Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study:
1. Male or female 18 years of age or older, has history of using oral OTC analgesics at
OTC dose levels, defined as taking at least 5 doses/month on average during the past 3
months, and qualifies for inclusion in at least one risk group category, including
cardiovascular, gastrointestinal bleeding, history of severe pain (≥5 episodes in last
month) or >65 years of age (see Groups 1 4 in Section 3.1).
OR Male or female 12-17 years of age and has history of using oral OTC analgesics at
OTC dose levels, defined as taking at least 5 doses/month on average during the past 3
months.
2. Evidence of a personally signed and dated informed consent document (ICD), and in the
case of minor adolescent subjects (12-17 years of age or adolescent subjects residing
in states where the age of majority is > than 18), an assent document, indicating that
the subject and where applicable a legally acceptable representative/parent(s)/legal
guardian has been informed of all pertinent aspects of the study.
3. Willing and able to comply with scheduled visits, treatment plan, and other study
procedures.
4. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and
able to purchase study medication.
5. Agrees the product purchased is for subject's own use and not to be shared.
6. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and
able to provide contact information for follow up purposes.
Subjects with any of the following characteristics/conditions will not be included in the
study:
1. Subject (or parent/guardian, if applicable) cannot read, speak, and/or understand
English.
2. Trained or employed as a healthcare professional.
3. Subject or someone else in the household is employed by a pharmaceutical company,
medical practice or hospital, pharmacy, managed care or health insurance organization
or a contract research organization.
4. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
potential subjects who are Pfizer employees, including their family members, directly
involved in the conduct of the study.
5. Participation in other studies involving investigational drug(s) within 6 months prior
to study entry and/or during study participation.
6. Known hypersensitivity to ibuprofen, aspirin, or any other NSAIDs.
7. Subjects with the following clinical conditions which place them at excessively high
risk or have ?20% 10 year risk for atherosclerotic cardiovascular disease (ASCVD), as
defined by the 2013 ACC/AHA Guidelines on the Assessment of Atherosclerotic
Cardiovascular Risk, will not be included in the study: clinically established
coronary heart disease; cerebrovascular disease; peripheral artery disease; abdominal
aortic aneurysm; and chronic kidney disease. Subjects who have experienced a prior non
fatal cardiovascular disease event (angina, heart failure, heart disease, heart
attack, stroke/transient ischemic attack) or have had heart surgery or who currently
have uncontrolled high blood pressure (either by self report or by measured systolic
blood pressure higher than 180 mmHg or diastolic pressure higher than 120 mmHg at the
time of the enrollment interview), will also be excluded from the study.
8. Subjects with concurrent or recent (within 30 days) use of anticoagulants, a prior
history of complicated peptic ulcer, or a gastrointestinal bleeding event requiring
hospitalization or blood transfusion.
9. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product (IP)
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
10. Pregnant female subjects; breastfeeding female subjects; and male and female subjects
of childbearing potential who are unwilling or unable to use a highly effective method
of contraception as outlined in this protocol for the duration of the study and for 28
days after the end of their 30-Day Use Phase or, for subjects who use the
investigational product after Day 30, 28 days after the last recorded dose of
investigational product.
11. 18 years of age or older and classified as normal literacy (REALM Test score ?61)
after the normal literacy group quotas (approximately 70% of adult subjects) are full
or refuses to complete the REALM Test (note there is no corresponding literacy
exclusion criterion for adolescent subjects based on REALM Teen score).
12. 18 years of age or older and classified as moderate (less frequent) oral OTC pain
reliever user (
moderate user group quotas (approximately 33% of adult subjects) are full.
13. Not capable of swallowing a vitamin sized tablet.
14. Refuses to participate in required assessments (such as urine pregnancy, finger stick
cholesterol or blood pressure tests, or unable or unwilling to comply with electronic
diary procedures).
The following additional exclusion criteria will be applied for adolescent subjects
only (12-17 years of age):
15. Has developmental or learning disabilities that, in the judgment of the
parent/guardian or the investigator, would interfere with study participation.
16. Another adolescent child from the family is already enrolled into the study, or
parent/guardian does not agree that only one adolescent child from the family or
household will be enrolled into the study.