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OpenTrials
Completed

NCT Number: NCT02294019

Actual Use Trial of Ibuprofen 400 mg

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.

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Key information

Conditions

Patient Compliance Behavior Health Behavior Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Robert's Discount Pharmacy, Hoover, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 400 mg caplet

Drug

400 milligram (mg) caplet according to Drug Facts label

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2014
Registry last updated
May 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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