Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
Condition: Pain
Intervention: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Intervention description: Ibuprofen 600 mg Immediate Release/Extended Release Tablet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Parallel Assignment
Intervention model description: The Actual Use Trial (AUT) design utilizes a real world setting to assess the ability of consumers to use an investigational product that will be marketed in an over-the-counter setting according to the proposed product labelling. The primary objective of this AUT is to evaluate compliance with the labeled dosing directions for Advil 12 Hour and to understand why misuse occurred and if it was a conscious decision by the subject. A secondary objective is to evaluate the safety of Advil 12 Hour in unsupervised actual use and how it relates to misuse.
Masking: None (Open Label)
Enrollment: 613.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk)
      adult and adolescent consumers designed to mimic an OTC-like environment. More specifically,
      "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (>65 years of
      age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular
      (CV) adverse events, consumers who experience severe pain, low literacy subjects, and
      adolescents (12-17 years of age). The total number of subjects expected to enroll into the
      study is approximately 820. Sites will be pharmacies in diverse geographic locations around
      the US. Prospective adult subjects will be recruited via general population and targeted risk
      condition advertising (although participants will not be informed as to specific health
      conditions for which they are being recruited), while adolescents will be recruited using
      targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of
      prospective adolescent subjects) responding to the advertisements or recruitment calls will
      be initially screened by telephone, and eligibility will subsequently be verified in-person
      at the pharmacy site.
    

Eligibility criteria:

        Inclusion Criteria

        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.

        Exclusion Criteria

        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 (<30 doses per month on average in the preceding 3 months) after the
             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.