Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-02 @ 8:49 AM
Study NCT ID:
NCT00246168
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2005-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C478659', 'term': 'Ultracet'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-29', 'studyFirstSubmitDate': '2005-10-28', 'studyFirstSubmitQcDate': '2005-10-28', 'lastUpdatePostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily pain relief score'}], 'secondaryOutcomes': [{'measure': "Average daily pain intensity score; average pain relief and intensity score for the final visit; patient's assessment of physical function; overall assessment by the patient; overall assessment by the investigator; and an evaluation of safety"}]}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'NSAID add-on therapy', 'tramadol', 'acetaminophen'], 'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of ULTRACET® (a combination analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. Advil®, Motrin® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g. Celebrex®).', 'detailedDescription': "This is a randomized, multicenter, placebo-controlled, double-blind study to evaluate the efficacy and safety of ULTRACET® (tramadol 37.5 mg and acetaminophen 325 mg) as add-on therapy in rheumatoid arthritis patients taking an NSAID or a COX-2 inhibitor. The patients will be randomized into 2 treatment groups: The first group will receive one ULTRACET® tablet 3 times per day for 7 days. The second group will receive one placebo tablet 3 times per day for 7 days. The primary efficacy measurement will be the patients' average daily pain score. Safety will be monitored throughout the study. The study hypothesis is that ULTRACET® will be well tolerated and the average daily pain relief score for the ULTRACET® treatment group will be better than that of placebo group. Patients will take one ULTRACET® tablet or placebo by mouth 3 times per day, for 7 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with rheumatoid arthritis at least 6 months before the participation in the clinical trial, (defined by having more than 4 of the diagnosis criteria suggested by American College of Rheumatology (ACR\n* 1987))\n* have been on a stable daily dose of an NSAID or a COX-2 inhibitor for at least 30 days prior to the start of the study\n* have arthralgia (arthritis pain in the joints) for at least 2 days before the entering clinical trial, with a pain score on the Visual Analogue Scale (VAS) of 40 mm or greater.\n\nExclusion Criteria:\n\n* Have had an inadequate response to Tramadol HCl therapy, or have discontinued Tramadol HCl therapy due to adverse events\n* have taken Tramadol HCl within 30 days prior to study entry\n* have recently taken other medications for pain relief, (other than their daily NSAID or COX-2 inhibitor\n* daily use of aspirin at a dose greater than 100 mg per day.'}, 'identificationModule': {'nctId': 'NCT00246168', 'briefTitle': 'ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': 'ULTRACET (Tramadol Hydrochloride and Acetaminophen) add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'CR005929'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tramadol hydrochloride + acetaminophen', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen Korea, Ltd. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}}}}