Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 9:05 AM
Study NCT ID:
NCT01139866
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Summaries: Pain Intensity on Movement Evaluation; Surgical Site Healing and Local Tissue Evaluation; Shoulder Examination; MRI; Medical History Update; Adverse Events; and Concomitant Medications', 'timeFrame': '18 months post-dose in C803-017 trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Long-term Safety', 'Shoulder Surgery', 'bupivacaine'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': "This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental pain-relieving medication). The purpose of this extension trial is to assess whether treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the participant's shoulder, wound, or the skin near their scar. This trial will also assess safety (side effects).", 'detailedDescription': 'This research trial will involve all available subjects who received treatment in DURECT Protocol C803-017. All subjects will have the same follow-up safety assessments performed. No experimental treatment will be given in this trial. Subjects, Investigators, and caregivers will remain blinded to the treatment subjects received in the previous trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All available subjects who received treatment in DURECT protocol C803-017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have provided written consent to participate in the trial prior to any trial procedures and understand that they are free to withdraw from the trial at any time.\n* Participants must be able to read and understand the consent form, complete trial-related procedures, and communicate with the trial staff.\n* Participants must have participated in DURECT Protocol C803-017 and received SABER™-Bupivacaine or SABER™-Placebo approximately 18 months before enrolling in this trial.\n\nExclusion Criteria:\n\n* Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.'}, 'identificationModule': {'nctId': 'NCT01139866', 'briefTitle': 'An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Durect'}, 'officialTitle': 'A Multi-Center, Prospective, Observational, Extension Trial Following DURECT Protocol C803-017 to Investigate the Long-term Safety of SABER™-Bupivacaine Following Arthroscopic Shoulder Surgery', 'orgStudyIdInfo': {'id': 'C803-017e'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: SABER™-Bupivacaine', 'description': 'Received 5.0 mL SABER™-Bupivacaine in previous C803-017 trial'}, {'label': 'Group 2: SABER™-Placebo', 'description': 'Received 5.0 mL SABER™-Placebo in previous C803-017 trial'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5065', 'city': 'Toorak Gardens', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -34.93478, 'lon': 138.63639}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3135', 'city': 'Ringwood East', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.81667, 'lon': 145.25}}, {'zip': '8014', 'city': 'Christchurch', 'country': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Hamilton', 'country': 'New Zealand', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'overallOfficials': [{'name': 'Dmitri Lissin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Durect'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Durect', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nycomed', 'class': 'INDUSTRY'}, {'name': 'Hospira, now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}