Pain
Conditions
Keywords
Non-prescription
Brief summary
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Detailed description
Issues on adverse event data are addressed in the Adverse Event section. The following acronyms and abbreviations were used in the results section. \- General Educational Development (GED)
Interventions
Consumer use of Extended Release Naproxen Sodium
Sponsors
Pegus Research, Inc.
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self report use of Over The Counter (OTC) analgesics * Able to read and understand English * Provide written informed consent (subjects 12- 17 years of age provide written as sent and/ or parent or legal guardian provide written consent) * Purchase the investigational product
Exclusion criteria
* Have participated in a study involving OTC analgesics in the last 12 months * They or someone else in the household work for a market research company, an advertising agency, a public relations firm, pharmaceutical company, as a healthcare professional, or as part of a health care practice * Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e., Naproxen, Ibuprofen, etc) or Aspirin * 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 |
|---|---|---|
| Use Days With One or More Misuse Occasions | 1 month | Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use Days With and Without Next Dose Less Than 22 Hours Later | 1 month | Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data. |
| Number of Subjects With and Without More Than One Tablet Taken Per Dose | 1 month | — |
| Number of Subjects With and Without Next Dose Less Than 22 Hours Later | 1 month | This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved. |
| Number of Subjects With and Without More Than 660 mg at Least Once | 1 month | This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion). |
| Dosing Occasions With One and More Than One Tablet Taken | 1 month | Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. |
| Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days | 1 month | This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing |
| Number of Total Dosing Occasions Per Subject | 1 month | Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. |
| Number of Dosing Occasions Per Subject That Exceeded 660 mg | 1 month | Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. |
| Average Daily Dose | 1 month | — |
Countries
United States
Participant flow
Recruitment details
Recruitment for the study was conducted using newspaper ads, direct mailing, in-store pharmacy posters, and flyers. Potential subjects who learned about the study through local advertising were directed to call a toll-free number (call center at the CRO (Contract Research Organization)) where minimal screening questions were asked.
Pre-assignment details
Once at the pharmacy, if the screening criteria were met, subjects were given an (empty) OTC (Over The Counter) package and were allowed as much time as needed to review the label. They were then told the cost of the investigational product and asked if they would like to purchase it for their own use.
Participants by arm
| Arm | Count |
|---|---|
| Naproxen Sodium ER (BAYH6689) subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever | 497 |
| Total | 497 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
Baseline characteristics
| Characteristic | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 15.1 |
| Education 8th grade or less | 6 participants |
| Education College graduate | 117 participants |
| Education High school graduate, GED, or certificate | 119 participants |
| Education Missing | 0 participants |
| Education Post-graduate degree | 49 participants |
| Education Some college or technical school | 185 participants |
| Education Some high school | 21 participants |
| Literacy Low | 56 participants |
| Literacy No REALM Score | 4 participants |
| Literacy Normal | 437 participants |
| Prior Analgesic Use Heavy | 148 participants |
| Prior Analgesic Use Regular | 349 participants |
| Race Asian | 8 participants |
| Race Black | 56 participants |
| Race Hispanic | 3 participants |
| Race Missing | 0 participants |
| Race Other | 31 participants |
| Race White | 399 participants |
| Sex: Female, Male Female | 292 Participants |
| Sex: Female, Male Male | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 111 / 485 |
| serious Total, serious adverse events | 3 / 485 |
Outcome results
Primary
Use Days With One or More Misuse Occasions
Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Use Days With One or More Misuse Occasions | use days without a misuse occasion | 2112 days |
| Naproxen Sodium ER (BAYH6689) | Use Days With One or More Misuse Occasions | use days with a misuse occasion | 294 days |
Secondary
Average Daily Dose
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Average Daily Dose | 722 mg | Standard Deviation 233.4 |
Secondary
Dosing Occasions With One and More Than One Tablet Taken
Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Dosing Occasions With One and More Than One Tablet Taken | only one tablet taken | 2500 dosing occasions |
| Naproxen Sodium ER (BAYH6689) | Dosing Occasions With One and More Than One Tablet Taken | more than one tablet taken | 66 dosing occasions |
Secondary
Number of Dosing Occasions Per Subject That Exceeded 660 mg
Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Number of Dosing Occasions Per Subject That Exceeded 660 mg | 0.6 dosing occasions | Standard Deviation 1.6 |
Secondary
Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days
This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing
Time frame: 1 month
Population: number of subjects reporting at least one tablet taken at any point during study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days | not more than 10 consecutive days | 376 participants |
| Naproxen Sodium ER (BAYH6689) | Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days | more than 10 consecutive days | 109 participants |
Secondary
Number of Subjects With and Without More Than 660 mg at Least Once
This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Number of Subjects With and Without More Than 660 mg at Least Once | not more than 660 mg | 344 participants |
| Naproxen Sodium ER (BAYH6689) | Number of Subjects With and Without More Than 660 mg at Least Once | more than 660 mg at least once | 123 participants |
Secondary
Number of Subjects With and Without More Than One Tablet Taken Per Dose
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Number of Subjects With and Without More Than One Tablet Taken Per Dose | never took more than one tablet per dose | 440 participants |
| Naproxen Sodium ER (BAYH6689) | Number of Subjects With and Without More Than One Tablet Taken Per Dose | took more than one tablet per dose | 27 participants |
Secondary
Number of Subjects With and Without Next Dose Less Than 22 Hours Later
This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Number of Subjects With and Without Next Dose Less Than 22 Hours Later | no doses less than 22 hours later | 359 participants |
| Naproxen Sodium ER (BAYH6689) | Number of Subjects With and Without Next Dose Less Than 22 Hours Later | at least one dose less than 22 hours later | 108 participants |
Secondary
Number of Total Dosing Occasions Per Subject
Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Number of Total Dosing Occasions Per Subject | 5.5 dosing occasions | Standard Deviation 3.7 |
Secondary
Use Days With and Without Next Dose Less Than 22 Hours Later
Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
Time frame: 1 month
Population: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Use Days With and Without Next Dose Less Than 22 Hours Later | no dose less than 22 hours later | 2175 days |
| Naproxen Sodium ER (BAYH6689) | Use Days With and Without Next Dose Less Than 22 Hours Later | at least one dose less than 22 hours later | 231 days |