Actual Use Trial of Ibuprofen 400 mg

April 22, 2016 updated by: Pfizer

A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment

This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

738

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35226
        • Robert's Discount Pharmacy
      • McCalla, Alabama, United States, 35111
        • Pharmacy at the Pig
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Community Clinical Pharmacy
    • Florida
      • Fort Lauderdale, Florida, United States, 33309
        • Garden Drug
      • Pembroke Pines, Florida, United States, 33026
        • Pill Box Pharmacy and Medical Supply
      • Riverview, Florida, United States, 33569
        • Summerfield Pharmacy
    • Georgia
      • Dalton, Georgia, United States, 30721
        • Sutton Family Pharmacy
      • Griffin, Georgia, United States, 30224
        • Wynn's Pharmacy Inc.
    • Minnesota
      • Andover, Minnesota, United States, 55304
        • Goodrich Pharmacy
      • Anoka, Minnesota, United States, 55303
        • Goodrich Pharmacy
      • Blaine, Minnesota, United States, 55434
        • Goodrich Pharmacy
      • Elk River, Minnesota, United States, 55330
        • Goodrich Pharmacy
      • St. Louis Park, Minnesota, United States, 55426
        • Cub Pharmacy Number 1924
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Albers' Specialty Pharmacy
      • Savannah, Missouri, United States, 64485
        • Countryside Pharmacy
    • New Jersey
      • Monroe, New Jersey, United States, 08831
        • Texas Road Pharmacy
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Phil's Pills, Inc.
      • Taos, New Mexico, United States, 87571
        • Total Health and Wellness Center of Taos
    • North Carolina
      • Cary, North Carolina, United States, 27513
        • Kroger Pharmacy #342
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Family Prescription Center
    • Utah
      • Bountiful, Utah, United States, 84010
        • The Medicine Shoppe
      • Layton, Utah, United States, 84041
        • Northview Pharmacy
      • West Jordan, Utah, United States, 84088
        • Family Plaza Pharmacy
    • Washington
      • Enumclaw, Washington, United States, 98022
        • Foothills Compounding Pharmacy
      • Kenmore, Washington, United States, 98028
        • Ostrom Drugs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female at least 18 years of age (19 years of age in Alabama)
  • Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief

Exclusion Criteria:

  • Current government-issued identification (ID)
  • Pregnant or breastfeeding females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen caplet arm
Drug: Ibuprofen 400 mg caplet
400 milligram (mg) caplet according to Drug Facts label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study
Time Frame: Day 1 up to 30 days
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.
Day 1 up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study
Time Frame: Day1 up to 30 days
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview.
Day1 up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3491013
  • AUT (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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