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The Impact of Generic Labels on Compliance

The Impact of Generic Labels on Consumption Dosage and Medication Compliance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01862406
Enrollment
101
Registered
2013-05-24
Start date
2010-10-31
Completion date
2012-12-31
Last updated
2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brand-name Label, Generic Label

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.

Interventions

OTHERLabel

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

Sponsors

Universidade Federal de Santa Catarina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Non-Compliance1 day after the interventionNumber of patients who consumed at least one non-prescribed analgesic pill during the first 24 hours
Non-compliance7 days after the interventionNumber of patients who consumed at least one non-prescribed analgesic pill during the period (from day 5 to day 7)

Secondary

MeasureTime frameDescription
Consumption Dosage1 day after the interventionAverage number of pills consumed during the study period (first 24 hours)
Consumption dosage7 days after the interventionAverage number of pills consumed during the study period (from day 5 to 7)

Other

MeasureTime frameDescription
Pain levels1 day after the interventionAverage retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)
Perceived Efficacy1 day after the interventionperceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)
Referral1 day after the interventionthe likelihood of indicating it a friend (0=Never; 10=Certainly).
referral4 days after the interventionthe likelihood of indicating it a friend (0=Never; 10=Certainly).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026