Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-07 @ 10:00 PM
Study NCT ID:
NCT00485433
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ErolOnel@pacira.com', 'phone': '203-837-6500', 'title': 'Executive Medical Director', 'organization': 'Pacira Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bupivacaine HCl 105mg', 'description': 'Bupivacaine HCl given during hernia repair', 'otherNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SKY0402 (All Doses)', 'description': 'SKY0402 given during hernia repair', 'otherNumAtRisk': 74, 'otherNumAffected': 17, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Scar', 'notes': 'Occurred in the Low Dose group', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine HCl 105mg', 'description': 'A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery'}, {'id': 'OG001', 'title': 'SKY0402 Low Dose', 'description': 'A single dose of SKY0402 105mg diluted to a 42-mL injection volume administered via local infiltration during surgery'}, {'id': 'OG002', 'title': 'SKY0402 Middle Dose', 'description': 'A single dose of SKY0402 180mg diluted to a 42-mL injection volume administered via local infiltration during surgery'}, {'id': 'OG003', 'title': 'SKY0402 High Dose', 'description': 'A single dose of SKY0402 345 mg diluted to a 42-mL injection volume administered via local infiltration during surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '298.1', 'spread': '136.6', 'groupId': 'OG000'}, {'value': '286.9', 'spread': '146.4', 'groupId': 'OG001'}, {'value': '274.6', 'spread': '115.4', 'groupId': 'OG002'}, {'value': '274.4', 'spread': '253.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 72 hours', 'description': 'The subject\'s pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"', 'unitOfMeasure': 'Units on a scale*hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days', 'timeFrame': 'Up to 30 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupivacaine HCl 105mg', 'description': 'Bupivacaine HCl given during hernia repair'}, {'id': 'FG001', 'title': 'SKY0402 Low Dose', 'description': 'SKY0402 low dose given during hernia repair'}, {'id': 'FG002', 'title': 'SKY0402 Middle Dose', 'description': 'SKY0402 middle dose given during hernia repair'}, {'id': 'FG003', 'title': 'SKY0402 High Dose', 'description': 'SKY0402 high dose given during hernia repair'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupivacaine HCl 105mg', 'description': 'Bupivacaine HCl given during hernia repair'}, {'id': 'BG001', 'title': 'SKY0402 Low Dose', 'description': 'SKY0402 low dose given during hernia repair'}, {'id': 'BG002', 'title': 'SKY0402 Middle Dose', 'description': 'SKY0402 middle dose given during hernia repair'}, {'id': 'BG003', 'title': 'SKY0402 High Dose', 'description': 'SKY0402 high dose given during hernia repair'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '16.9', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '17.3', 'groupId': 'BG001'}, {'value': '54', 'spread': '15.1', 'groupId': 'BG002'}, {'value': '52.1', 'spread': '15.6', 'groupId': 'BG003'}, {'value': '51.1', 'spread': '16.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2010-08-25', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2007-06-11', 'dispFirstSubmitQcDate': '2010-09-03', 'resultsFirstSubmitDate': '2011-11-23', 'studyFirstSubmitQcDate': '2007-06-11', 'dispFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-03', 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours', 'timeFrame': '0 to 72 hours', 'description': 'The subject\'s pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days', 'timeFrame': 'Up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hernia', 'unilateral', 'postoperative', 'analgesia'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '22900785', 'type': 'DERIVED', 'citation': 'Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.', 'detailedDescription': 'Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males 18 years of age and older at the Screening Visit.\n2. Scheduled to undergo, elective, primary, unilateral, open-technique, tension-free (Lichtenstein-type technique with mesh) inguinal hernia repair under general anesthesia.\n3. American Society of Anesthesiology (ASA) Physical Class 1-3.\n4. Capable and willing to comply with all study visits and procedures and to provide written informed consent.\n5. Able to speak, read, and understand the language of the informed consent form, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.\n\nExclusion Criteria:\n\n1. Use of any of the following medications within the times specified before surgery:\n\n * Long-acting opioid medication within 3 days.\n * Any opioid medication within 24 hours.\n2. Concurrent painful physical condition that may require analgesic treatment in the postoperative period for pain that is not strictly related to the hernia repair procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, neuropathic pain, concomitant vasectomy).\n3. Body weight less than 50 kilograms.\n4. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.\n5. Other contraindication to bupivacaine.\n6. Contraindication(s) to epinephrine, such as concurrent administration of monoamine oxidase (MAO) inhibitors or antidepressants of amitriptyline or imipramine types, conditions where the production or exacerbation of tachycardia could prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other pathological conditions that might be aggravated by the effects of epinephrine.\n7. Contraindication to any of the pain control agents anticipated to be used postoperatively (i.e., acetaminophen or oxycodone).\n8. Administration of an investigational product within 30 days or 5 elimination half-lives of such investigational product, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.\n9. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.\n11. Current or historical evidence of any clinically significant condition that, in the opinion of the Investigator, may increase the risk of surgery, complicate the subject's postoperative course, or indicate an increased vulnerability to study drugs and procedures and expose the subject to an unreasonable risk as a result of participating in this clinical trial.\n\n If during surgery the following criterion is met:\n12. Any clinically significant event or condition uncovered during the hernia repair surgery (e.g., excessive bleeding) that might render the subject medically unstable or complicate the subject's postoperative course."}, 'identificationModule': {'nctId': 'NCT00485433', 'briefTitle': 'Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacira Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair.', 'orgStudyIdInfo': {'id': 'SKY0402-C-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine HCl 105mg', 'description': 'Bupivacaine HCl given during hernia repair', 'interventionNames': ['Drug: Bupivacaine HCl']}, {'type': 'EXPERIMENTAL', 'label': 'SKY0402 low dose', 'description': 'SKY0402 low dose given during hernia repair', 'interventionNames': ['Drug: SKY0402']}, {'type': 'EXPERIMENTAL', 'label': 'SKY0402 Middle dose', 'description': 'SKY0402 middle dose given during hernia repair', 'interventionNames': ['Drug: SKY0402']}, {'type': 'EXPERIMENTAL', 'label': 'SKY0402 High dose', 'description': 'SKY0402 high dose given during hernia repair', 'interventionNames': ['Drug: SKY0402']}], 'interventions': [{'name': 'Bupivacaine HCl', 'type': 'DRUG', 'otherNames': ['Marcaine 0.25% with epinephrine 1:200,000'], 'description': 'Bupivacaine HCl given during hernia repair', 'armGroupLabels': ['Bupivacaine HCl 105mg']}, {'name': 'SKY0402', 'type': 'DRUG', 'otherNames': ['EXPAREL'], 'description': 'SKY0402 given during hernia repair', 'armGroupLabels': ['SKY0402 High dose', 'SKY0402 Middle dose', 'SKY0402 low dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Arcadia Methodist Hospital', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Valley Outpatient Surgery', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Memorial Hospital', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's Roosevelt Hosptial Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Healthcare System', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Kirby Outpatient Surgical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}