Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-02 @ 7:13 AM
Study NCT ID:
NCT00402792
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2006-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006853', 'term': 'Hydrocodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2006-11-20', 'studyFirstSubmitQcDate': '2006-11-21', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration.', 'timeFrame': '12 hours', 'description': 'Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Time-interval weighted sum of pain relief (TOTPAR)', 'timeFrame': '12 hours'}, {'measure': 'Time-interval weighted sum of pain relief and pain intensity difference (SPRID)', 'timeFrame': '12 hours'}, {'measure': 'Perceptible pain relief', 'timeFrame': '12 hours'}, {'measure': 'Meaningful pain relief', 'timeFrame': '12 hours'}, {'measure': 'Pain relief (PR)', 'timeFrame': '12 hours'}, {'measure': 'Pain intensity (PI)', 'timeFrame': '12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute pain following bunionectomy surgery'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ages 18 to 65\n* Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery\n* Meet specific pain intensity criteria on the morning after surgery\n* Willing to be confined for 4 days following surgery\n* If female, must be of non-child bearing potential or practicing birth control\n\nExclusion Criteria:\n\n* Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs\n* Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)\n* Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract\n* Has specific active or uncontrolled seizure disorders\n* Has been diagnosed with certain cancers within the past 5 years\n* Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression\n* Has specific clinically significant illnesses or laboratory abnormalities\n* Has received corticosteroid treatment or any investigational drug within a specific timeframe'}, 'identificationModule': {'nctId': 'NCT00402792', 'briefTitle': 'A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy', 'orgStudyIdInfo': {'id': 'M05-765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: hydrocodone / acetaminophen extended release', 'interventionNames': ['Drug: Hydrocodone/Acetaminophen Extended-Release']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: hydrocodone / acetaminophen extended release', 'interventionNames': ['Drug: Hydrocodone/Acetaminophen Extended Release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hydrocodone/Acetaminophen Extended-Release', 'type': 'DRUG', 'otherNames': ['ABT-712', 'hydrocodone / acetaminophen extended release'], 'description': '1 tablet q 12 hours', 'armGroupLabels': ['Arm 1: hydrocodone / acetaminophen extended release']}, {'name': 'Hydrocodone/Acetaminophen Extended Release', 'type': 'DRUG', 'otherNames': ['ABT-712', 'hydrocodone / acetaminophen extended release'], 'description': '2 tablets q 12 hours', 'armGroupLabels': ['Arm 2: hydrocodone / acetaminophen extended release']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 tablets q 12 hours', 'armGroupLabels': ['Arm 3: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2589', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2587', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2586', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2588', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '84094', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2585', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Rita Jain, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Andrea Best, DO, MPH', 'oldOrganization': 'Abbott'}}}}