PainPhase 3NCT00751400
Naproxen Sodium Extended-Release Actual Use Study
A Phase 3 study testing Naproxen Sodium ER (BAYH6689) in people with Pain, run by Bayer at 24 sites in United States.
Trial summary
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Naproxen Sodium ER (BAYH6689)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 24 sitesUnited States
- Study dates
- Jul 2008to Nov 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Study site
Anaheim, California, 92801
Study site
Anoka, Minnesota, 55303
Study site
Belton, Missouri, 64012
Study site
Blaine, Minnesota, 55443
Study site
Bountiful, Utah, 84010
Study site
Cary, North Carolina, 27513
Study site
Chapel Hill, North Carolina, 27514
Study site
Elk River, Minnesota, 55330
Study site
Kenmore, Washington, 98028
Study site
Oceanside, California, 92054
Study site
Ogden, Utah, 84401
Study site
Overland Park, Kansas, 66209
Study site
Raleigh, North Carolina, 27606
Study site
Raleigh, North Carolina, 27612
Study site
Saint Francis, Minnesota, 55070
Study site
Saint Joseph, Missouri, 64504
Study site
Saint Louis Park, Minnesota, 55426
Study site
Salt Lake City, Utah, 84102
Study site
San Dimas, California, 91773
Study site
Savannah, Missouri, 64485
Study site
Seattle, Washington, 98148
Study site
Snohomish, Washington, 98290
Study site
Syracuse, Utah, 84075
Study site
West Jordan, Utah, 84088
About this study
Official title: An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Read the 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)
- Conditions
- Pain
- Being tested
- Naproxen Sodium ER (BAYH6689)
- Keywords
- Non-prescription
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen Sodium ER (BAYH6689)Drug
Consumer use of Extended Release Naproxen Sodium
| Study group | Role | What they receive |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Experimental | 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 Receives: Drug: Naproxen Sodium ER (BAYH6689) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (9)
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.
Measured: 1 month
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.
Measured: 1 month
Number of Subjects With and Without More Than One Tablet Taken Per Dose
Measured: 1 month
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.
Measured: 1 month
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).
Measured: 1 month
Average Daily Dose
Measured: 1 month
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
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pegus Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751400
- Sponsor's protocol ID
- 13129
- Other IDs
- 2014-005268-13, 2014
- Status last verified
- Aug 2015
- First submitted
- 11 Sep 2008
- Last updated
- 25 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting
- ClinicalTrials.gov ID
- NCT00751400
- Acronym / sponsor ID
- 13129
- Conditions
- Pain
- Keywords
- Non-prescription
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Pegus Research, Inc.
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Posted 17 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Experimental | Drug: 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Naproxen Sodium ER (BAYH6689)Consumer use of Extended Release Naproxen Sodium | Drug | Naproxen Sodium ER (BAYH6689) |
Primary outcome
Use Days With One or More Misuse Occasions
Time frame: 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.
9 secondary outcomes
Dosing Occasions With One and More Than One Tablet Taken
Time frame: 1 month
Use Days With and Without Next Dose Less Than 22 Hours Later
Time frame: 1 month
Number of Subjects With and Without More Than One Tablet Taken Per Dose
Time frame: 1 month
Number of Subjects With and Without Next Dose Less Than 22 Hours Later
Time frame: 1 month
Number of Subjects With and Without More Than 660 mg at Least Once
Time frame: 1 month
Average Daily Dose
Time frame: 1 month
Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days
Time frame: 1 month
Number of Total Dosing Occasions Per Subject
Time frame: 1 month
Number of Dosing Occasions Per Subject That Exceeded 660 mg
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naproxen Sodium ER (BAYH6689) in people with Pain, run by Bayer at 24 sites in United States.
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 4 inclusion and 5 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 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Use Days With One or More Misuse Occasions (time frame: 1 month). 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 25 Aug 2015.