Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT03528369
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': 'D002211', 'term': 'Capsaicin'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'twarneke@vizuriusa.com', 'phone': '919-397-4782', 'title': 'Vice President Clinical Operations', 'organization': 'Vizuri Health Sciences'}, 'certainAgreement': {'otherDetails': "Sponsor can review results and communications prior to public release, and Sponsor can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the Sponsor for review. At all times, PIs retain editorial control of all publications and have a right to publish the study data, subject only to Sponsor's time-limited right to protect its intellectual property rights and prevent disclosure of Sponsor's confidential information.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were captured from start of study drug treatment through Day 94', 'description': 'Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0', 'eventGroups': [{'id': 'EG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 41, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 24, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Application site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-130.7', 'groupId': 'OG000', 'lowerLimit': '-354', 'upperLimit': '54'}, {'value': '-159.7', 'groupId': 'OG001', 'lowerLimit': '-376', 'upperLimit': '34'}, {'value': '-99.0', 'groupId': 'OG002', 'lowerLimit': '-328', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35 days after the last dose of study drug on Day 4', 'description': 'The Primary Efficacy endpoint of this study will be to examine the extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of Vehicle (CGS-200-0), CGS-200-1 and CGS-200-5 at Baseline (\\< 30 minutes prior to first daily application) and Day 35 (31 days after fourth daily application).\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Reduction in pain is expressed as a difference from baseline to Study Day 35. Positive numbers indicate increases and negative numbers indicate decreases. .', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy Endpoint #1: Extent of Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 5, 19, 64 and 94.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'title': 'Day 5 WOMAC Pain Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-113.1', 'groupId': 'OG000', 'lowerLimit': '-359', 'upperLimit': '42'}, {'value': '-157.5', 'groupId': 'OG001', 'lowerLimit': '-367', 'upperLimit': '40'}, {'value': '-64.5', 'groupId': 'OG002', 'lowerLimit': '-409', 'upperLimit': '57'}]}]}, {'title': 'Day 19 WOMAC Pain Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-131.8', 'groupId': 'OG000', 'lowerLimit': '-338', 'upperLimit': '75'}, {'value': '-171.7', 'groupId': 'OG001', 'lowerLimit': '-388', 'upperLimit': '21'}, {'value': '-66.4', 'groupId': 'OG002', 'lowerLimit': '-289', 'upperLimit': '72'}]}]}, {'title': 'Day 64 WOMAC Pain Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-79.5', 'groupId': 'OG000', 'lowerLimit': '-345', 'upperLimit': '132'}, {'value': '-169.8', 'groupId': 'OG001', 'lowerLimit': '-358', 'upperLimit': '34'}, {'value': '75.4', 'groupId': 'OG002', 'lowerLimit': '-291', 'upperLimit': '107'}]}]}, {'title': 'Day 94 WOMAC Pain Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-111.8', 'groupId': 'OG000', 'lowerLimit': '-349', 'upperLimit': '72'}, {'value': '-147.6', 'groupId': 'OG001', 'lowerLimit': '-378', 'upperLimit': '98'}, {'value': '-80.1', 'groupId': 'OG002', 'lowerLimit': '-332', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 5, 19, 65 and 94 after the last dose of study drug on Day 4', 'description': 'The extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of CGS-200-0, CGS-200-1 and CGS-200-5 from Baseline to Day 5, 19, 64 and Day 94.\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Positive numbers indicate increases and negative numbers indicate decreases.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug. Differences in subjects is due to subjects who withdrew from the study prior to the efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'title': 'Mean Burning-Stinging Pain on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7.75'}, {'value': '2.70', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.25'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3.25'}]}]}, {'title': 'Mean Burning-Stinging Pain on Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3.75'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.75'}, {'value': '0.49', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5.75'}]}]}, {'title': 'Mean Burning-Stinging Pain Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3.50'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.25'}, {'value': '0.22', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2.50'}]}]}, {'title': 'Mean Burning-Stinging Pain Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.50'}, {'value': '1.47', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.00'}, {'value': '0.20', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes after study drug application on Study Days 1,2,3,4', 'description': 'The average amount of burning-sting pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who have received at least one dose of study drug. The number of subjects analyzed differs in some cases due to missing data.'}, {'type': 'SECONDARY', 'title': 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'title': 'Day 5 WOMAC Stiffness Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-50.7', 'groupId': 'OG000', 'lowerLimit': '-147', 'upperLimit': '58'}, {'value': '-59.6', 'groupId': 'OG001', 'lowerLimit': '-166', 'upperLimit': '32'}, {'value': '-25.6', 'groupId': 'OG002', 'lowerLimit': '-188', 'upperLimit': '39'}]}]}, {'title': 'Day 19 WOMAC Stiffness Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-52.2', 'groupId': 'OG000', 'lowerLimit': '-152', 'upperLimit': '109'}, {'value': '-65.5', 'groupId': 'OG001', 'lowerLimit': '-161', 'upperLimit': '65'}, {'value': '-26.8', 'groupId': 'OG002', 'lowerLimit': '-152', 'upperLimit': '29'}]}]}, {'title': 'Day 35 WOMAC Stiffness Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-46.0', 'groupId': 'OG000', 'lowerLimit': '-154', 'upperLimit': '78'}, {'value': '-54.8', 'groupId': 'OG001', 'lowerLimit': '-137', 'upperLimit': '33'}, {'value': '-39.8', 'groupId': 'OG002', 'lowerLimit': '-158', 'upperLimit': '30'}]}]}, {'title': 'Day 64 WOMAC Stiffness Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-32.2', 'groupId': 'OG000', 'lowerLimit': '-150', 'upperLimit': '114'}, {'value': '-59.5', 'groupId': 'OG001', 'lowerLimit': '-162', 'upperLimit': '29'}, {'value': '-28.1', 'groupId': 'OG002', 'lowerLimit': '-158', 'upperLimit': '42'}]}]}, {'title': 'Day 94 WOMAC Stiffness Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-42.7', 'groupId': 'OG000', 'lowerLimit': '-151', 'upperLimit': '37'}, {'value': '-56.8', 'groupId': 'OG001', 'lowerLimit': '-166', 'upperLimit': '45'}, {'value': '-31.9', 'groupId': 'OG002', 'lowerLimit': '-159', 'upperLimit': '42'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4', 'description': 'Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 2 questions relating to stiffness that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 200. Positive numbers indicate increases and negative numbers indicate decreases.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint. Differences in number of subjects is due to subjects early withdrawal from the study.'}, {'type': 'SECONDARY', 'title': 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'title': 'Day 5 WOMAC Function Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-385.0', 'groupId': 'OG000', 'lowerLimit': '-1174', 'upperLimit': '346'}, {'value': '-499.0', 'groupId': 'OG001', 'lowerLimit': '-1397', 'upperLimit': '59'}, {'value': '-198.1', 'groupId': 'OG002', 'lowerLimit': '-1343', 'upperLimit': '223'}]}]}, {'title': 'Day 19 WOMAC Function Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-398.7', 'groupId': 'OG000', 'lowerLimit': '-1275', 'upperLimit': '501'}, {'value': '-583.7', 'groupId': 'OG001', 'lowerLimit': '-1415', 'upperLimit': '100'}, {'value': '-192.1', 'groupId': 'OG002', 'lowerLimit': '-1219', 'upperLimit': '315'}]}]}, {'title': 'Day 35 WOMAC Function Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-367.8', 'groupId': 'OG000', 'lowerLimit': '-1240', 'upperLimit': '456'}, {'value': '-523.0', 'groupId': 'OG001', 'lowerLimit': '-1397', 'upperLimit': '286'}, {'value': '-296.9', 'groupId': 'OG002', 'lowerLimit': '-1278', 'upperLimit': '279'}]}]}, {'title': 'Day 64 WOMAC Function Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-218.9', 'groupId': 'OG000', 'lowerLimit': '-1286', 'upperLimit': '796'}, {'value': '-515.9', 'groupId': 'OG001', 'lowerLimit': '-1261', 'upperLimit': '299'}, {'value': '-213.7', 'groupId': 'OG002', 'lowerLimit': '-901', 'upperLimit': '357'}]}]}, {'title': 'Day 94 WOMAC Function Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-337.5', 'groupId': 'OG000', 'lowerLimit': '-1273', 'upperLimit': '249'}, {'value': '-506.5', 'groupId': 'OG001', 'lowerLimit': '-1406', 'upperLimit': '191'}, {'value': '-233', 'groupId': 'OG002', 'lowerLimit': '-1297', 'upperLimit': '349'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4', 'description': 'Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function score is 17 questions relating to physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 1700. Positive numbers indicate increases and negative numbers indicate decreases.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint. Differences in number of subjects is due to subjects early withdrawal from the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects With Skin Reactions of Erythema or Pruritus.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'title': 'Erythema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study Day 1 through Study Day 35 after the first application of study drug (Study Day 1)', 'description': 'Investigator reports of erythema or pruritus at the site of study drug application.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who have received at least one dose of study drug'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects With Durability of Efficacy Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'title': 'Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Responders', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'Non-Responders', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Day 64 Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Responders', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Non-Responders', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Day 94 Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Responders', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}, {'title': 'Non-Responders', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 35, 64 and 94 day after the last dose of study drug on Study Day 4', 'description': 'Subjects who had a clinical response (i.e., reduction of at least 50% in WOMAC pain score) at the Day 5 visit and who remained at this reduction of pain score or lower at Days 19, 35, 64, and the Day 94 visit were considered to have a durable clinical response through Day 94. Subjects who had a clinical response at no more than one of the post Day 5 visits were considered to have a durable response through the last day at which reduction in WOMAC pain score is at least 50%. Subjects who had less than 50% WOMAC pain score reduction on two or more of the post Day 5 visits were considered to have failed to achieve a durable clinical response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint.'}, {'type': 'POST_HOC', 'title': 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Total Scores (Pain, Stiffness and Function).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'OG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'OG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'classes': [{'title': 'Day 5 WOMAC Total Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-548.8', 'groupId': 'OG000', 'lowerLimit': '-1747', 'upperLimit': '572'}, {'value': '-716.1', 'groupId': 'OG001', 'lowerLimit': '-1928', 'upperLimit': '22'}, {'value': '-288.1', 'groupId': 'OG002', 'lowerLimit': '-1940', 'upperLimit': '285'}]}]}, {'title': 'Day 19 WOMAC Total Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-582.8', 'groupId': 'OG000', 'lowerLimit': '-1747', 'upperLimit': '572'}, {'value': '-820.9', 'groupId': 'OG001', 'lowerLimit': '-1961', 'upperLimit': '121'}, {'value': '-285.3', 'groupId': 'OG002', 'lowerLimit': '-1660', 'upperLimit': '406'}]}]}, {'title': 'Day 35 WOMAC Total Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-544.5', 'groupId': 'OG000', 'lowerLimit': '-1748', 'upperLimit': '366'}, {'value': '-737.5', 'groupId': 'OG001', 'lowerLimit': '-1899', 'upperLimit': '353'}, {'value': '-435.8', 'groupId': 'OG002', 'lowerLimit': '-1747', 'upperLimit': '370'}]}]}, {'title': 'Day 64 WOMAC Total Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-330.6', 'groupId': 'OG000', 'lowerLimit': '-1781', 'upperLimit': '901'}, {'value': '-745.2', 'groupId': 'OG001', 'lowerLimit': '-1759', 'upperLimit': '337'}, {'value': '-317.2', 'groupId': 'OG002', 'lowerLimit': '-1261', 'upperLimit': '506'}]}]}, {'title': 'Day 94 WOMAC Total Score Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-491.9', 'groupId': 'OG000', 'lowerLimit': '-1769', 'upperLimit': '331'}, {'value': '-710.8', 'groupId': 'OG001', 'lowerLimit': '-1939', 'upperLimit': '314'}, {'value': '-345.9', 'groupId': 'OG002', 'lowerLimit': '-1769', 'upperLimit': '331'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4', 'description': 'Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index total scores (pain, stiffness and function) from Baseline.\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 24 questions relating to pain, stiffness and physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 2400. Positive numbers indicate increases and negative numbers indicate decreases.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint. Differences in number of subjects is due to subjects early withdrawal from the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'FG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'FG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited at 6 investigative sites in the US.', 'preAssignmentDetails': 'Subjects were randomized to receive one of three treatments after the investigator deemed them to qualify for the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.'}, {'id': 'BG001', 'title': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.'}, {'id': 'BG002', 'title': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.\n\nCGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '75'}, {'value': '61.1', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '74'}, {'value': '59.5', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '72'}, {'value': '60', 'groupId': 'BG003', 'lowerLimit': '40', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '102', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score', 'classes': [{'categories': [{'measurements': [{'value': '357.0', 'groupId': 'BG000', 'lowerLimit': '260', 'upperLimit': '486'}, {'value': '350.7', 'groupId': 'BG001', 'lowerLimit': '266', 'upperLimit': '460'}, {'value': '346.8', 'groupId': 'BG002', 'lowerLimit': '254', 'upperLimit': '490'}, {'value': '351.5', 'groupId': 'BG003', 'lowerLimit': '254', 'upperLimit': '490'}]}]}], 'paramType': 'MEAN', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. The higher the number the worse the outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-01', 'size': 1945340, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-02T15:55', 'hasProtocol': True}, {'date': '2019-01-24', 'size': 1631592, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-26T14:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-19', 'studyFirstSubmitDate': '2018-03-20', 'resultsFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2018-05-06', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-02', 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Subjects With Skin Reactions of Erythema or Pruritus.', 'timeFrame': 'Study Day 1 through Study Day 35 after the first application of study drug (Study Day 1)', 'description': 'Investigator reports of erythema or pruritus at the site of study drug application.'}, {'measure': 'Number of Subjects With Durability of Efficacy Response', 'timeFrame': 'Days 35, 64 and 94 day after the last dose of study drug on Study Day 4', 'description': 'Subjects who had a clinical response (i.e., reduction of at least 50% in WOMAC pain score) at the Day 5 visit and who remained at this reduction of pain score or lower at Days 19, 35, 64, and the Day 94 visit were considered to have a durable clinical response through Day 94. Subjects who had a clinical response at no more than one of the post Day 5 visits were considered to have a durable response through the last day at which reduction in WOMAC pain score is at least 50%. Subjects who had less than 50% WOMAC pain score reduction on two or more of the post Day 5 visits were considered to have failed to achieve a durable clinical response.'}], 'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35', 'timeFrame': '35 days after the last dose of study drug on Day 4', 'description': 'The Primary Efficacy endpoint of this study will be to examine the extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of Vehicle (CGS-200-0), CGS-200-1 and CGS-200-5 at Baseline (\\< 30 minutes prior to first daily application) and Day 35 (31 days after fourth daily application).\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Reduction in pain is expressed as a difference from baseline to Study Day 35. Positive numbers indicate increases and negative numbers indicate decreases. .'}], 'secondaryOutcomes': [{'measure': 'Secondary Efficacy Endpoint #1: Extent of Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 5, 19, 64 and 94.', 'timeFrame': 'Days 5, 19, 65 and 94 after the last dose of study drug on Day 4', 'description': 'The extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of CGS-200-0, CGS-200-1 and CGS-200-5 from Baseline to Day 5, 19, 64 and Day 94.\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Positive numbers indicate increases and negative numbers indicate decreases.'}, {'measure': 'Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug.', 'timeFrame': '60 minutes after study drug application on Study Days 1,2,3,4', 'description': 'The average amount of burning-sting pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.', 'timeFrame': 'Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4', 'description': 'Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 2 questions relating to stiffness that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 200. Positive numbers indicate increases and negative numbers indicate decreases.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.', 'timeFrame': 'Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4', 'description': 'Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.\n\nThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function score is 17 questions relating to physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 1700. Positive numbers indicate increases and negative numbers indicate decreases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee', 'Pain']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blind clinical trial to examine the comparative effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content) (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied at the clinic for 60 minutes on each of four consecutive days.', 'detailedDescription': 'Subjects will be randomized to one of the three Arms in this study: CGS-200-1 or CGS-200-5 or CGS-200 Vehicle (CGS-200-0). All subjects will receive 4 consecutive days of treatment and will then be followed up until the Day 94 visit.\n\nEven though both knee(s) will receive application of study test materials, with regard to reduction in WOMAC pain and VAS pain score associated with study treatments, only one knee will be indicated as the "Study Knee". This will be the knee with the highest WOMAC pain score at screening. If both knees have equal WOMAC pain scores at baseline, then the right knee will be considered the "Study Knee" with regard to WOMAC pain and VAS pain score reduction.\n\nData will be collected from Day 1 through Day 5 and then again on Days 19, 35, 64 and 94 for efficacy, tolerability, and safety measures. The Investigators, all site staff and Clinical Research Organization (CRO) personnel (except the Medical Monitor providing safety oversight) directly involved in the study will remain blinded to the treatment assignment throughout the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Osteoarthritis (OA) of both knees;\n* OA of both knees must be confirmed by tibiofemoral joint radiographs obtained within the past 6 months;\n* Rheumatoid factor (RF) negative and Erythrocyte sedimentation rate (ESR) \\<40 mm/hr;\n* Chronic knee pain in at least 1 knee for \\> 3 months;\n* WOMAC pain score of \\> 250 (using VAS WOMAC format) at screening, and at baseline, in at least one knee;\n* Knee pain score of \\> 5 on the NRS pain scale at screening, and at baseline, in at least one knee;\n* Knee pain is not potentially due to acute trauma unrelated to OA (no acute traumatic knee injury in medical history);\n* No burning-stinging pain, unrelated to subject's knee pain, at intended site of application;\n* Knee pain must be greater than pain in any other part of subject's body;\n* American College of Rheumatology (ACR) global functional status I, II, or III (excluding IV).\n\nExclusion Criteria:\n\n* Spontaneously improving or rapidly deteriorating OA of the knee;\n* Rheumatoid or psoriatic arthritis, or a form of arthritis (e.g. gout, pseudogout), Paget's disease of bone, or any other disease affecting the joints that are inconsistent with a diagnosis of idiopathic OA;\n* Labile or poorly controlled hypertension;\n* Use of steroids for 1 month prior to screening, or intraarticular-visco-supplementation within 3 months prior to screening;\n* Used any capsaicin-containing product on or in the vicinity of the knee within 4 weeks prior to screening;\n* Used topically applied products (including emollients or moisturizers) on or in the vicinity of the knees or shaved the knees within 2 days prior to the first application of study drug; or an open wound near the knee; cutaneous erythema or edema; any inflammatory skin lesions such as eczema or psoriasis; cutaneous infections; or any other compromise of the skin;\n* Requires or anticipates any surgical procedure within 3 months prior to screening, has had surgery on the affected joint within 6 months prior to screening, has a prosthesis in either knee, or would require surgery while participating in the trial."}, 'identificationModule': {'nctId': 'NCT03528369', 'briefTitle': 'A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 2 Double-Blind Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% Capsaicin Topical Liquid), CGS-200-5 (5% Capsaicin Topical Liquid), and CGS-200-0 (Vehicle, No Capsaicin)', 'orgStudyIdInfo': {'id': 'VZU00025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGS-200-1', 'description': 'CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.', 'interventionNames': ['Drug: CGS-200-1']}, {'type': 'EXPERIMENTAL', 'label': 'CGS-200-5', 'description': 'CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.', 'interventionNames': ['Drug: CGS-200-5']}, {'type': 'SHAM_COMPARATOR', 'label': 'CGS-200 Vehicle', 'description': 'CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.', 'interventionNames': ['Drug: CGS-200 Vehicle']}], 'interventions': [{'name': 'CGS-200-1', 'type': 'DRUG', 'otherNames': ['CGS-200 (1% capsaicin)'], 'description': 'CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.', 'armGroupLabels': ['CGS-200-1']}, {'name': 'CGS-200-5', 'type': 'DRUG', 'otherNames': ['CGS-200 (5% capsaicin)'], 'description': 'CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.', 'armGroupLabels': ['CGS-200-5']}, {'name': 'CGS-200 Vehicle', 'type': 'DRUG', 'otherNames': ['CGS-200 (0% capsaicin)'], 'description': 'CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.', 'armGroupLabels': ['CGS-200 Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'McIlwain Medical Group', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI Clinical Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Vice President Clinical Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vizuri Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Propella Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}