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Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Last updated on December 5, 2019

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Study Location
Medical Arts Rexall Pharmacy
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Analgesia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- at least 12 years of age

- use of at least 5 doses per month of over-the-counter pain relievers over the past 3
months

- provide written informed consent (subjects 12- assent and parent/guardian will provide written informed consent)

- capable of and willing to swallow the study medication

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

- participated in other research studies in the last 6 months

- they or someone else in their household work for a pharmaceutical company, is a
relative of study site personnel involved with the study, or an immediate family
member is already enrolled in the study

- have a history of known allergies to ibuprofen, aspirin, or other NSAIDs

- have a history of heart surgery in the last 60 days or planned heart surgery in the
next 60 days

- female subjects are pregnant or breast feeding

NCT01789606
Pfizer
Completed
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

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Descriptive Information
Brief Title  ICMJE Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
Official Title  ICMJE Ibuprofen 600 Mg Immediate Release/Extended Release (IR/ER) Caplet Self-selection, Safety And Compliance Study
Brief SummaryA self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Analgesia
Intervention  ICMJE Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Study Arms  ICMJE Experimental: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Intervention: Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Publications *Paluch E, Jayawardena S, Wilson B, Farnsworth S. Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet. J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):397-404. doi: 10.1016/j.japh.2016.03.003. Epub 2016 May 13.


*   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: July 24, 2017)
1083
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2013)
710
Actual Study Completion Date  ICMJE June 3, 2013
Actual Primary Completion DateJune 3, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • at least 12 years of age
  • use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months
  • provide written informed consent (subjects 12-<18 years of age provide a written assent and parent/guardian will provide written informed consent)
  • capable of and willing to swallow the study medication

Exclusion Criteria:

  • participated in other research studies in the last 6 months
  • they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study
  • have a history of known allergies to ibuprofen, aspirin, or other NSAIDs
  • have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days
  • female subjects are pregnant or breast feeding
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01789606
Other Study ID Numbers  ICMJE B4371008
AK-10-11 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...

Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2017

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

[email protected]

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