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Ignite Creation Date: 2025-12-24 @ 3:37 PM

Ignite Modification Date: 2026-02-24 @ 2:09 PM

Study NCT ID: NCT00420992

Status: COMPLETED

Last Update Posted: 2013-09-20

First Post: 2007-01-10

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C550436', 'term': 'morphine, naltrexone combination'}, {'id': 'D009020', 'term': 'Morphine'}], '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': {'phone': '919-653-7001', 'title': 'Vice President, Clinical Development', 'organization': 'King Pharmaceuticals Research and Development, Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the Sponsor for review. Sponsor may request a delay in publication to allow the filing of patent applications before publication or release. The sponsor can require deletion of Confidential Information or request correction of inaccuracies.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ALO-01', 'otherNumAtRisk': 171, 'otherNumAffected': 54, 'seriousNumAtRisk': 171, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 173, 'otherNumAffected': 48, 'seriousNumAtRisk': 173, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Titration ALO-01', 'description': 'Open-label ALO-01', 'otherNumAtRisk': 547, 'otherNumAffected': 301, 'seriousNumAtRisk': 547, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 167}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 115}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 78}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 38}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 547, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALO-01'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0445', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.', 'groupDescription': 'Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included treatment as factor and baseline pain score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'randomization to 12 weeks following randomization', 'description': 'Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ALO-01'}, {'id': 'FG001', 'title': 'Placebo'}], 'periods': [{'title': 'Titration Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All patients received ALO-01 during open-label titration phase', 'groupId': 'FG000', 'numSubjects': '547'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '75'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ALO-01'}, {'id': 'BG001', 'title': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '11.62', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '12.92', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '12.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 547}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'dispFirstSubmitDate': '2009-03-09', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-13', 'studyFirstSubmitDate': '2007-01-10', 'dispFirstSubmitQcDate': '2009-10-28', 'resultsFirstSubmitDate': '2009-09-11', 'studyFirstSubmitQcDate': '2007-01-10', 'dispFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-28', 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)', 'timeFrame': 'randomization to 12 weeks following randomization', 'description': 'Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.'}]}, 'conditionsModule': {'keywords': ['hip', 'knee', 'pain', 'osteoarthritis', 'OA', 'Kadian', 'Alpharma', 'naltrexone', 'Opioid', 'morphine', 'Embeda', 'ALO-01'], 'conditions': ['Osteoarthritis', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '26695349', 'type': 'DERIVED', 'citation': 'Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.', 'detailedDescription': 'The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 21 years of age or older\n* Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential\n* Negative pregnancy test if female of childbearing potential\n* Subject is in general good health\n* Subject required treatment of joint pain within the last 90 days\n* Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee\n\nExclusion Criteria:\n\n* Subject has a documented history of allergic reaction or intolerance to morphine or other opioids\n* Subject is pregnant or breast-feeding\n* Subject is receiving systemic chemotherapy\n* Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence\n* Subject has history of major depressive disorder not controlled with medication\n* Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA\n* Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)\n* Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis'}, 'identificationModule': {'nctId': 'NCT00420992', 'briefTitle': 'A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee', 'orgStudyIdInfo': {'id': 'ALO-KNT-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALO-01', 'description': 'Up to 80 mg twice a day (bid)', 'interventionNames': ['Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Twice a day (bid)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)', 'type': 'DRUG', 'otherNames': ['Embeda'], 'description': 'capsules, up to 80 mg bid', 'armGroupLabels': ['ALO-01']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'capsules, bid', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Birmingham Pain Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Horizon Research Group', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85383', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Center for Clinical Research', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center, Inc', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Premiere Pharmaceutical Research, LLC', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'STAT-CARE / Crest Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'Southbay Pharma Research', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Res. (C-trials)', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '95628', 'city': 'Fair Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Med Investigators Inc', 'geoPoint': {'lat': 38.64463, 'lon': -121.27217}}, {'zip': '90716', 'city': 'Hawaiian Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Quality of Life Medical Center, LLC', 'geoPoint': {'lat': 33.8314, 'lon': -118.07284}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'NervePro Research', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Pain and Palliative Care', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'USCD Pain and Palliative Care', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90660', 'city': 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