Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-02-06 @ 5:01 AM
Study NCT ID:
NCT00528606
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2007-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003012', 'term': 'Microbial Collagenase'}], 'ancestors': [{'id': 'D017364', 'term': 'Collagenases'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalsite.inquiries@endo.com', 'title': 'Clinical Trial Coordinator', 'organization': 'Endo Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'Auxilium Pharmaceuticals, Inc. agreements may vary with individual investigators but will not prohibit any investigator from publishing. Auxilium supports the publication of results from all centers of a multicenter trial but requests that reports based on single site data not preceed the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study.', 'description': 'This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \\& XIAFLEX Prescribing Information (see links above).', 'eventGroups': [{'id': 'EG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints', 'otherNumAtRisk': 204, 'otherNumAffected': 196, 'seriousNumAtRisk': 204, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints', 'otherNumAtRisk': 104, 'otherNumAffected': 25, 'seriousNumAtRisk': 104, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 178, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 72, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 142, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 117, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 63, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 296, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 95, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 85, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Acute cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Ligament disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pelvi-ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Spinal fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'p-value based on Cochran-Mantel-Haenszel test comparing treatment groups, stratified by baseline severity group and joint type.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days after the last injection', 'description': 'The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.\n\nThe Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.', 'unitOfMeasure': 'Percentage of Joints', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified-Intent-to-Treat population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement After the Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; within 30 days after the last injection', 'description': 'Clinical Improvement is defined as \\>= 50% reduction from baseline in degree of contracture within 30 days of the injection.', 'unitOfMeasure': 'Percentage of Joints', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population( Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline Contracture After the Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '79.3', 'spread': '32.58', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '30.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; within 30 days after the last injection', 'description': 'Percent change in degree of contracture measured as 100\\* (baseline contracture - last available post-injection contracture)/baseline contracture.', 'unitOfMeasure': 'Percent reduction from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Range of Motion After the Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '36.70', 'spread': '21.01', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '14.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baselin; within 30 days after the last injection', 'description': 'Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)'}, {'type': 'SECONDARY', 'title': 'Time to First Achieve Success After the Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'title': 'Injection 1, Day 1', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 1, Day 7', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 1, Day 30', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 2, Day 0', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 2, Day 1', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 2, Day 7', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 2, Day 30', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 3, Day 0', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 3, Day 1', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 3, Day 7', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection 3, Day 30', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Did not reach clinical success by last injection', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '93.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last evaluation visit on which clinical success is achieved through the Day 30 evaluation', 'unitOfMeasure': 'percentage of joints', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days after first injection', 'description': 'Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.', 'unitOfMeasure': 'Percentage of Joints', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement After the First Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; within 30 days after the first injection', 'description': 'Clinical Improvement is defined as \\>= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.', 'unitOfMeasure': 'Percentage of Joints', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline Contracture After the First Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '34.60', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '20.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, within 30 days after the first injection', 'description': 'Percent change in degree of contracture measured as 100\\* (baseline contracture - last available post-injection contracture)/baseline contracture.', 'unitOfMeasure': 'Percent reduction from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Range of Motion After the First Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'classes': [{'categories': [{'measurements': [{'value': '28.30', 'spread': '20.23', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '11.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; within 30 days after the first injection', 'description': 'Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population (Change in degree of motion measured as last available post-injection range of motion - baseline range of motion)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AA4500 0.58 mg', 'description': 'collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2007-09-11', 'resultsFirstSubmitDate': '2010-09-24', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-09-24', 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection', 'timeFrame': 'Within 30 days after the last injection', 'description': 'The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.\n\nThe Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.'}], 'secondaryOutcomes': [{'measure': 'Clinical Improvement After the Last Injection', 'timeFrame': 'Baseline; within 30 days after the last injection', 'description': 'Clinical Improvement is defined as \\>= 50% reduction from baseline in degree of contracture within 30 days of the injection.'}, {'measure': 'Percent Reduction From Baseline Contracture After the Last Injection', 'timeFrame': 'Baseline; within 30 days after the last injection', 'description': 'Percent change in degree of contracture measured as 100\\* (baseline contracture - last available post-injection contracture)/baseline contracture.'}, {'measure': 'Change From Baseline Range of Motion After the Last Injection', 'timeFrame': 'Baselin; within 30 days after the last injection', 'description': 'Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.'}, {'measure': 'Time to First Achieve Success After the Last Injection', 'timeFrame': 'Last evaluation visit on which clinical success is achieved through the Day 30 evaluation'}, {'measure': 'Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection', 'timeFrame': 'Within 30 days after first injection', 'description': 'Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.'}, {'measure': 'Clinical Improvement After the First Injection', 'timeFrame': 'Baseline; within 30 days after the first injection', 'description': 'Clinical Improvement is defined as \\>= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.'}, {'measure': 'Percent Reduction From Baseline Contracture After the First Injection', 'timeFrame': 'Baseline, within 30 days after the first injection', 'description': 'Percent change in degree of contracture measured as 100\\* (baseline contracture - last available post-injection contracture)/baseline contracture.'}, {'measure': 'Change From Baseline Range of Motion After the First Injection', 'timeFrame': 'Baseline; within 30 days after the first injection', 'description': 'Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Dupuytren's Contracture"]}, 'referencesModule': {'references': [{'pmid': '21967070', 'type': 'DERIVED', 'citation': "Witthaut J, Bushmakin AG, Gerber RA, Cappelleri JC, Le Graverand-Gastineau MP. Determining clinically important changes in range of motion in patients with Dupuytren's Contracture: secondary analysis of the randomized, double-blind, placebo-controlled CORD I study. Clin Drug Investig. 2011 Nov 1;31(11):791-8. doi: 10.1007/BF03256918."}, {'pmid': '19726771', 'type': 'DERIVED', 'citation': "Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866."}], 'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf', 'label': 'XIAFLEX Prescribing Information'}]}, 'descriptionModule': {'briefSummary': "This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.\n\nThis study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a diagnosis of Dupuytren\'s contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had never been treated with AA4500.\n* Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.\n* Judged to be in good health.\n\nExclusion Criteria:\n\n* Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.\n* Had received a treatment for Dupuytren\'s contracture, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.\n* Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator\'s opinion, would make the subject unsuitable for enrollment in the study.'}, 'identificationModule': {'nctId': 'NCT00528606', 'acronym': 'CORD-I', 'briefTitle': "AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture", 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': "A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture", 'orgStudyIdInfo': {'id': 'AUX-CC-857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AA4500 0.58 mg', 'interventionNames': ['Biological: collagenase clostridium histolyticum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'collagenase clostridium histolyticum', 'type': 'BIOLOGICAL', 'otherNames': ['XIAFLEX®', 'AA4500'], 'description': 'Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.', 'armGroupLabels': ['AA4500 0.58 mg']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '100 UCLA Medical Plaza, Suite 305', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Hand Surgery Clinic', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Hand Surgery Associates, PC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Hand and Upper Extremity Center of Georgia, P.C.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates, Ltd.', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Hand Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital, Department of Orthopedic Surgery", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Newton-Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '55431', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'TRIA Orthopaedic Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook - Department of Orthopedics', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '73109', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Health Research Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '16550', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hand Microsurgery & Reconstructive Orthopaedics', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Department of Orthopaedics, Brown University, Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Veronica Urdaneta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}