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Actual Use Trial of Ibuprofen 400 mg

Last updated on November 10, 2019

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Study Location
Robert's Discount Pharmacy
Hoover, Alabama, 35226 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Patient Compliance
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Current government-issued identification (ID)

- Pregnant or breastfeeding females

NCT02294019
Pfizer
Completed
Actual Use Trial of Ibuprofen 400 mg

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Descriptive Information
Brief Title  ICMJE Actual Use Trial of Ibuprofen 400 mg
Official Title  ICMJE A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment
Brief SummaryThis 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: None (Open Label)
Condition  ICMJE Patient Compliance
Intervention  ICMJE Drug: Ibuprofen 400 mg caplet
400 milligram (mg) caplet according to Drug Facts label
Study Arms  ICMJE Experimental: Ibuprofen caplet arm
Intervention: Drug: Ibuprofen 400 mg caplet
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2015)
738
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2014)
730
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion DateMay 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02294019
Other Study ID Numbers  ICMJE B3491013
AUT ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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