Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT00140933
Status:
TERMINATED
Last Update Posted:
2006-12-05
First Post:
2005-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 274}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'lastUpdateSubmitDate': '2006-12-01', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain during daily activities assessed by a Numerical Rating Score (NRS)'}], 'secondaryOutcomes': [{'measure': "Functional impairment evaluated using Neer's functional index."}, {'measure': 'Global assessment of disease activity by the patient with a NRS.'}, {'measure': 'Intensity of night pain evaluated by NRS.'}, {'measure': 'Rescue treatment take during the study duration.'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '32797734', 'type': 'DERIVED', 'citation': 'Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.'}, 'identificationModule': {'nctId': 'NCT00140933', 'briefTitle': 'A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome', 'orgStudyIdInfo': {'id': '2005_056'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0966; rofecoxib', 'type': 'DRUG'}, {'name': 'Comparator: diclofenac, placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75114', 'city': 'Paris', 'country': 'France', 'facility': 'Laboratoires Merck Sharp & Dohme - Chibret', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}}}}