Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 2:07 AM
Study NCT ID:
NCT00672568
Status:
TERMINATED
Last Update Posted:
2009-05-04
First Post:
2008-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder
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': 24}}, 'statusModule': {'whyStopped': 'Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-01', 'studyFirstSubmitDate': '2008-05-02', 'studyFirstSubmitQcDate': '2008-05-02', 'lastUpdatePostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery', 'timeFrame': '28 Days'}], 'secondaryOutcomes': [{'measure': 'Mean overall daily pain and worst daily pain. Pain intensity with physical therapy. Safety outcomes include ECG, vital signs, adverse drug reactions, and wound exams', 'timeFrame': '28 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rotator cuff, Shoulder, Arthroscopic shoulder surgery'], 'conditions': ['Rotator Cuff Repair of the Shoulder']}, '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': 'The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder', 'detailedDescription': 'This is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study in patients undergoing arthroscopic rotator cuff repair surgery.\n\nStage 1) Patients will be randomized to receive either 4975 or placebo. The dose of 4975 will be escalated in a protocolized manner based on safety and tolerability.\n\nStage 2) Patients will be randomized in a 1:1 ratio to receive either the selected dose of 4975 or placebo. All patients will be observed in the hospital for at least two days following surgery for safety, tolerability, and efficacy assessments. In addition there will be two planned follow-up visits after hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female between the ages of 18 and 75 inclusive\n* In overall good health and planning to undergo unilateral arthroscopic shoulder surgery to repair at least one rotator cuff tendon involving humeral attachment\n* Willing and able to complete the study procedures, pain assessments, and medication diaries, and to communicate in Korean or English with study personnel\n\nKey Exclusion Criteria:\n\n* Shoulder surgery requiring concomitant repair of biceps muscle or associated tendon(s)\n* Planning to undergo shoulder surgery on both shoulders\n* Use of disallowed pain medications prior to the surgery\n* Female patients who are pregnant or lactating or who plan to get pregnant\n* Diabetes mellitus with a known HbA1C\\>9.5'}, 'identificationModule': {'nctId': 'NCT00672568', 'briefTitle': 'Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anesiva, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Stage Exploratory Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of Intraoperative Subacromial Injection With 4975 in Patients Undergoing Arthroscopic Rotator Cuff Repair of the Shoulder', 'orgStudyIdInfo': {'id': '114-04P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '4975', 'interventionNames': ['Drug: 4975 - Highly purified capsaicin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '4975', 'interventionNames': ['Drug: 4975 - Highly purified capsaicin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '4975', 'interventionNames': ['Drug: 4975 - Highly purified capsaicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '4975 - Highly purified capsaicin', 'type': 'DRUG', 'otherNames': ['Adlea'], 'description': 'Solution, 0.5 mg, single dose, injection', 'armGroupLabels': ['1']}, {'name': '4975 - Highly purified capsaicin', 'type': 'DRUG', 'otherNames': ['Adlea'], 'description': 'Solution, 0.75 mg, single dose, injection', 'armGroupLabels': ['2']}, {'name': '4975 - Highly purified capsaicin', 'type': 'DRUG', 'otherNames': ['Adlea'], 'description': 'Solution, 0.1 mg, Single dose, injection', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution, single dose, injection', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Daegu', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'Kyungpook National university Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '463-707', 'city': 'Seoul', 'state': 'Kyunggido', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '660-720', 'city': 'Jinju', 'state': 'Kyungsangnamdo', 'country': 'South Korea', 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '137-040', 'city': 'Seoul', 'state': 'Seocho-gu', 'country': 'South Korea', 'facility': "Kangnam St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Shaun Comfort, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anesiva, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anesiva, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Shaun Comfort, MD', 'oldOrganization': 'Anesiva, Inc.'}}}}