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Trial record 1 of 1 for:    NCT01789606
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Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

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ClinicalTrials.gov Identifier: NCT01789606
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 19, 2012
First Posted Date  ICMJE February 12, 2013
Results First Submitted Date  ICMJE July 24, 2017
Results First Posted Date  ICMJE August 28, 2017
Last Update Posted Date August 28, 2017
Actual Study Start Date  ICMJE September 24, 2012
Actual Primary Completion Date June 3, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication [ Time Frame: Day 1 ]
    Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (<) 6 hours, if left untreated.
  • Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity [ Time Frame: Day 1 ]
    Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of <6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain >=6 hours.
  • Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours [ Time Frame: Day 1 ]
    Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain <6 hours were reported in this outcome measure.
  • Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours [ Time Frame: Day 1 ]
    Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain >=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.
  • Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg [ Time Frame: Day 1 up to Day 30 ]
    Percentage of participants with the use of study medication for >10 days with an average daily dose of >1600 mg were reported in this outcome measure.
  • Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg [ Time Frame: Day 1 up to Day 30 ]
    Percentage of participants who used the study medication for <=10 days and used more than 20 tablets with an average daily dose of >1600 mg were reported in this outcome measure.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
  • Self-Selection Arm: Percentage of participants who either correctly select to use or correctly de-select not to use the 600 mg IR/ER product, based on typical duration of pain. [ Time Frame: 30 days ]
  • Compliance Arm: Percentage of participants who use the product for more than 10 days (not necessarily consecutive) during the study and have an average daily dose of greater than 1600 mg. [ Time Frame: 30 days ]
  • Compliance Arm: Percentage of participants who use the product for 10 days or less during the study, take more than 20 caplets and have an average daily dose of greater than 1600 mg. [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • Average Daily Dose Among Excessive Users [ Time Frame: Day 1 up to Day 30 ]
    Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of >1600 mg or all participants who used the study medication for <=10 days during study period, used more than 20 tablets and had an average daily dose of >1600 mg.
  • Number of Dosing Days Among Inappropriate Users [ Time Frame: Day 1 up to Day 30 ]
    Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, if left untreated, based on the information provided at the follow up interview.
  • Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users [ Time Frame: Day 1 up to Day 30 ]
    In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, based on the information provided at the follow up interview.
  • Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram [ Time Frame: Day 1 up to Day 30 ]
    Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.
  • Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms [ Time Frame: Day 1 up to Day 30 ]
    In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.
  • Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram [ Time Frame: Day 1 up to Day 30 ]
    In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.
  • Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms [ Time Frame: Day 1 up to Day 30 ]
    In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.
  • Average Daily Dose of Study Medication [ Time Frame: Day 1 up to Day 30 ]
  • Maximum Daily Dose of Study Medication [ Time Frame: Day 1 up to Day 30 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
  • Dosing patterns among subjects who use the product excessively. [ Time Frame: 30 days ]
  • Dosing patterns among subjects who are inappropriate self-selectors. [ Time Frame: 30 days ]
  • Dosing patterns related to exceeding 1200 mg/day. [ Time Frame: 30 days ]
  • Dosing paterns related to exceeding 600 mg/dose. [ Time Frame: 30 days ]
  • Average daily dose (within subject). [ Time Frame: 30 days ]
  • Maximum daily dose. [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
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 Date June 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 Committee No
U.S. FDA-regulated Product Not 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/data_requests

Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP