Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 6:35 AM
Study NCT ID:
NCT00761150
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2008-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006853', 'term': 'Hydrocodone'}], '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': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were recorded from the time of study drug administration to 30 days after last dose (total 12 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 16 weeks).', 'description': 'AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (ABT-712 or placebo) in the DB period.', 'eventGroups': [{'id': 'EG000', 'title': 'Open-label ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).', 'otherNumAtRisk': 308, 'otherNumAffected': 169, 'seriousNumAtRisk': 308, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Double-blind ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).', 'otherNumAtRisk': 120, 'otherNumAffected': 18, 'seriousNumAtRisk': 120, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Double-blind Placebo', 'description': '2 placebo tablets, twice daily, for 4 weeks (double-blind period).', 'otherNumAtRisk': 118, 'otherNumAffected': 19, 'seriousNumAtRisk': 118, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}], 'seriousEvents': [{'term': 'DIVERTICULAR PERFORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': '2 placebo tablets, twice daily, for 4 weeks (double-blind period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '2.43', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Double-blind baseline to 4 weeks', 'description': 'The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': '2 placebo tablets, twice daily, for 4 weeks (double-blind period).'}], 'classes': [{'title': 'Trouble Falling Asleep', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': 'Needed Sleeping Medication', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '2.09', 'groupId': 'OG001'}]}]}, {'title': 'Awakened by Pain During the Night', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'Awakened by Pain in the Morning', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Sleep', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-13.9', 'spread': '2.66', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Double-blind baseline to 4 weeks', 'description': "The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-label ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).'}, {'id': 'FG001', 'title': 'Double-blind ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).'}, {'id': 'FG002', 'title': 'Double-blind Placebo', 'description': '2 placebo tablets, twice daily, for 4 weeks (double-blind period).'}], 'periods': [{'title': 'Open-label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '308'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not meet DB randomization criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Did not meet DB randomization criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '308', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Nonrandomized', 'description': '2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.'}, {'id': 'BG001', 'title': 'Double-blind ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).'}, {'id': 'BG002', 'title': 'Double-blind Placebo', 'description': '2 placebo tablets, twice daily, for 4 weeks (double-blind period).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '12.31', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '12.64', 'groupId': 'BG001'}, {'value': '48.4', 'spread': '12.24', 'groupId': 'BG002'}, {'value': '49.0', 'spread': '12.44', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Double-blind Baseline CLBP Intensity VAS', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'These subjects were not randomized to the double-blind period.', 'groupId': 'BG000'}, {'value': '22.4', 'spread': '15.25', 'groupId': 'BG001'}, {'value': '22.9', 'spread': '14.86', 'groupId': 'BG002'}, {'value': '22.6', 'spread': '15.03', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The last assessment using the CLBP Intensity Visual Analog Scale (VAS) (0 mm = No Pain and 100 mm = Worst Pain Imaginable) conducted before the first dose in the double-blind period.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Double-blind Baseline Sleep Interference by Pain Scale', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'These subjects were not randomized to the double-blind period.', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '2.01', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.82', 'groupId': 'BG002'}, {'value': '2.2', 'spread': '1.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The last assessment of how much back pain interfered with their sleep on a scale of 0 (not at all) to 10 (completely) conducted before the first dose in the double-blind period.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'dispFirstSubmitDate': '2012-10-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2008-09-25', 'dispFirstSubmitQcDate': '2012-10-08', 'resultsFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2008-09-26', 'dispFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-01', 'studyFirstPostDateStruct': {'date': '2008-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)', 'timeFrame': 'Double-blind baseline to 4 weeks', 'description': 'The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.'}], 'secondaryOutcomes': [{'measure': 'Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)', 'timeFrame': 'Double-blind baseline to 4 weeks', 'description': "The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Effect on sleep interference by pain'], 'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).', 'detailedDescription': 'The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female subjects who voluntarily sign the informed consent\n* Diagnosis of CLBP of 6 months duration\n\nExclusion Criteria:\n\n* Incapacitated or bedridden subjects\n* Subjects with history of surgical or invasive intervention'}, 'identificationModule': {'nctId': 'NCT00761150', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3, Open-Label Period Followed by a Randomized, Double-blind, Placebo-controlled Study of the Analgesic Efficacy of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'M10-385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).', 'interventionNames': ['Drug: ABT-712']}, {'type': 'EXPERIMENTAL', 'label': 'Double-blind ABT-712', 'description': '2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).', 'interventionNames': ['Drug: ABT-712']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-blind Placebo', 'description': '2 placebo tablets, twice daily, for 4 weeks (double-blind period).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ABT-712', 'type': 'DRUG', 'otherNames': ['Hydrocodone and acetaminophen extended-release', 'Hydrocodone bitartrate and acetaminophen extended-release'], 'description': 'ABT-712 extended-release tablet', 'armGroupLabels': ['Double-blind ABT-712', 'Open-label ABT-712']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['Double-blind Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 10143', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 10161', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 10155', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 10160', 'geoPoint': {'lat': 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