Clinical trial NCT01789606: Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
Official title: Ibuprofen 600 Mg Immediate Release/Extended Release (IR/ER) Caplet Self-selection, Safety And Compliance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Keywords: Self-selection and actual use/compliance trial.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 1083
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg
timeFrame: Day 1 up to Day 30
measure: Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg
timeFrame: Day 1 up to Day 30
Secondary outcomes:
measure: Average Daily Dose Among Excessive Users
timeFrame: Day 1 up to Day 30
measure: Number of Dosing Days Among Inappropriate Users
timeFrame: Day 1 up to Day 30
measure: Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users
timeFrame: Day 1 up to Day 30
measure: Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram
timeFrame: Day 1 up to Day 30
measure: Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms
timeFrame: Day 1 up to Day 30
measure: Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram
timeFrame: Day 1 up to Day 30
measure: Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms
timeFrame: Day 1 up to Day 30
measure: Average Daily Dose of Study Medication
timeFrame: Day 1 up to Day 30
measure: Maximum Daily Dose of Study Medication
timeFrame: Day 1 up to Day 30
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Medical Arts Rexall Pharmacy
state: California
city: Yorba Linda
country: United States
facility: B and B Pharmacy
state: California
city: Griffin
country: United States
facility: Wynn's Pharmacy Inc.
state: Georgia
city: Overland Park
country: United States
facility: Stark Pharmacy
state: Kansas
city: Baltimore
country: United States
facility: Catonsville Pharmacy
state: Maryland
city: Blaine
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Elk River
country: United States
facility: Kemper Drug
state: Minnesota
city: Saint Louis Park
country: United States
facility: Cub Pharmacy Number 1924
state: Minnesota
city: Kansas City
country: United States
facility: Albers' Medical Pharmacy
state: Missouri
city: Savannah
country: United States
facility: Countryside Pharmacy
state: Missouri
city: Albuquerque
country: United States
facility: Duran Central Pharmacy
state: New Mexico
city: Taos
country: United States
facility: Total Health and Wellness Center of Taos
state: New Mexico
city: Ogden
country: United States
facility: The Medicine Shoppe
state: Utah
city: Salt Lake City
country: United States
facility: The Medicine Shoppe
state: Utah
city: West Jordan
country: United States
facility: Family Plaza Pharmacy
state: Utah
city: Montpelier
country: United States
facility: Montpelier Pharmacy, Inc.
state: Virginia
city: Kenmore
country: United States
facility: Ostrom Drugs
state: Washington
city: Snohomish
country: United States
facility: Kusler's Pharmacy
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Paluch E, Jayawardena S, Wilson B, Farnsworth S. Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet. J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):397-404. doi: 10.1016/j.japh.2016.03.003. Epub 2016 May 13.