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| ID | Type | Description | Link |
|---|---|---|---|
| AUT | Other Identifier | Alias Study Number |
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This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen caplet arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 400 mg caplet | Drug | 400 milligram (mg) caplet according to Drug Facts label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview. | Day 1 up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert's Discount Pharmacy | Hoover | Alabama | 35226 | United States | ||
| Pharmacy at the Pig |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants were screened by phone,then referred to their participating retail pharmacy site for scheduled face-to-face interview,after which they were given an empty ibuprofen 400 milligram (mg) caplet over-the-counter (OTC) package to review information on outside of entire package,then decision was made to purchase medicine by them.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | All participants who purchased at least 1 carton of study medication. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Day1 up to 30 days |
| McCalla |
| Alabama |
| 35111 |
| United States |
| Community Clinical Pharmacy | Mesa | Arizona | 85202 | United States |
| Garden Drug | Fort Lauderdale | Florida | 33309 | United States |
| Pill Box Pharmacy and Medical Supply | Pembroke Pines | Florida | 33026 | United States |
| Summerfield Pharmacy | Riverview | Florida | 33569 | United States |
| Sutton Family Pharmacy | Dalton | Georgia | 30721 | United States |
| Wynn's Pharmacy Inc. | Griffin | Georgia | 30224 | United States |
| Goodrich Pharmacy | Andover | Minnesota | 55304 | United States |
| Goodrich Pharmacy | Anoka | Minnesota | 55303 | United States |
| Goodrich Pharmacy | Blaine | Minnesota | 55434 | United States |
| Goodrich Pharmacy | Elk River | Minnesota | 55330 | United States |
| Cub Pharmacy Number 1924 | Saint Louis Park | Minnesota | 55426 | United States |
| Albers' Specialty Pharmacy | Kansas City | Missouri | 64111 | United States |
| Countryside Pharmacy | Savannah | Missouri | 64485 | United States |
| Texas Road Pharmacy | Monroe | New Jersey | 08831 | United States |
| Phil's Pills, Inc. | Albuquerque | New Mexico | 87110 | United States |
| Total Health and Wellness Center of Taos | Taos | New Mexico | 87571 | United States |
| Kroger Pharmacy #342 | Cary | North Carolina | 27513 | United States |
| Family Prescription Center | Bethlehem | Pennsylvania | 18015 | United States |
| The Medicine Shoppe | Bountiful | Utah | 84010 | United States |
| Northview Pharmacy | Layton | Utah | 84041 | United States |
| Family Plaza Pharmacy | West Jordan | Utah | 84088 | United States |
| Foothills Compounding Pharmacy | Enumclaw | Washington | 98022 | United States |
| Ostrom Drugs | Kenmore | Washington | 98028 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All participants who purchased at least 1 carton of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | All participants who purchased at least 1 carton of study medication. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview. | Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to 30 days |
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| Secondary | Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview. | Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary. | Posted | Number | 95% Confidence Interval | percentage of participants | Day1 up to 30 days |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
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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 | Ibuprofen (Safety Population) | Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study | 6 | 736 | 76 | 736 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery occlusion | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Sialoadenitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Eye injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Anger | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Renal pain | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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