromorphone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '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'}, {'id': 'OG001', 'title': 'Group 2', 'description': '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'}], 'classes': [{'title': 'Hour 0', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hour 1', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No blood drawn at this time point', 'groupId': 'OG001'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No blood drawn at this time point', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hour 3', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No blood drawn at this time point', 'groupId': 'OG001'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No blood drawn at this time point', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hour 5', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No blood drawn at this time point', 'groupId': 'OG001'}]}]}, {'title': 'Hour 6', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No blood drawn at this time point', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 hours', 'description': '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation of Plasma PK of Hydrocodone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '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'}, {'id': 'OG001', 'title': 'Group 2', 'description': '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'}], 'timeFrame': '1 Month', 'description': 'Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.'}, {'type': 'SECONDARY', 'title': 'Peak Urine Concentration of Hydromorphone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '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'}, {'id': 'OG001', 'title': 'Group 2', 'description': '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'}], 'classes': [{'title': 'Hour 0', 'categories': [{'measurements': [{'value': '726.69', 'spread': '1294.77', 'groupId': 'OG000'}, {'value': '211.36', 'spread': '248.356', 'groupId': 'OG001'}]}]}, {'title': 'Hour 3', 'categories': [{'measurements': [{'value': '815.63', 'spread': '1396.38', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No urine was taken at this time point.', 'groupId': 'OG001'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No urine was taken at this time point.', 'groupId': 'OG000'}, {'value': '205.57', 'spread': '239.508', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 hours', 'description': 'Analyze the urine concentration of hydromorphone', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': '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'}, {'id': 'FG001', 'title': 'Group 2', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': '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'}, {'id': 'BG001', 'title': 'Group 2', 'description': '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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.63', 'spread': '8.937', 'groupId': 'BG000'}, {'value': '54.28', 'spread': '8.279', 'groupId': 'BG001'}, {'value': '48.60', 'spread': '10.062', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2012-01-04', 'resultsFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-17', 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration of Hydromorphone', 'timeFrame': 'Up to 6 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Correlation of Plasma PK of Hydrocodone', 'timeFrame': '1 Month', 'description': 'Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.'}, {'measure': 'Peak Urine Concentration of Hydromorphone', 'timeFrame': 'Up to 4 hours', 'description': 'Analyze the urine concentration of hydromorphone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Hydromorphone', 'Hydrocodone', 'APAP'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '11499035', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11936695', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1016/s1570-0232(01)00616-x.'}, {'pmid': '12535841', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1016/s1570-0232(02)00856-5.'}, {'pmid': '14998425', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1046/j.1365-2125.2003.02002.x.'}, {'pmid': '37301', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1111/j.2042-7158.1979.tb13507.x.'}, {'pmid': '7693389', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1038/clpt.1993.177.'}]}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman aged 18-75\n* Documented clinical diagnosis of chronic pain.\n* Have been taking hydrocodone/APAP for their chronic non-cancer pain.\n* Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.\n* Subjects 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\n* Subjects 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.\n* Health concerns that the study physician feels may confound study results.\n* Individuals who are cognitively impaired or who are not able to give informed consent.\n* Previous participation in a clinical research trial within 30 days prior to randomization.\n* The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.'}, 'identificationModule': {'nctId': 'NCT01517295', 'briefTitle': 'Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NEMA Research, Inc.'}, 'officialTitle': 'Evaluating the Pharmacokinetic Profile of Hydromorphone in Chronic Pain Patients Taking Hydrocodone/APAP', 'orgStudyIdInfo': {'id': 'NEMA-HydrocodonePK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '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.', 'interventionNames': ['Drug: Hydrocodone']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '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.', 'interventionNames': ['Drug: Hydrocodone']}], 'interventions': [{'name': 'Hydrocodone', 'type': 'DRUG', 'otherNames': ['Hydrocodone/APAP', 'Vicodin'], 'description': 'Dose: Standard prescribed dose Frequency: Once Duration: Once', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34108', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'NEMA Research Inc. (CRO)', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '66211', 'city': 'Leawood', 'state': 'Kansas', 'country': 'United States', 'facility': 'International Clinical Research Institute', 'geoPoint': {'lat': 38.96667, 'lon': -94.6169}}], 'overallOfficials': [{'name': 'Srinivas Nalamachu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Clinical Research Institute'}, {'name': 'Joseph Pergolizzi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NEMA Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NEMA Research, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, {'name': 'International Clinical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}