Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005305-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) or Advil IR | Experimental | Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen sodium ER (BAYH6689) | Drug | Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
Not provided
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Only subjects who chose naproxen sodium were included in the analysis. | Posted | Number | Percentage of participants | up to 14 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen Sodium ER (BAY H6689) or Advil IR | Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Clinical and Medical Affairs | Bayer HealthCare LLC, Consumer Care | clinical-trials-contact@bayerhealthcare.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Advil | Drug | Commercially available Advil; oral caplet upon incidence of pain |
|
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 \ |
| Up to 14 days |
| Yorba Linda |
| California |
| 92886 |
| United States |
| Pembroke Pines | Florida | 33026 | United States |
| Griffin | Georgia | 30224 | United States |
| Andover | Minnesota | 55304 | United States |
| Roseville | Minnesota | 55113 | United States |
| Bountiful | Utah | 84010 | United States |
| West Jordan | Utah | 84088 | United States |
| Bellevue | Washington | 98007 | United States |
| Seattle | Washington | 98122 | United States |
| Years |
|
| Gender | 119 females; 115 males; 1 subject refused to provide gender information | Number | Participants |
|
Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium 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.
|
|
| 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 | Subgroup of Selection Evaluation Population | Posted | Number | Percentage of participants | Within 24 hours of their selection decision taken up to 14 days |
|
|
|
| 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 \ | Subgroup of Selection Evaluation Population: low literacy participants who had REALM score \ | Posted | Number | Percentage of participants | Up to 14 days |
|
|
|
| 0 |
| 237 |
| 14 |
| 237 |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain in extremity | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngtis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
Not provided