Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 4:47 AM
Study NCT ID:
NCT01734759
Status:
COMPLETED
Last Update Posted:
2013-10-21
First Post:
2012-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Medication Taste on Pediatric Prescribers' Prescribing Habits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-18', 'studyFirstSubmitDate': '2012-11-17', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taste scores on the visual analog scale', 'timeFrame': 'Change from baseline in taste scores at 3 months', 'description': 'Medication taste scores on the visual analog scale before and after a medication tasting will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medication palatability', 'medication taste'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if a medication taste test influences the prescribing habits of pediatric prescribers at Mayo Clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* subjects possess prescriptive authority (e.g. MD, nurse practitioner, physician's assistant, medication therapy management pharmacists)\n* subjects have prescribed at least one of the study medications from one of the medication classes to pediatric patients at an outpatient clinic in the three months preceding the study\n\nExclusion Criteria:\n\n* subjects do not prescribe any of the tested medications\n* subject has an allergy to all of the study medications\n* subject is pregnant or breastfeeding\n* subject has a medical condition that prevents them from being involved in the taste test\n\nParticipants are advised to be within or accessible to the Rochester, MN area during study recruitment and accessible afterwards via mail, email or fax."}, 'identificationModule': {'nctId': 'NCT01734759', 'briefTitle': "Influence of Medication Taste on Pediatric Prescribers' Prescribing Habits", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Influence of Medication Palatability on Prescribing Habits of Pediatric Prescribers', 'orgStudyIdInfo': {'id': '12-005823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taste Test', 'interventionNames': ['Drug: Taste Test']}], 'interventions': [{'name': 'Taste Test', 'type': 'DRUG', 'description': 'Before the taste test each participant will fill out an informed consent form and an enrollment survey. Each participant will receive 0.5 mL of each study medication in the taste test. During the taste test each medication in a class will be labeled with a color name so as to prevent any bias from preconceived taste perception. They will record their perception of the medications taste on a visual analog scale (VAS). An anaphlyaxis kit will be on hand in case of emergencies. Between samples participants will cleanse their palate with a saltine cracker and 30 mL of water. 5 different classes of medications will be tested.\n\nMedications to be sampled and the corresponding dose of the test dose are:\n\n* Cephalosporins: cefdinir 12.5 mg, cefixime 10 mg\n* Penicillins: penicillin VK 12.5 mg, amoxicillin 12.5 mg\n* Analgesic/antipyretics: acetaminophen 16 mg, ibuprofen 10 mg\n* Steroids: prednisolone 1.5 mg, prednisone 0.5 mg\n* H2 receptor blockers: famotidine 4 mg, ranitidine 7.5 mg', 'armGroupLabels': ['Taste Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Bernard Lee, PharmD, RPh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Ole J Olson, Pharm.D., BCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Michelle J LoTurco, Pharm.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Bernard Lee', 'investigatorAffiliation': 'Mayo Clinic'}}}}