Actual Use Trial of Ibuprofen 400 mg
- Registration Number
- NCT02294019
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 738
- Male or female at least 18 years of age (19 years of age in Alabama)
- Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief
- Current government-issued identification (ID)
- Pregnant or breastfeeding females
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ibuprofen caplet arm Ibuprofen 400 mg caplet -
- Primary Outcome Measures
Name Time Method Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study Day 1 up to 30 days 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study Day1 up to 30 days 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.
Trial Locations
- Locations (22)
Community Clinical Pharmacy
🇺🇸Mesa, Arizona, United States
Family Plaza Pharmacy
🇺🇸West Jordan, Utah, United States
Robert's Discount Pharmacy
🇺🇸Hoover, Alabama, United States
Pharmacy at the Pig
🇺🇸McCalla, Alabama, United States
Garden Drug
🇺🇸Fort Lauderdale, Florida, United States
Sutton Family Pharmacy
🇺🇸Dalton, Georgia, United States
Pill Box Pharmacy and Medical Supply
🇺🇸Pembroke Pines, Florida, United States
Wynn's Pharmacy Inc.
🇺🇸Griffin, Georgia, United States
Summerfield Pharmacy
🇺🇸Riverview, Florida, United States
Goodrich Pharmacy
🇺🇸Elk River, Minnesota, United States
Cub Pharmacy Number 1924
🇺🇸St. Louis Park, Minnesota, United States
Countryside Pharmacy
🇺🇸Savannah, Missouri, United States
Albers' Specialty Pharmacy
🇺🇸Kansas City, Missouri, United States
Texas Road Pharmacy
🇺🇸Monroe, New Jersey, United States
Phil's Pills, Inc.
🇺🇸Albuquerque, New Mexico, United States
Total Health and Wellness Center of Taos
🇺🇸Taos, New Mexico, United States
Kroger Pharmacy #342
🇺🇸Cary, North Carolina, United States
Family Prescription Center
🇺🇸Bethlehem, Pennsylvania, United States
Foothills Compounding Pharmacy
🇺🇸Enumclaw, Washington, United States
The Medicine Shoppe
🇺🇸Bountiful, Utah, United States
Northview Pharmacy
🇺🇸Layton, Utah, United States
Ostrom Drugs
🇺🇸Kenmore, Washington, United States