Actual Use Trial of Ibuprofen 400 mg

Phase 3

Completed

• Conditions: Patient Compliance
• Interventions: Drug: Ibuprofen 400 mg caplet

• Registration Number: NCT02294019
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-04
• Results First Submitted: 2016-04-22
• Results First Submitted QC: 2016-04-22
• Last Update Submitted: 2016-04-22
• Results First Posted: 2016-05-30
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 738

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ibuprofen caplet arm	Ibuprofen 400 mg caplet	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study	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 Outcome Measures

Name	Time	Method
Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study	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.

Trial Locations

Locations (22)

Robert's Discount Pharmacy; 🇺🇸 Hoover, Alabama, United States

Pharmacy at the Pig; 🇺🇸 McCalla, Alabama, United States

Community Clinical Pharmacy; 🇺🇸 Mesa, Arizona, United States

Garden Drug; 🇺🇸 Fort Lauderdale, Florida, United States

Pill Box Pharmacy and Medical Supply; 🇺🇸 Pembroke Pines, Florida, United States

Summerfield Pharmacy; 🇺🇸 Riverview, Florida, United States

Sutton Family Pharmacy; 🇺🇸 Dalton, Georgia, United States

Wynn's Pharmacy Inc.; 🇺🇸 Griffin, Georgia, United States

Goodrich Pharmacy; 🇺🇸 Elk River, Minnesota, United States

Cub Pharmacy Number 1924; 🇺🇸 St. Louis Park, Minnesota, United States

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