Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT03277066
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2017-09-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gklauss@noven.com', 'phone': '1-551-233-2656', 'title': 'Gunnar Klauss, MD', 'organization': 'Noven Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Diclofenac Sodium Active Topical Patch 1', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 9, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diclofenac Sodium Active Topical Patch 2', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 8, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo Patch', 'description': 'Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 19, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Product taste abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Sodium Active Topical Patch 1', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG001', 'title': 'Diclofenac Sodium Active Topical Patch 2', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG002', 'title': 'Placebo Patch', 'description': 'Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '4.06', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '4.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0110', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Lest-Squared Mean Differences', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0110', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2835', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Lest-Squared Mean Differences', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2835', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC Pain Score Week 2 Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Sodium Active Topical Patch 1', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG001', 'title': 'Diclofenac Sodium Active Topical Patch 2', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG002', 'title': 'Placebo Patch', 'description': 'Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '4.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 2. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC Stiffness Score Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Sodium Active Topical Patch 1', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG001', 'title': 'Diclofenac Sodium Active Topical Patch 2', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG002', 'title': 'Placebo Patch', 'description': 'Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score from baseline to week 4. The WOMAC Stiffness scale assesses 2 items including morning stiffness and stiffness occurring later in the day. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of two items range from 0 to 8 with a low score considered as a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Sodium Active Topical Patch 1', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG001', 'title': 'Diclofenac Sodium Active Topical Patch 2', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'OG002', 'title': 'Placebo Patch', 'description': 'Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.8', 'spread': '14.85', 'groupId': 'OG000'}, {'value': '-19.3', 'spread': '13.63', 'groupId': 'OG001'}, {'value': '-15.6', 'spread': '13.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score from baseline to week 4. The WOMAC Physical Function assesses the following 17 items using the 0 to 4 scale. These 17 items include: 1. descending stairs; 2. ascending stairs; 3. rising from sitting; 4. standing; 5. bending to floor; 6. walking on a flat surface; 7. getting in/getting out of car; 8. going shopping; 9. putting on socks; 10. lying in bed; 11. taking off socks; 12. rising from bed; 13. getting in/out of bath; 14. sitting; 15. getting on/off toilet; 16. heavy domestic duties; 17. light domestic duties. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. Total score range from 0 to 68 with lower score considered a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diclofenac Sodium Active Topical Patch 1', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'FG001', 'title': 'Diclofenac Sodium Active Topical Patch 2', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'FG002', 'title': 'Placebo Patch', 'description': 'Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'comment': 'These numbers are the Full Analysis Set population include all randomized subjects who have had at least 1 patch of double-blind study drug applied and who have at least 1 post-baseline assessment of the primary efficacy measure.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'HP-5000-75α Patch (5% Diclofenac Sodium)', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s for 4-week treatment.'}, {'id': 'BG001', 'title': 'HP-5000-DRS400 Patch (5% Diclofenac Sodium)', 'description': 'Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.\n\nDiclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'BG002', 'title': 'Placebo Patch', 'description': 'Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '8.66', 'groupId': 'BG000'}, {'value': '57.1', 'spread': '8.65', 'groupId': 'BG001'}, {'value': '59', 'spread': '8.46', 'groupId': 'BG002'}, {'value': '57.8', 'spread': '8.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.51', 'spread': '5.103', 'groupId': 'BG000'}, {'value': '29.83', 'spread': '4.898', 'groupId': 'BG001'}, {'value': '29.89', 'spread': '5.257', 'groupId': 'BG002'}, {'value': '29.78', 'spread': '5.116', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-31', 'size': 6927993, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-30T14:51', 'hasProtocol': True}, {'date': '2019-10-21', 'size': 2063066, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-30T14:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2017-09-06', 'resultsFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-23', 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score', 'timeFrame': 'Baseline and 4 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'WOMAC Pain Score Week 2 Change From Baseline', 'timeFrame': 'Baseline and 2 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 2. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.'}, {'measure': 'WOMAC Stiffness Score Change From Baseline', 'timeFrame': 'Baseline and 4 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score from baseline to week 4. The WOMAC Stiffness scale assesses 2 items including morning stiffness and stiffness occurring later in the day. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of two items range from 0 to 8 with a low score considered as a better outcome.'}, {'measure': 'WOMAC Physical Function Score', 'timeFrame': 'Baseline and 4 weeks', 'description': 'To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score from baseline to week 4. The WOMAC Physical Function assesses the following 17 items using the 0 to 4 scale. These 17 items include: 1. descending stairs; 2. ascending stairs; 3. rising from sitting; 4. standing; 5. bending to floor; 6. walking on a flat surface; 7. getting in/getting out of car; 8. going shopping; 9. putting on socks; 10. lying in bed; 11. taking off socks; 12. rising from bed; 13. getting in/out of bath; 14. sitting; 15. getting on/off toilet; 16. heavy domestic duties; 17. light domestic duties. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. Total score range from 0 to 68 with lower score considered a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee', 'detailedDescription': 'This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist of up to 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week safety Follow-up Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology (ACR) criteria, including:\n* Symptoms for at least 6 months prior to screening, AND\n* Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND\n* The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed.\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\> 40\n* Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period.\n* Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).'}, 'identificationModule': {'nctId': 'NCT03277066', 'acronym': 'HP-5000', 'briefTitle': 'A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Noven Therapeutics'}, 'officialTitle': 'A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis (OA) of the Knee', 'orgStudyIdInfo': {'id': 'HP-5000-US-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Sodium Active Topical Patch 1', 'description': 'Diclofenac sodium 1 topical patches will be compared against placebo patches.', 'interventionNames': ['Drug: Diclofenac Sodium Active Topical Patch 1', 'Drug: Placebo patch']}, {'type': 'EXPERIMENTAL', 'label': 'Diclofenac Sodium Active Topical Patch 2', 'description': 'Diclofenac sodium 2 topical patches will be compared against placebo patches.', 'interventionNames': ['Drug: Diclofenac Sodium Active Topical Patch 2', 'Drug: Placebo patch']}], 'interventions': [{'name': 'Diclofenac Sodium Active Topical Patch 1', 'type': 'DRUG', 'otherNames': ['HP-5000'], 'description': 'HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s)', 'armGroupLabels': ['Diclofenac Sodium Active Topical Patch 1']}, {'name': 'Diclofenac Sodium Active Topical Patch 2', 'type': 'DRUG', 'otherNames': ['HP-5000'], 'description': 'HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s)', 'armGroupLabels': ['Diclofenac Sodium Active Topical Patch 2']}, {'name': 'Placebo patch', 'type': 'DRUG', 'otherNames': ['Placebo treatment'], 'description': 'Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)', 'armGroupLabels': ['Diclofenac Sodium Active Topical Patch 1', 'Diclofenac Sodium Active Topical Patch 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07310', 'city': 'Jersey City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Noven Pharmaceuticals, Inc.', 'geoPoint': {'lat': 40.72816, 'lon': -74.07764}}], 'overallOfficials': [{'name': 'Gunnar Klauss, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Noven Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noven Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}