Pain
Conditions
Keywords
Self Selection Tria
Brief summary
A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.
Interventions
Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain
DRUGAdvil
Commercially available Advil; oral caplet upon incidence of pain
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 12 years of age * Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the past month * Able to read and understand English * Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent) * Provide contact information
Exclusion criteria
* Have participated in a trial involving OTC analgesics in the last 6 months * They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels) * Have a history of known allergies to Nonsteroidal Antiinflammatory Drugs (NSAIDs) (i.e., naproxen, ibuprofen, acetaminophen, aspirin, etc.) * Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days * Female subjects who have a positive urine pregnancy test or who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours | up to 14 days | Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours | Within 24 hours of their selection decision taken up to 14 days | — |
| The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours | Up to 14 days | In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score \</= 60 at visit 1. |
Countries
United States
Participant flow
Pre-assignment details
435 subjects were screened, 384 were qualified for participation, 259 subjects presented at pharmacy to begin enrollment procedures, 254 gave inform consent, 1 subject refused to give pregnancy test, so 253 subject received the investigational products.
Participants by arm
| Arm | Count |
|---|---|
| Naproxen Sodium ER (BAY H6689) or Advil IR Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages. | 235 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not take any product | 6 |
| Overall Study | Incomplete information for analysis | 2 |
| Overall Study | Lost to Follow-up | 10 |
Baseline characteristics
| Characteristic | Naproxen Sodium ER (BAY H6689) or Advil IR |
|---|---|
| Age, Continuous | 51.4 Years STANDARD_DEVIATION 14.3 |
| Gender Female | 119 Participants |
| Gender Male | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 237 |
| serious Total, serious adverse events | 0 / 237 |
Outcome results
Primary
The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).
Time frame: up to 14 days
Population: Only subjects who chose naproxen sodium were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAY H6689) or Advil IR | The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours | 72.0 Percentage of participants |
Secondary
The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score \</= 60 at visit 1.
Time frame: Up to 14 days
Population: Subgroup of Selection Evaluation Population: low literacy participants who had REALM score \</= 60 at visit 1 and chose naproxen sodium.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAY H6689) or Advil IR | The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours | 64.5 Percentage of participants |
Secondary
The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours
Time frame: Within 24 hours of their selection decision taken up to 14 days
Population: Subgroup of Selection Evaluation Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAY H6689) or Advil IR | The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours | 71.5 Percentage of participants |