Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT01862406
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Generic Labels on Compliance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004348', 'term': 'Drug Labeling'}], 'ancestors': [{'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004349', 'term': 'Drug Packaging'}, {'id': 'D004345', 'term': 'Drug Industry'}, {'id': 'D066192', 'term': 'Manufacturing Industry'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D019064', 'term': 'Product Packaging'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-21', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain levels', 'timeFrame': '1 day after the intervention', 'description': 'Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)'}, {'measure': 'Pain levels', 'timeFrame': '4 days after the intervention', 'description': 'Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)'}, {'measure': 'Pain levels', 'timeFrame': '7 days after the intervention', 'description': 'Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)'}, {'measure': 'Perceived Efficacy', 'timeFrame': '1 day after the intervention', 'description': 'perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)'}, {'measure': 'Perceived Efficacy', 'timeFrame': '4 days after the intervention', 'description': 'perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)'}, {'measure': 'Perceived Efficacy', 'timeFrame': '7 days after the intervention', 'description': 'perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)'}, {'measure': 'Referral', 'timeFrame': '1 day after the intervention', 'description': 'the likelihood of indicating it a friend (0=Never; 10=Certainly).'}, {'measure': 'referral', 'timeFrame': '4 days after the intervention', 'description': 'the likelihood of indicating it a friend (0=Never; 10=Certainly).'}, {'measure': 'referral', 'timeFrame': '7 days after the intervention', 'description': 'the likelihood of indicating it a friend (0=Never; 10=Certainly).'}], 'primaryOutcomes': [{'measure': 'Non-Compliance', 'timeFrame': '1 day after the intervention', 'description': 'Number of patients who consumed at least one non-prescribed analgesic pill during the first 24 hours'}, {'measure': 'Non-Compliance', 'timeFrame': '4 days after the intervention', 'description': 'Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 2 to day 4)'}, {'measure': 'Non-compliance', 'timeFrame': '7 days after the intervention', 'description': 'Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 5 to day 7)'}], 'secondaryOutcomes': [{'measure': 'Consumption Dosage', 'timeFrame': '1 day after the intervention', 'description': 'Average number of pills consumed during the study period (first 24 hours)'}, {'measure': 'Consumption Dosage', 'timeFrame': '4 days after the intervention', 'description': 'Average number of pills consumed during the study period (from day 2 to day 4)'}, {'measure': 'Consumption dosage', 'timeFrame': '7 days after the intervention', 'description': 'Average number of pills consumed during the study period (from day 5 to 7)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Generic Label', 'Brand-name Label']}, 'descriptionModule': {'briefSummary': "Although generic drugs are pharmacologically equivalent to their brand-name counterparts, prejudices against the former remain strong among patients and doctors. In a randomized controlled field experiment, this research assesses the extent to which generic (versus brand-name) labels affect patients' consumption dosage, medication compliance and reported pain.", 'detailedDescription': 'One hundred one patients scheduled to undergo invasive dental surgeries (i.e., dental implants) participated in the experiment. After dental surgery, patients were prescribed a once-daily analgesic regimen for up to 7 days. The intervention consisted of label manipulation. Patients were randomly assigned to either the brand-name analgesic or to its (purportedly) cheaper generic version. In reality, all participants obtained the same brand-name medication. The medication was provided at no cost, and patients were instructed to take the first pill while at the clinic. They were informed that they could (a) increase the dosage of the prescribed analgesic to twice daily if necessary and (b) stop taking the medication when no longer needed. Any other changes to the regimen were discouraged, and patients were instructed to consult with the dentist before any such changes. Telephone follow-ups were conducted at 24 hours, 4 days, and 7 days after surgery. Two main dependent variables were obtained: the number of prescribed analgesics consumed and the number of non-prescribed analgesics consumed. The patients also reported the pain felt during the period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo dental implants and/or bone graft surgeries at the UFSC dental clinic\n\nExclusion Criteria:\n\n* Patients not scheduled to undergo these treatments'}, 'identificationModule': {'nctId': 'NCT01862406', 'briefTitle': 'The Impact of Generic Labels on Compliance', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Santa Catarina'}, 'officialTitle': 'The Impact of Generic Labels on Consumption Dosage and Medication Compliance', 'orgStudyIdInfo': {'id': 'UFSC-CEPSH-649-322600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Generic Label', 'description': 'Purportedly generic version of the analgesic presented', 'interventionNames': ['Other: Label']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brand-name Label', 'description': 'actual brand-name analgesic presented', 'interventionNames': ['Other: Label']}], 'interventions': [{'name': 'Label', 'type': 'OTHER', 'description': 'Participants were presented with either a generic label or a brand-name label', 'armGroupLabels': ['Brand-name Label', 'Generic Label']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Santa Catarina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Dentistry', 'investigatorFullName': 'Marco Aurelio Bianchini', 'investigatorAffiliation': 'Universidade Federal de Santa Catarina'}}}}