Actual Use Trial of Ibuprofen 400 mg

NCT02294019 | Completed Phase 3 Results

• 2 other identifiers: B3491013AUT
• Study Type: interventional
• Target: 738
• Locations: 1 country
• Sites: 25

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.

Conditions

Patient Compliance

Keywords

ibuprofen 400 mg; actual use; compliance

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study

  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 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

  Day1 up to 30 days

Study Arms (1)

Ibuprofen caplet arm

EXPERIMENTAL

Drug: Ibuprofen 400 mg caplet

Interventions

Ibuprofen 400 mg caplet DRUG

400 milligram (mg) caplet according to Drug Facts label

Ibuprofen caplet arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Robert's Discount Pharmacy

Hoover, Alabama, 35226, United States

Location

Pharmacy at the Pig

McCalla, Alabama, 35111, United States

Location

Community Clinical Pharmacy

Mesa, Arizona, 85202, United States

Location

Garden Drug

Fort Lauderdale, Florida, 33309, United States

Location

Pill Box Pharmacy and Medical Supply

Pembroke Pines, Florida, 33026, United States

Location

Summerfield Pharmacy

Riverview, Florida, 33569, United States

Location

Sutton Family Pharmacy

Dalton, Georgia, 30721, United States

Location

Wynn's Pharmacy Inc.

Griffin, Georgia, 30224, United States

Location

Goodrich Pharmacy

Andover, Minnesota, 55304, United States

Location

Goodrich Pharmacy

Anoka, Minnesota, 55303, United States

Location

Goodrich Pharmacy

Blaine, Minnesota, 55434, United States

Location

Goodrich Pharmacy

Elk River, Minnesota, 55330, United States

Location

Cub Pharmacy Number 1924

Saint Louis Park, Minnesota, 55426, United States

Location

Albers' Specialty Pharmacy

Kansas City, Missouri, 64111, United States

Location

Countryside Pharmacy

Savannah, Missouri, 64485, United States

Location

Texas Road Pharmacy

Monroe, New Jersey, 08831, United States

Location

Phil's Pills, Inc.

Albuquerque, New Mexico, 87110, United States

Location

Total Health and Wellness Center of Taos

Taos, New Mexico, 87571, United States

Location

Kroger Pharmacy #342

Cary, North Carolina, 27513, United States

Location

Family Prescription Center

Bethlehem, Pennsylvania, 18015, United States

Location

The Medicine Shoppe

Bountiful, Utah, 84010, United States

Location

Northview Pharmacy

Layton, Utah, 84041, United States

Location

Family Plaza Pharmacy

West Jordan, Utah, 84088, United States

Location

Foothills Compounding Pharmacy

Enumclaw, Washington, 98022, United States

Location

Ostrom Drugs

Kenmore, Washington, 98028, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Patient Compliance

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 30, 2016
• Results First Posted: May 30, 2016

Record last verified: 2016-04

Locations

US (25)