Clinical trial NCT02294019: Actual Use Trial of Ibuprofen 400 mg
Official title: A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patient Compliance
Keywords: ibuprofen 400 mg
actual use
compliance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-11-19
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Current government-issued identification (ID)
* Pregnant or breastfeeding females

Primary outcomes:
measure: Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study
timeFrame: Day 1 up to 30 days
Secondary outcomes:
measure: Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study
timeFrame: Day1 up to 30 days
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Robert's Discount Pharmacy
state: Alabama
city: McCalla
country: United States
facility: Pharmacy at the Pig
state: Alabama
city: Mesa
country: United States
facility: Community Clinical Pharmacy
state: Arizona
city: Fort Lauderdale
country: United States
facility: Garden Drug
state: Florida
city: Pembroke Pines
country: United States
facility: Pill Box Pharmacy and Medical Supply
state: Florida
city: Riverview
country: United States
facility: Summerfield Pharmacy
state: Florida
city: Dalton
country: United States
facility: Sutton Family Pharmacy
state: Georgia
city: Griffin
country: United States
facility: Wynn's Pharmacy Inc.
state: Georgia
city: Andover
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Anoka
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Blaine
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Elk River
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: St. Louis Park
country: United States
facility: Cub Pharmacy Number 1924
state: Minnesota
city: Kansas City
country: United States
facility: Albers' Specialty Pharmacy
state: Missouri
city: Savannah
country: United States
facility: Countryside Pharmacy
state: Missouri
city: Monroe
country: United States
facility: Texas Road Pharmacy
state: New Jersey
city: Albuquerque
country: United States
facility: Phil's Pills, Inc.
state: New Mexico
city: Taos
country: United States
facility: Total Health and Wellness Center of Taos
state: New Mexico
city: Cary
country: United States
facility: Kroger Pharmacy #342
state: North Carolina
city: Bethlehem
country: United States
facility: Family Prescription Center
state: Pennsylvania
city: Bountiful
country: United States
facility: The Medicine Shoppe
state: Utah
city: Layton
country: United States
facility: Northview Pharmacy
state: Utah
city: West Jordan
country: United States
facility: Family Plaza Pharmacy
state: Utah
city: Enumclaw
country: United States
facility: Foothills Compounding Pharmacy
state: Washington
city: Kenmore
country: United States
facility: Ostrom Drugs
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: