Actual Use Trial of Ibuprofen 400 mg

NCT ID: NCT02294019

Last Updated: 2016-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

738 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Patient Compliance

Keywords

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ibuprofen 400 mg actual use compliance

Study Design

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Blinding Strategy

NONE

Study Groups

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Ibuprofen caplet arm

Group Type EXPERIMENTAL

Ibuprofen 400 mg caplet

Intervention Type DRUG

400 milligram (mg) caplet according to Drug Facts label

Interventions

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Ibuprofen 400 mg caplet

400 milligram (mg) caplet according to Drug Facts label

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Robert's Discount Pharmacy

Hoover, Alabama, United States

Site Status

Pharmacy at the Pig

McCalla, Alabama, United States

Site Status

Community Clinical Pharmacy

Mesa, Arizona, United States

Site Status

Garden Drug

Fort Lauderdale, Florida, United States

Site Status

Pill Box Pharmacy and Medical Supply

Pembroke Pines, Florida, United States

Site Status

Summerfield Pharmacy

Riverview, Florida, United States

Site Status

Sutton Family Pharmacy

Dalton, Georgia, United States

Site Status

Wynn's Pharmacy Inc.

Griffin, Georgia, United States

Site Status

Goodrich Pharmacy

Andover, Minnesota, United States

Site Status

Goodrich Pharmacy

Anoka, Minnesota, United States

Site Status

Goodrich Pharmacy

Blaine, Minnesota, United States

Site Status

Goodrich Pharmacy

Elk River, Minnesota, United States

Site Status

Cub Pharmacy Number 1924

Saint Louis Park, Minnesota, United States

Site Status

Albers' Specialty Pharmacy

Kansas City, Missouri, United States

Site Status

Countryside Pharmacy

Savannah, Missouri, United States

Site Status

Texas Road Pharmacy

Monroe, New Jersey, United States

Site Status

Phil's Pills, Inc.

Albuquerque, New Mexico, United States

Site Status

Total Health and Wellness Center of Taos

Taos, New Mexico, United States

Site Status

Kroger Pharmacy #342

Cary, North Carolina, United States

Site Status

Family Prescription Center

Bethlehem, Pennsylvania, United States

Site Status

The Medicine Shoppe

Bountiful, Utah, United States

Site Status

Northview Pharmacy

Layton, Utah, United States

Site Status

Family Plaza Pharmacy

West Jordan, Utah, United States

Site Status

Foothills Compounding Pharmacy

Enumclaw, Washington, United States

Site Status

Ostrom Drugs

Kenmore, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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AUT

Identifier Type: OTHER

Identifier Source: secondary_id

B3491013

Identifier Type: -

Identifier Source: org_study_id