NCT01862406

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

2.2 years

First QC Date

May 16, 2013

Last Update Submit

August 7, 2013

Conditions

Generic LabelBrand-name Label

Outcome Measures

Primary Outcomes (3)

  • Non-Compliance

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

    1 day after the intervention

  • Non-Compliance

    Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 2 to day 4)

    4 days after the intervention

  • Non-compliance

    Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 5 to day 7)

    7 days after the intervention

Secondary Outcomes (3)

  • Consumption Dosage

    1 day after the intervention

  • Consumption Dosage

    4 days after the intervention

  • Consumption dosage

    7 days after the intervention

Other Outcomes (9)

  • Pain levels

    1 day after the intervention

  • Pain levels

    4 days after the intervention

  • Pain levels

    7 days after the intervention

  • +6 more other outcomes

Study Arms (2)

Generic Label

EXPERIMENTAL

Purportedly generic version of the analgesic presented

Other: Label

Brand-name Label

ACTIVE COMPARATOR

actual brand-name analgesic presented

Other: Label

Interventions

LabelOTHER

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

Brand-name LabelGeneric Label

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients not scheduled to undergo these treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Drug Labeling

Intervention Hierarchy (Ancestors)

Technology, PharmaceuticalInvestigative TechniquesDrug PackagingDrug IndustryManufacturing IndustryIndustryTechnology, Industry, and AgricultureProduct Packaging

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Dentistry

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 24, 2013

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 9, 2013

Record last verified: 2013-08