Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-23 @ 8:30 PM
Study NCT ID:
NCT00542035
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2007-10-05
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'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592910', 'term': 'ARRY-371797'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2009-12-09', 'completionDateStruct': {'date': '2008-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2007-10-05', 'dispFirstSubmitQcDate': '2009-12-09', 'studyFirstSubmitQcDate': '2007-10-05', 'dispFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).', 'timeFrame': '6 hours post dose 2'}, {'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': 'Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).', 'timeFrame': 'Duration of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Analgesia'], '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 either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral 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* Positive urine drug screen.\n* Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.\n* Additional criteria exist.'}, 'identificationModule': {'nctId': 'NCT00542035', 'briefTitle': 'A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP ANALGESIC EFFICACY TRIAL OF ORAL ARRY-371797 IN SUBJECTS UNDERGOING THIRD MOLAR EXTRACTION', 'orgStudyIdInfo': {'id': 'ARRAY-797-221'}, 'secondaryIdInfos': [{'id': 'C4411008', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARRY-371797', 'interventionNames': ['Drug: ARRY-371797, p38 inhibitor; oral']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, ARRY-371797', 'interventionNames': ['Drug: Placebo; oral', 'Drug: ARRY-371797, p38 inhibitor; oral']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo; oral']}], 'interventions': [{'name': 'ARRY-371797, p38 inhibitor; oral', 'type': 'DRUG', 'description': 'dose 1, dose 2', 'armGroupLabels': ['ARRY-371797']}, {'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 2', 'armGroupLabels': ['Placebo, ARRY-371797']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'SCIREX Research Center', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'SCIREX Research Center', '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'}}}}