Pain
Conditions
Keywords
Actual Use Trial
Brief summary
An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.
Interventions
BAYH6689; oral tablet used as needed upon incidence of pain
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
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 OTC analgesics for pain on at least 5 days in the last month * Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it * 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 * Purchase the investigational product
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 NSAIDs (i.e., naproxen, ibuprofen, 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) are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Percentage of Misuse for Non-Therapeutic Reasons | 28 days | The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course | 28 days | This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by use day. A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive evaluable days. |
| Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days | 28 days | Percentage of participants took \>/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course. |
| Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day | 28 days | Percentage of participants who took product with mean daily use \>/= 2 tablets /use day thus exceeding the label directions on any use day. |
| Non-therapeutic Reasons for Misuse | 28 days | Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse. |
| Percentage of Dosing Occasions Where More Than One Tablet Was Taken | 28 days | Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions. |
| Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose | 28 days | Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection. |
| Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose | 28 days | Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection |
| Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken | 28 days | Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patterns of Use User Population A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use. | 516 |
| Reasons for Misuse Interviewed Population A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions \[took more than one tablet per dose or a subsequent dose less than 22 hours later\]), and completed the reasons for misuse questions. | 130 |
| Total | 646 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not take product | 1 | 0 |
| Overall Study | Lost to Follow-up | 32 | 26 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Unable to complete full treatment period | 6 | 0 |
| Overall Study | Withdrawal by Subject | 20 | 0 |
Baseline characteristics
| Characteristic | Patterns of Use User Population | Reasons for Misuse Interviewed Population | Total |
|---|---|---|---|
| Age, Customized 12 to 17 Years | 3 Participants | 0 Participants | 3 Participants |
| Age, Customized 18 to 24 Years | 25 Participants | 4 Participants | 29 Participants |
| Age, Customized 25 to 34 Years | 63 Participants | 13 Participants | 76 Participants |
| Age, Customized 35 to 44 Years | 81 Participants | 28 Participants | 109 Participants |
| Age, Customized 45 to 54 Years | 142 Participants | 30 Participants | 172 Participants |
| Age, Customized 55 Years or Older | 202 Participants | 55 Participants | 257 Participants |
| Sex: Female, Male Female | 295 Participants | 68 Participants | 363 Participants |
| Sex: Female, Male Male | 221 Participants | 62 Participants | 283 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 89 / 745 |
| serious Total, serious adverse events | 6 / 745 |
Outcome results
Primary
Estimated Percentage of Misuse for Non-Therapeutic Reasons
The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.
Time frame: 28 days
Population: Participants in Patterns of Use cohort who took the product + Participants in Reason for Misuse cohort who completed interview
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Estimated Percentage of Misuse for Non-Therapeutic Reasons | 6.5 Percentage of Participants |
Secondary
Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by use day. A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive evaluable days.
Time frame: 28 days
Population: Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course | 5 Percentage of participants |
Secondary
Non-therapeutic Reasons for Misuse
Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.
Time frame: 28 days
Population: Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Non-therapeutic Reasons for Misuse | 52 Participants |
Secondary
Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection
Time frame: 28 days
Population: Participants in Patterns of Use cohort who took the product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose | 27.8 Percentage of dosing occasions |
Secondary
Percentage of Dosing Occasions Where More Than One Tablet Was Taken
Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.
Time frame: 28 days
Population: Participants in Patterns of Use cohort who took the product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Percentage of Dosing Occasions Where More Than One Tablet Was Taken | 5.4 Percentage of dosing occasions |
Secondary
Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days
Percentage of participants took \>/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.
Time frame: 28 days
Population: Participants in Patterns of Use User Population who had at least 10 use days of the product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days | 14.9 Percentage of participants |
Secondary
Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.
Time frame: 28 days
Population: Participants in Patterns of Use cohort who took the product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose | 72.5 Percentage of participants |
Secondary
Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day
Percentage of participants who took product with mean daily use \>/= 2 tablets /use day thus exceeding the label directions on any use day.
Time frame: 28 days
Population: Participants in Patterns of Use User Population who had at least 10 use days of the product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day | 4.8 Percentage of participants |
Secondary
Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken
Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.
Time frame: 28 days
Population: Participants in Patterns of Use cohort who took the product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken | 19.7 Percentage of participants |