Clinical trial NCT01862406: The Impact of Generic Labels on Compliance
Official title: The Impact of Generic Labels on Consumption Dosage and Medication Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generic Label
Brand-name Label
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-Compliance
timeFrame: 1 day after the intervention
measure: Non-Compliance
timeFrame: 4 days after the intervention
measure: Non-compliance
timeFrame: 7 days after the intervention
Secondary outcomes:
measure: Consumption Dosage
timeFrame: 1 day after the intervention
measure: Consumption Dosage
timeFrame: 4 days after the intervention
measure: Consumption dosage
timeFrame: 7 days after the intervention
Other outcomes:
measure: Pain levels
timeFrame: 1 day after the intervention
measure: Pain levels
timeFrame: 4 days after the intervention
measure: Pain levels
timeFrame: 7 days after the intervention
measure: Perceived Efficacy
timeFrame: 1 day after the intervention
measure: Perceived Efficacy
timeFrame: 4 days after the intervention
measure: Perceived Efficacy
timeFrame: 7 days after the intervention
measure: Referral
timeFrame: 1 day after the intervention
measure: referral
timeFrame: 4 days after the intervention
measure: referral
timeFrame: 7 days after the intervention
Locations:
Study officials:
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