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

Pfizer1,083 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,083

Conditions

Analgesia

Interventions

Ibuprofen 600 mg Immediate Release/Extended Release CapletDRUG

Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (18)

Medical Arts Rexall Pharmacy

Anaheim, California, United States

B and B Pharmacy

Yorba Linda, California, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication

Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\<) 6 hours, if left untreated.

Time frame: Day 1

Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity

Time frame: Day 1

Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours

Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \<6 hours were reported in this outcome measure.

Time frame: Day 1

Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours

Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.

Time frame: Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Average Daily Dose Among Excessive Users

Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of \>1600 mg or all participants who used the study medication for \<=10 days during study period, used more than 20 tablets and had an average daily dose of \>1600 mg.