Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-26 @ 8:48 AM
Study NCT ID:
NCT00584168
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Dexamethasone After Uvulopalatopharyngoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantifying patient treatment with a questionaire. Patient will rate their satisfaction with pain management.', 'timeFrame': 'Eleven days post-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['UPPP', 'Dexamethasone', 'Uvulopalatopharyngoplasty', 'Pain Management', 'Increasing pain management in patients that have undergone UPPP surgery'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study looks at lessening the pain after a Uvulopalatopharyngoplasty (UPPP) surgery by using Dexamethasone (a corticosteroid).', 'detailedDescription': "The study was designed because patients have a lot of pain after they have a UPPP. Certain drugs called steroids may lessen the pain associated from this surgery. This study uses Dexamethasone (a corticosteroid), to see if it will help reduce pain, decrease the amount of time until the patient can begin to eat or return to normal activity, or increase their satisfaction with pain management. In this study the patients will be randomized (computer chosen) to receive either the study drug (dexamethasone), or a placebo. The patient will start the day before surgery with a single pill. They will then receive the dexamethasone or a placebo twice daily for the next four days and then once daily for the next two days for a total of seven days. Afterward, they will be asked to complete a questionnaire. The five questions ask patients to access the amount of pain they have, how much of their normal diet or activity they have returned to, and how much pain medication they have taken. At the next follow-up visit they will be asked to complete another questionaire (9 questions) about the patient's satisfaction with pain management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates scheduled for UPPP surgery.\n* Able to take steroids\n\nExclusion Criteria:\n\n* Those patients who unable to take steroids'}, 'identificationModule': {'nctId': 'NCT00584168', 'briefTitle': 'Using Dexamethasone After Uvulopalatopharyngoplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Decreasing Morbidity After Uvulopalatopharyngoplasty With the Use of Dexamethasone - A Randomized Double Blinded Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'Dexamethasone, UPPP - Houck'}, 'secondaryIdInfos': [{'id': 'UPPP Study, IRB # 12098', 'type': 'OTHER', 'domain': 'Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Patient will receive a placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patient will receive dexamethasone.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'John Houck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}