A Phase 3 interventional study of Naproxen Sodium ER (BAYH6689) in Pain, sponsored by Bayer. Completed at 34 sites in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-15.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Drug: Naproxen Sodium ER (BAYH6689)
BAYH6689; oral tablet used as needed upon incidence of pain
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
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
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
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
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
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
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
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
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
| Milestone | Patterns of Use Cohort | Reasons for Misuse Cohort |
|---|---|---|
| Started | 526 | 252 |
| Purchased product | 525 | 252 |
| Baseline assessment | 516 | 130 |
| Took product | 508 | 237 |
| Completed | 463 | 226 |
| Not completed | 63 | 26 |
| Withdrew: Lost to follow-up | 32 | 26 |
| Withdrew: Withdrawal by subject | 20 | 0 |
| Withdrew: Unable to complete full treatment period | 6 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Physician decision | 3 | 0 |
| Withdrew: Did not take product | 1 | 0 |
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.
| Percentage of Participants | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Estimated Percentage of Misuse for Non-Therapeutic Reasons | 6.5 |
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.
| Participants | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Non-therapeutic Reasons for Misuse | 52 |
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 | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course | 5 |
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 | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days | 14.9 |
Percentage of participants who took product with mean daily use \>/= 2 tablets /use day thus exceeding the label directions on any use day.
| Percentage of participants | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day | 4.8 |
Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.
| Percentage of participants | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken | 19.7 |
Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.
| Percentage of dosing occasions | Naproxen Sodium ER (BAYH6689) |
|---|---|
| Percentage of Dosing Occasions Where More Than One Tablet Was Taken | 5.4 |
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 participants | 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 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 dosing occasions | 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 |
Collected over 28 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | — | 6/745 (0.8%) | 89/745 (11.9%) |
| Event | Naproxen Sodium ER (BAYH6689) |
|---|---|
| overdoseInjury, poisoning and procedural complications | 1/745 |
| cardiac failure congestiveCardiac disorders | 1/745 |
| diarrhea haemorrhagicGastrointestinal disorders | 1/745 |
| viral infectionInfections and infestations | 1/745 |
| gallbladder disorderHepatobiliary disorders | 1/745 |
| hypersensitivityImmune system disorders | 1/745 |
| Event | Naproxen Sodium ER (BAYH6689) |
|---|---|
| nasopharyngitisInfections and infestations | 20/745 |
| abdominal pain upperGastrointestinal disorders | 14/745 |
| headacheNervous system disorders | 14/745 |
| constipationGastrointestinal disorders | 12/745 |
| diarrhoeaGastrointestinal disorders | 11/745 |
| sinusitisInfections and infestations | 10/745 |
| back painMusculoskeletal and connective tissue disorders | 8/745 |
| Age, Customized(Participants) | Patterns of Use User Population | Reasons for Misuse Interviewed Population | Total |
|---|---|---|---|
| 12 to 17 Years | 3 | 0 | 3 |
| 18 to 24 Years | 25 | 4 | 29 |
| 25 to 34 Years | 63 | 13 | 76 |
| 35 to 44 Years | 81 | 28 | 109 |
| 45 to 54 Years | 142 | 30 | 172 |
| 55 Years or Older | 202 | 55 | 257 |
| Sex: Female, Male(Participants) | Patterns of Use User Population | Reasons for Misuse Interviewed Population | Total |
|---|---|---|---|
| Female | 295 | 68 | 363 |
| Male | 221 | 62 | 283 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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