Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-03-07 @ 10:43 PM
Study NCT ID:
NCT00663767
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592910', 'term': 'ARRY-371797'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D052246', 'term': 'Cyclooxygenase 2 Inhibitors'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D016861', 'term': 'Cyclooxygenase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2009-12-09', 'completionDateStruct': {'date': '2008-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-07', 'studyFirstSubmitDate': '2008-04-18', 'dispFirstSubmitQcDate': '2009-12-09', 'studyFirstSubmitQcDate': '2008-04-21', 'dispFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).', 'timeFrame': '6 hours post-dose'}, {'measure': 'Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.', 'timeFrame': 'Duration of study'}], 'secondaryOutcomes': [{'measure': 'Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication].', 'timeFrame': 'Duration of study'}]}, 'conditionsModule': {'conditions': ['Dental Pain']}, 'descriptionModule': {'briefSummary': "This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone.\n* Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.\n* Body weight \\>50 kg (110 lbs).\n* Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.\n* Additional criteria exist.\n\nKey Exclusion Criteria:\n\n* Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).\n* Positive urine drug screen within 28 days prior to first dose of study drug.\n* Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).\n* Additional criteria exist.'}, 'identificationModule': {'nctId': 'NCT00663767', 'briefTitle': 'A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction', 'orgStudyIdInfo': {'id': 'ARRAY-797-222'}, 'secondaryIdInfos': [{'id': 'C4411009', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo; oral']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, ARRY-371797', 'interventionNames': ['Drug: Placebo; oral', 'Drug: ARRY-371797, p38 inhibitor; oral']}, {'type': 'EXPERIMENTAL', 'label': 'ARRY-371797, Placebo', 'interventionNames': ['Drug: ARRY-371797, p38 inhibitor; oral', 'Drug: Placebo; oral']}, {'type': 'EXPERIMENTAL', 'label': 'ARRY-371797', 'interventionNames': ['Drug: ARRY-371797, p38 inhibitor; oral']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib, Placebo', 'interventionNames': ['Drug: Celecoxib, COX-2 inhibitor; oral', 'Drug: Placebo; oral']}, {'type': 'EXPERIMENTAL', 'label': 'Celecoxib, ARRY-371797', 'interventionNames': ['Drug: Celecoxib, COX-2 inhibitor; oral', 'Drug: ARRY-371797, p38 inhibitor; oral']}], 'interventions': [{'name': 'Placebo; oral', 'type': 'DRUG', 'description': 'dose 1, dose 2', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo; oral', 'type': 'DRUG', 'description': 'dose 1', 'armGroupLabels': ['Placebo, ARRY-371797']}, {'name': 'ARRY-371797, p38 inhibitor; oral', 'type': 'DRUG', 'description': 'dose 1: multiple dose levels', 'armGroupLabels': ['ARRY-371797, Placebo']}, {'name': 'ARRY-371797, p38 inhibitor; oral', 'type': 'DRUG', 'description': 'dose 1: multiple dose levels; dose 2', 'armGroupLabels': ['ARRY-371797']}, {'name': 'Celecoxib, COX-2 inhibitor; oral', 'type': 'DRUG', 'description': 'dose 1', 'armGroupLabels': ['Celecoxib, ARRY-371797', 'Celecoxib, Placebo']}, {'name': 'Placebo; oral', 'type': 'DRUG', 'description': 'dose 2', 'armGroupLabels': ['ARRY-371797, Placebo', 'Celecoxib, Placebo']}, {'name': 'ARRY-371797, p38 inhibitor; oral', 'type': 'DRUG', 'description': 'dose 2', 'armGroupLabels': ['Celecoxib, ARRY-371797', 'Placebo, ARRY-371797']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Phase I Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Lifetree Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}