Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 7:16 PM
Study NCT ID:
NCT00981357
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C560620', 'term': 'N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2011-06-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2009-09-21', 'dispFirstSubmitQcDate': '2011-06-02', 'studyFirstSubmitQcDate': '2009-09-21', 'dispFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee', 'timeFrame': '8 weeks'}, {'measure': 'To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee.', 'timeFrame': '8 weeks'}, {'measure': 'Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee.', 'timeFrame': '8 weeks'}, {'measure': 'Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.', 'timeFrame': '8 weeks'}, {'measure': 'Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee.', 'timeFrame': '8 weeks'}, {'measure': 'Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Daily pain diary over weeks 1 and 2 of each treatment period using an 11-point Numeric Rating Scale (NRS) in patients with osteoarthritis of the knee.', 'timeFrame': '8 weeks'}, {'measure': "Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment.", 'timeFrame': '8 weeks'}, {'measure': 'Summary of plasma concentrations of PF-04457845.', 'timeFrame': '8 weeks'}, {'measure': 'Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis.', 'timeFrame': '8 weeks'}, {'measure': 'Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0541004&StudyName=A%20Study%20To%20Investigate%20Whether%20PF-04457845%20Is%20Effective%20In%20Treating%20Pain%2C%20Is%20Safe%20And%20Tolerable%20In%20Patients%20With%20Osteoarthritis%20Of%20T', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray\n* Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)\n* Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant\n\nExclusion Criteria:\n\n* Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments'}, 'identificationModule': {'nctId': 'NCT00981357', 'briefTitle': 'A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2a Randomized, Double-blinded, Double Dummy, Placebo And Active Controlled, Two-way Cross-over, Flare-enriched Multi-centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A Fatty Acid Amide Hydrolase (Faah) Inhibitor Pf-04457845 In Patients With Osteoarthritis Of The Knee.', 'orgStudyIdInfo': {'id': 'B0541004'}, 'secondaryIdInfos': [{'id': '2009-014734-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04457845 followed by placebo', 'interventionNames': ['Drug: PF-04457845']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo followed by PF-04457845', 'interventionNames': ['Drug: PF-04457845']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naproxen followed by placebo', 'interventionNames': ['Drug: Naproxen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo followed by Naproxen', 'interventionNames': ['Drug: Naproxen']}], 'interventions': [{'name': 'PF-04457845', 'type': 'DRUG', 'description': 'PF-04457845 4 mg tablet once daily / matched placebo', 'armGroupLabels': ['PF-04457845 followed by placebo']}, {'name': 'PF-04457845', 'type': 'DRUG', 'description': 'PF-04457845 4 mg tablet once daily / matched placebo', 'armGroupLabels': ['Placebo followed by PF-04457845']}, {'name': 'Naproxen', 'type': 'DRUG', 'description': 'Naproxen 500 mg tablet twice daily / matched placebo', 'armGroupLabels': ['Naproxen followed by placebo']}, {'name': 'Naproxen', 'type': 'DRUG', 'description': 'Naproxen 500 mg tablet twice daily / matched placebo', 'armGroupLabels': ['Placebo followed by Naproxen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis & Rheumatic Care Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'CEDRA Clinical Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'J1H 1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Diex Research Inc.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '405 30', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Centrum for klinisk provning', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}