Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-04 @ 9:18 PM
Study NCT ID:
NCT00681356
Status:
COMPLETED
Last Update Posted:
2009-05-04
First Post:
2008-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C528652', 'term': 'ALGRX-4975'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-01', 'studyFirstSubmitDate': '2008-05-16', 'studyFirstSubmitQcDate': '2008-05-16', 'lastUpdatePostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS) measures of pain at prespecified times', 'timeFrame': 'Primary endpoint is 2 days (4-48 hours)'}], 'secondaryOutcomes': [{'measure': 'Other efficacy parameters, safety and tolerability of 4975', 'timeFrame': '42 Days or Early Termination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TKA', 'Total knee arthroplasty', 'Total knee replacement', 'Knee surgery'], 'conditions': ['Total Knee Arthroplasty (Replacement)']}, 'referencesModule': {'references': [{'pmid': '21971213', 'type': 'DERIVED', 'citation': 'Hartrick CT, Pestano C, Carlson N, Hartrick S. Capsaicin instillation for postoperative pain following total knee arthroplasty: a preliminary report of a randomized, double-blind, parallel-group, placebo-controlled, multicentre trial. Clin Drug Investig. 2011 Dec 1;31(12):877-82. doi: 10.1007/BF03256925.'}], 'seeAlsoLinks': [{'url': 'http://www.anesiva.com/wt/page/pipeline', 'label': 'Anesiva, Inc. Home Page'}, {'url': 'http://www.anesiva.com/wt/page/adlea', 'label': 'ADLEA Product Information'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement', 'detailedDescription': 'The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, or III\n* Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)\n\nKey Exclusion Criteria:\n\n* A body mass index (BMI) greater than 43\n* Known bleeding disorder or is taking agents affecting coagulation preoperatively\n* Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments\n* Diabetes mellitus with a known HbA1C\\>9.5 or a history of prolonged uncontrolled diabetes\n* Previous knee arthroplasty (partial or total) of the same knee\n* Participated in another clinical trial within 30 days prior to the planned TKA surgery"}, 'identificationModule': {'nctId': 'NCT00681356', 'briefTitle': 'Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anesiva, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '114-01P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '4975 - 15 mg', 'interventionNames': ['Drug: 4975, 15 and 5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo Comparator']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '4975 - truncated for Phase 3', 'interventionNames': ['Drug: 4975 - 5 mg']}], 'interventions': [{'name': '4975, 15 and 5 mg', 'type': 'DRUG', 'otherNames': ['Adlea'], 'description': 'Direct instillation into the surgical site', 'armGroupLabels': ['1']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Direct instillation into the surgical site', 'armGroupLabels': ['2']}, {'name': '4975 - 5 mg', 'type': 'DRUG', 'description': 'Direct instillation into the surgical site', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Springhill Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Hellen Keller Hospital', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research/Tucson Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Adventist Medical Center - Lotus Clinical Research', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Physicians Clinical Research Corporation', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Memorial Medical Center/Accurate Clinical Trials', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Webster Orthopeadic Medical Group', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF-Mt. 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