The Impact of Generic Labels on Compliance

Not Applicable

Completed

• Conditions: Generic Label; Brand-name Label
• Interventions: Other: Label

• Registration Number: NCT01862406
• Lead Sponsor: Universidade Federal de Santa Catarina

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Generic Label	Label	Purportedly generic version of the analgesic presented
Brand-name Label	Label	actual brand-name analgesic presented

Primary Outcome Measures

Name	Time	Method
Non-Compliance	4 days after the intervention	Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 2 to day 4)
Non-compliance	7 days after the intervention	Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 5 to day 7)

Secondary Outcome Measures

Name	Time	Method
Consumption Dosage	4 days after the intervention	Average number of pills consumed during the study period (from day 2 to day 4)
Consumption dosage	7 days after the intervention	Average number of pills consumed during the study period (from day 5 to 7)