Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-31 @ 11:28 AM
Study NCT ID:
NCT01102660
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542398', 'term': 'PH 797804'}, {'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'dispFirstSubmitDate': '2012-10-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2010-04-12', 'dispFirstSubmitQcDate': '2012-10-01', 'studyFirstSubmitQcDate': '2010-04-12', 'dispFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario & McMaster Osteoarthritis Index Pain Score', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Western Ontario & McMaster Osteoarthritis Index Stiffness Score', 'timeFrame': '2 weeks'}, {'measure': 'Western Ontario & McMaster Osteoarthritis Index Physical Function Score', 'timeFrame': '2 weeks'}, {'measure': 'Western Ontario & McMaster Osteoarthritis Index Total Score', 'timeFrame': '2 weeks'}, {'measure': 'Daily Pain Rating Scale', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee osteoarthritis', 'clinical trial', 'cross-over'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631026&StudyName=Clinical%20Trial%20to%20Examine%20the%20Pain%20Relief%20of%20PH-797804%20Alone%20Or%20with%20Naproxen%20in%20Subjects%20with%20Osteoarthritis%20of%20the%20Knee', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.\n* Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.\n\nExclusion Criteria:\n\n* History of diseases other than osteoarthritis that may involve the index knee.\n* Other severe pain that impairs the assessment of osteoarthritis of pain.\n* Electrocardiogram abnormalities.\n* History of gastrointestinal disorders.'}, 'identificationModule': {'nctId': 'NCT01102660', 'briefTitle': 'Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee', 'orgStudyIdInfo': {'id': 'A6631026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Sequence 1', 'interventionNames': ['Drug: PH-797804', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Treatment Sequence 2', 'interventionNames': ['Drug: Placebo', 'Drug: PH-797804']}, {'type': 'OTHER', 'label': 'Treatment Sequence 3', 'interventionNames': ['Drug: Naproxen', 'Drug: Naproxen + PH-797804']}, {'type': 'OTHER', 'label': 'Treatment Sequence 4', 'interventionNames': ['Drug: Naproxen + PH-797804', 'Drug: Naproxen']}], 'interventions': [{'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg once daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet, 0 mg once daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet, 0 mg once daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 2']}, {'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg once daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 2']}, {'name': 'Naproxen', 'type': 'DRUG', 'description': 'Tablet, 500 mg twice daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 3']}, {'name': 'Naproxen + PH-797804', 'type': 'DRUG', 'description': 'Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 3']}, {'name': 'Naproxen + PH-797804', 'type': 'DRUG', 'description': 'Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 4']}, {'name': 'Naproxen', 'type': 'DRUG', 'description': 'Tablet, 500 mg twice daily for 2 weeks', 'armGroupLabels': ['Treatment Sequence 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.88946, 'lon': 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