Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-31 @ 5:55 AM
Study NCT ID:
NCT00765856
Status:
TERMINATED
Last Update Posted:
2020-12-16
First Post:
2008-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010111', 'term': 'Oxymorphone'}], 'ancestors': [{'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': 'clinicaltrials@endo.com', 'phone': '800-462-3636', 'title': 'Saji Vijayan, MBBS', 'organization': 'Endo Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).', 'eventGroups': [{'id': 'EG000', 'title': 'Titration Period', 'description': 'Open-label dose titration period of up to 4 weeks', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 15, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Maintenance Period', 'description': 'Open-label maintenance period of up to 12 weeks plus 30 days post-last dose', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Sickle cell anemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Acute pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Increased alanine aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Increased aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pouchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Titration Period', 'description': 'Open-label dose titration period of up to 4 weeks'}, {'id': 'OG001', 'title': 'Maintenance Period', 'description': 'Open-label maintenance period of up to 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '35.25', 'spread': '11.955', 'groupId': 'OG000'}, {'value': '39.11', 'spread': '15.176', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as all participants that took at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Titration Period', 'description': 'Open-label dose titration period of up to 4 weeks'}, {'id': 'OG001', 'title': 'Maintenance Period', 'description': 'Open-label maintenance period of up to 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '15.63', 'groupId': 'OG000'}, {'value': '162.7', 'spread': '66.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.', 'unitOfMeasure': 'Tablets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as all participants that took at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Titration Period', 'description': 'Open-label dose titration period of up to 4 weeks. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure'}, {'id': 'OG001', 'title': 'Maintenance Period', 'description': 'Open-label maintenance period of up to 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as all participants that took at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Titration Period', 'description': 'Open-label dose titration period of up to 4 weeks. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure'}, {'id': 'OG001', 'title': 'Maintenance Period', 'description': 'Open-label maintenance period of up to 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.', 'unitOfMeasure': 'Rescue doses/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as all participants that took at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Titration Period', 'description': 'Open-label dose titration period of up to 4 weeks. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure'}, {'id': 'OG001', 'title': 'Maintenance Period', 'description': 'Open-label maintenance period of up to 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '15.36', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '40.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.', 'unitOfMeasure': 'Total number of doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as all participants that took at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxymorphone ER', 'description': 'Oxymorphone ER dosage was adjusted by investigator during the titration period. Study was terminated early by the Sponsor.'}], 'periods': [{'title': 'Titration Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}, {'title': 'Maintenance Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxymorphone ER', 'description': 'Open-label dose titration period of up to 4 weeks and open-label maintenance period of up to 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '1.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Terminated new protocol developed which incorporated Pharmacokinetics', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2010-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2008-10-02', 'resultsFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-20', 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.'}], 'secondaryOutcomes': [{'measure': 'Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.'}, {'measure': 'Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.'}, {'measure': 'Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.'}, {'measure': 'Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses', 'timeFrame': 'Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)', 'description': 'Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid tolerant', 'Pediatric', 'Male 6-17 years of age', 'Female 6-17 years of age', 'Pain', 'Non malignant', 'Malignant'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject\'s pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.', 'detailedDescription': 'An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)\n* Weigh at least 50 kg\n* Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.\n\nExclusion Criteria:\n\n* Have a life expectancy \\<4 weeks\n* Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period\n* Have dysphagia or difficulty swallowing whole tablets\n* Have a previous exposure to oxymorphone\n* Have an ileostomy'}, 'identificationModule': {'nctId': 'NCT00765856', 'briefTitle': 'Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': 'An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.', 'orgStudyIdInfo': {'id': 'EN3202 036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxymorphone ER', 'interventionNames': ['Drug: Oxymorphone ER']}], 'interventions': [{'name': 'Oxymorphone ER', 'type': 'DRUG', 'otherNames': ['Opana ER, Opana'], 'description': 'Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.\n\nOxymorphone IR (Opana) IR 5mg tablet - used as rescue medications', 'armGroupLabels': ['Oxymorphone ER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32257', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Institute of Medical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34104', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Tukoi Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33618', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Children's Hospital of Tampa", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Taylor Research, LLC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Rehabilitation Associates of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Reserach Foundation, Inc.', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '17112', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Sr. Director CR&D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}