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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005268-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Pegus Research, Inc. | INDUSTRY |
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The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Drug | Consumer use of Extended Release Naproxen Sodium |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 1 month |
| 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 | 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. | 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). | 1 month |
| Average Daily Dose | 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 | 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. | 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. | 1 month |
| Oceanside |
| California |
| 92054 |
| United States |
| San Dimas | California | 91773 | United States |
| Overland Park | Kansas | 66209 | United States |
| Anoka | Minnesota | 55303 | United States |
| Blaine | Minnesota | 55443 | United States |
| Elk River | Minnesota | 55330 | United States |
| Saint Francis | Minnesota | 55070 | United States |
| Saint Louis Park | Minnesota | 55426 | United States |
| Belton | Missouri | 64012 | United States |
| Saint Joseph | Missouri | 64504 | United States |
| Savannah | Missouri | 64485 | United States |
| Cary | North Carolina | 27513 | United States |
| Chapel Hill | North Carolina | 27514 | United States |
| Raleigh | North Carolina | 27606 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Bountiful | Utah | 84010 | United States |
| Ogden | Utah | 84401 | United States |
| Salt Lake City | Utah | 84102 | United States |
| Syracuse | Utah | 84075 | United States |
| West Jordan | Utah | 84088 | United States |
| Kenmore | Washington | 98028 | United States |
| Seattle | Washington | 98148 | United States |
| Snohomish | Washington | 98290 | United States |
| Subjects Provided Drug |
|
| Subjects Consumed Drug |
|
| Subjects Provided Detailed Use Data |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Education | Number | participants |
| |||||||||||||||||||||||
| Literacy | Rapid Estimate of Adult Literacy in Medicine (REALM) scores range from 0-66 (single scale): a score of 61 or greater is considered normal literacy; a score of 60 or less is considered low literacy. | Number | participants |
| ||||||||||||||||||||||
| Prior Analgesic Use | Heavy analgesic user: 30 or more doses of Over The Counter (OTC) analgesics per month (self reported based on categorical responses). Regular analgesic user: 5 to 29 doses of OTC analgesics per month (self reported based on categorical responses). | Number | participants |
| ||||||||||||||||||||||
| Race | Number | participants |
|
| 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 | 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. | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Number | days | 1 month |
|
|
| |||||||||||||||||||||||||||||||||
| 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. | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Number | dosing occasions | 1 month |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Number | days | 1 month |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With and Without More Than One Tablet Taken Per Dose | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Number | participants | 1 month |
|
| |||||||||||||||||||||||||||||||||||
| 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. | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Number | participants | 1 month |
|
| ||||||||||||||||||||||||||||||||||
| 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). | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Number | participants | 1 month |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Average Daily Dose | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Mean | Standard Deviation | mg | 1 month |
|
| ||||||||||||||||||||||||||||||||||
| 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 | number of subjects reporting at least one tablet taken at any point during study | Posted | Number | participants | 1 month |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Mean | Standard Deviation | dosing occasions | 1 month |
|
| |||||||||||||||||||||||||||||||||
| 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. | Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days | Posted | Mean | Standard Deviation | dosing occasions | 1 month |
|
|
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| 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 (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 | 3 | 485 | 111 | 485 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dental discomfort | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sluggishness | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Gingival infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Feeding tube complication | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
No control group, detailed data collected for up to 10 days during 1 month followup, data recall by subjects may vary
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| High school graduate, GED, or certificate |
|
| Some college or technical school |
|
| College graduate |
|
| Post-graduate degree |
|
| Missing |
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| No REALM Score |
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| Hispanic |
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| Asian |
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| Other |
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| Missing |
|
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| never took more than one tablet per dose |
| |||||
| took more than one tablet per dose |
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| Title | Denominators | Categories |
|---|
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