Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-28 @ 1:47 AM
Study NCT ID:
NCT00390260
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2006-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
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': 'C116926', 'term': 'rofecoxib'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}, {'id': 'D006853', 'term': 'Hydrocodone'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'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': {'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2006-10-18', 'studyFirstSubmitQcDate': '2006-10-18', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Pain Relief over 6 hours following a single oral dose compared to placebo.', 'timeFrame': '6 hours'}], 'secondaryOutcomes': [{'measure': 'Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.', 'timeFrame': '6 hours'}]}, 'conditionsModule': {'conditions': ['Pain, Postoperative Arthroscopy']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '17207303', 'type': 'BACKGROUND', 'citation': 'Chelly JE, Nissen CW, Rodgers AJ, Smugar SS, Tershakovec AM. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007 Jan;23(1):195-206. doi: 10.1185/030079907X162647.'}]}, 'descriptionModule': {'briefSummary': 'Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective outpatient arthroscopic knee surgery expected to last \\<= 90 minutes using general anesthesia\n* Patients must experience moderate to severe pain following surgery\n* Patient must be in general good health as judged by the primary investigator\n\nExclusion Criteria:\n\n* Osteoarthritis; rheumatoid arthritis\n* Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen\n* Asthma associated with nasal polyps\n* Any arthroscopic knee surgery in the past 6 months'}, 'identificationModule': {'nctId': 'NCT00390260', 'briefTitle': 'Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain', 'orgStudyIdInfo': {'id': '0966-179'}, 'secondaryIdInfos': [{'id': '2006_535'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0966 / Duration of Treatment: 1 Days', 'type': 'DRUG'}, {'name': 'Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days', 'type': 'DRUG'}, {'name': 'Comparator: placebo (unspecified) / Duration of Treatment: 1 Days', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}