Generic LabelNCT01862406
The Impact of Generic Labels on Compliance
A study testing Label in people with Generic Label and Brand-name Label, run by Universidade Federal de Santa Catarina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Generic Label, Brand-name Label
- What is being tested?
- Label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo dental implants and/or bone graft surgeries at the UFSC dental clinic
Who cannot join
- Patients not scheduled to undergo these treatments
About this study
Official title: The Impact of Generic Labels on Consumption Dosage and Medication 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.
Read the 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.
- Conditions
- Generic Label, Brand-name Label
- Being tested
- Label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabelOther
Participants were presented with either a generic label or a brand-name label
| Study group | Role | What they receive |
|---|---|---|
| Generic Label | Experimental | Purportedly generic version of the analgesic presented Receives: Other: Label |
| Brand-name Label | Active comparator | actual brand-name analgesic presented Receives: Other: Label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Compliance
Number of patients who consumed at least one non-prescribed analgesic pill during the first 24 hours
Measured: 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)
Measured: 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)
Measured: 7 days after the intervention
Secondary outcomes (3)
Consumption Dosage
Average number of pills consumed during the study period (first 24 hours)
Measured: 1 day after the intervention
Consumption Dosage
Average number of pills consumed during the study period (from day 2 to day 4)
Measured: 4 days after the intervention
Consumption dosage
Average number of pills consumed during the study period (from day 5 to 7)
Measured: 7 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generic LabelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Aurelio Bianchini, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862406
- Sponsor's protocol ID
- UFSC-CEPSH-649-322600
- Status last verified
- Aug 2013
- First submitted
- 16 May 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Generic Labels on Consumption Dosage and Medication Compliance
- ClinicalTrials.gov ID
- NCT01862406
- Acronym / sponsor ID
- UFSC-CEPSH-649-322600
- Conditions
- Generic Label, Brand-name Label
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic Label | Experimental | Other: LabelPurportedly generic version of the analgesic presented |
| Brand-name Label | Active comparator | Other: Labelactual brand-name analgesic presented |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo dental implants and/or bone graft surgeries at the UFSC dental clinic
Key exclusion criteria (1 listed)
- Patients not scheduled to undergo these treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LabelParticipants were presented with either a generic label or a brand-name label | Other | Brand-name Label, Generic Label |
Primary outcome
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
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)
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)
3 secondary outcomes
Consumption Dosage
Time frame: 1 day after the intervention
Consumption Dosage
Time frame: 4 days after the intervention
Consumption dosage
Time frame: 7 days after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Label in people with Generic Label and Brand-name Label, run by Universidade Federal de Santa Catarina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Compliance (time frame: 1 day after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.