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

Ibuprofen 600 Mg Immediate Release/Extended Release (IR/ER) Caplet Self-selection, Safety And Compliance Study

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 Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet

• Study Type: Interventional
• Enrollment (Actual): 1083
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Medical Arts Rexall Pharmacy
    • Yorba Linda, California, United States, 92886
      • B and B Pharmacy
  • Georgia
    • Griffin, Georgia, United States, 30224
      • Wynn's Pharmacy Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Stark Pharmacy
  • Maryland
    • Baltimore, Maryland, United States, 21228
      • Catonsville Pharmacy
  • Minnesota
    • Blaine, Minnesota, United States, 55434
      • Goodrich Pharmacy
    • Elk River, Minnesota, United States, 55330
      • Kemper Drug
    • Saint Louis Park, Minnesota, United States, 55426
      • Cub Pharmacy Number 1924
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Albers' Medical Pharmacy
    • Savannah, Missouri, United States, 64485
      • Countryside Pharmacy
  • New Mexico
    • Albuquerque, New Mexico, United States, 87104
      • Duran Central Pharmacy
    • Taos, New Mexico, United States, 87571
      • Total Health and Wellness Center of Taos
  • Utah
    • Ogden, Utah, United States, 84401
      • The Medicine Shoppe
    • Salt Lake City, Utah, United States, 84121
      • The Medicine Shoppe
    • West Jordan, Utah, United States, 84088
      • Family Plaza Pharmacy
  • Virginia
    • Montpelier, Virginia, United States, 23192
      • Montpelier Pharmacy, Inc.
  • Washington
    • Kenmore, Washington, United States, 98028
      • Ostrom Drugs
    • Snohomish, Washington, United States, 98290
      • Kusler's Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen 600 mg Immediate Release/Extended Release Caplet	Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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 <6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain >=6 hours.	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.	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.	Day 1
Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg	Percentage of participants with the use of study medication for >10 days with an average daily dose of >1600 mg were reported in this outcome measure.	Day 1 up to Day 30
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	Percentage of participants who used the study medication for <=10 days and used more than 20 tablets with an average daily dose of >1600 mg were reported in this outcome measure.	Day 1 up to Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 up to Day 30
Number of Dosing Days Among Inappropriate Users	Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, if left untreated, based on the information provided at the follow up interview.	Day 1 up to Day 30
Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users	In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, based on the information provided at the follow up interview.	Day 1 up to Day 30
Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram	Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.	Day 1 up to Day 30
Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms	In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.	Day 1 up to Day 30
Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram	In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.	Day 1 up to Day 30
Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms	In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.	Day 1 up to Day 30
Average Daily Dose of Study Medication		Day 1 up to Day 30
Maximum Daily Dose of Study Medication		Day 1 up to Day 30

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2012
• Primary Completion (Actual): June 3, 2013
• Study Completion (Actual): June 3, 2013

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Self-selection and actual use/compliance trial.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: B4371008; AK-10-11 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests