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

• Status: Completed
• Trial end date: 2013-06-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Ibuprofen

Criteria

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