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The Impact of Generic Labels on Compliance

NCT ID: NCT01862406

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Generic Label Brand-name Label

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Generic Label

Purportedly generic version of the analgesic presented

Group Type EXPERIMENTAL

Label

Intervention Type OTHER

Participants were presented with either a generic label or a brand-name label

Brand-name Label

actual brand-name analgesic presented

Group Type ACTIVE_COMPARATOR

Label

Intervention Type OTHER

Participants were presented with either a generic label or a brand-name label

Interventions

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Label

Participants were presented with either a generic label or a brand-name label

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo dental implants and/or bone graft surgeries at the UFSC dental clinic

Exclusion Criteria

* Patients not scheduled to undergo these treatments
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Santa Catarina

OTHER

Sponsor Role lead

Responsible Party

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Marco Aurelio Bianchini

Associate Professor of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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UFSC-CEPSH-649-322600

Identifier Type: -

Identifier Source: org_study_id