Actual Use Trial of Ibuprofen 400 mg

Pfizer

Status and phase: Completed; Phase 3

Conditions: Patient Compliance

Treatments: Drug: Ibuprofen 400 mg caplet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02294019

B3491013

AUT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 738 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

738 participants in 1 patient group

Ibuprofen caplet arm

Experimental group

Treatment:

Drug: Ibuprofen 400 mg caplet