Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-30 @ 5:00 PM
Study NCT ID:
NCT00683267
Status:
TERMINATED
Last Update Posted:
2009-05-04
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C528652', 'term': 'ALGRX-4975'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'whyStopped': 'Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-01', 'studyFirstSubmitDate': '2008-05-21', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', '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 endpoints, safety and tolerability of 4975', 'timeFrame': '42 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['THA, Total hip arthroplasty, total hip replacement'], 'conditions': ['Arthroplasty']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.anesiva.com/wt/page/pipeline', 'label': 'Anesiva Home page'}, {'url': 'http://www.anesiva.com/wt/page/adlea', 'label': 'ADLEA Product Information'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement', 'detailedDescription': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip 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, III\n* Planning to undergo unilateral THA\n* In good health and capable of undergoing THA with spinal block and sedation anesthesia\n* No additional planned surgeries during the course of the trial\n* Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English\n\nKey Exclusion Criteria:\n\n* A body mass index greater than 40\n* Known bleeding disorder or is taking agents affecting coagulation preoperatively\n* A medical condition that could adversely impact the patient's participation, safety, or conduct of the study\n* Diabetes mellitus with a known HbA1C\\>9.5 or a history of prolonged uncontrolled diabetes\n* Previous hip arthroplasty of the same hip\n* Participated in another clinical trial within 30 days of the planned hip surgery"}, 'identificationModule': {'nctId': 'NCT00683267', 'briefTitle': 'Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anesiva, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '114-03P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Study treatment, 4975, is instilled directly into surgical site', 'interventionNames': ['Drug: 4975, highly purified capsaicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo is instilled directly into surgical site', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '4975, highly purified capsaicin', 'type': 'DRUG', 'otherNames': ['4975, Adlea'], 'description': 'One dose administered by direct instillation into the surgical site', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One dose administered by direct instillation into the surgical site', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research, Inc.', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Adventist Medical Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Webster Orthopaedic Medical Group', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco - Mt. Zion', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Medical Research, Inc.', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '15143', 'city': 'Sewickley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sewickley Valley Hospial', 'geoPoint': {'lat': 40.53646, 'lon': -80.1845}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Covenant Medical Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Shaun Comfort, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anesiva, Inc.'}, {'name': 'William Houghton, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anesiva, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anesiva, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Shaun Comfort, MD', 'oldOrganization': 'Anesiva, Inc.'}}}}