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

Last updated on December 17, 2017

FOR MORE INFORMATION
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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Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
Ibuprofen 600 Mg Immediate Release/Extended Release (IR/ER) Caplet Self-selection, Safety And Compliance Study
A 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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Analgesia
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.
Experimental: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Intervention: Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1083
June 3, 2013
June 3, 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01789606
B4371008
AK-10-11 ( Other Identifier: Alias Study Number )
No
Not Provided
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...

URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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