Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Pfizer

Status and phase

Completed

Phase 3

Conditions

Analgesia

Treatments

Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01789606

B4371008

AK-10-11 (Other Identifier)

Details and patient eligibility

About

A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.

Enrollment

1,083 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

at least 12 years of age
use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months
provide written informed consent (subjects 12-<18 years of age provide a written assent and parent/guardian will provide written informed consent)
capable of and willing to swallow the study medication

Exclusion criteria

participated in other research studies in the last 6 months
they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study
have a history of known allergies to ibuprofen, aspirin, or other NSAIDs
have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days
female subjects are pregnant or breast feeding