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Completed

NCT Number: NCT01862406

The Impact of Generic Labels on Compliance

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.

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Key information

Conditions

Generic Label Brand-name Label

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Label

Other

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

Primary outcomes

  1. Non-Compliance

    Time frame: 1 day after the intervention

    Number of patients who consumed at least one non-prescribed analgesic pill during the first 24 hours

  2. Non-Compliance

    Time frame: 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)

  3. Non-compliance

    Time frame: 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 outcomes

  1. Consumption Dosage

    Time frame: 1 day after the intervention

    Average number of pills consumed during the study period (first 24 hours)

  2. Consumption Dosage

    Time frame: 4 days after the intervention

    Average number of pills consumed during the study period (from day 2 to day 4)

  3. Consumption dosage

    Time frame: 7 days after the intervention

    Average number of pills consumed during the study period (from day 5 to 7)

Other outcomes

  1. Pain levels

    Time frame: 1 day after the intervention

    Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)

  2. Pain levels

    Time frame: 4 days after the intervention

    Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)

  3. Pain levels

    Time frame: 7 days after the intervention

    Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)

  4. Perceived Efficacy

    Time frame: 1 day after the intervention

    perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)

  5. Perceived Efficacy

    Time frame: 4 days after the intervention

    perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)

  6. Perceived Efficacy

    Time frame: 7 days after the intervention

    perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)

  7. Referral

    Time frame: 1 day after the intervention

    the likelihood of indicating it a friend (0=Never; 10=Certainly).

  8. referral

    Time frame: 4 days after the intervention

    the likelihood of indicating it a friend (0=Never; 10=Certainly).

  9. referral

    Time frame: 7 days after the intervention

    the likelihood of indicating it a friend (0=Never; 10=Certainly).

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Catarina

Other

Registry information

Official study title

The Impact of Generic Labels on Consumption Dosage and Medication Compliance

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 24, 2013
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.