Actual Use Trial of Ibuprofen 400 mg

Pfizer738 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Masking

NONE

Enrollment

738

Conditions

Patient Compliance

Interventions

Ibuprofen 400 mg capletDRUG

400 milligram (mg) caplet according to Drug Facts label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

Robert's Discount Pharmacy

Hoover, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 1 up to 30 days

Secondary Outcomes

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.

Time frame: Day1 up to 30 days

Data from ClinicalTrials.gov

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