Study Comparing the Efficacy of Two Ibuprofen Formulations

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00740857
First received: August 22, 2008
Last updated: June 1, 2011
Last verified: June 2011
Results First Received: October 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: placebo
Drug: ibuprofen Formulation 1
Drug: ibuprofen Formulation 2

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in the United States from August 2008 to October 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the screening period, the Investigator or his/her designee examined each subject and completed a checklist of the inclusion/exclusion criteria in order to determine the patient’s eligibility. Surgery occurred within 14 days of the screening visit.

Reporting Groups
  Description
Placebo 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
Ibuprofen Formulation 1 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
Ibuprofen Formulation 2 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery

Participant Flow:   Overall Study
    Placebo     Ibuprofen Formulation 1     Ibuprofen Formulation 2  
STARTED     33     88     90  
COMPLETED     32     88     90  
NOT COMPLETED     1     0     0  
Withdrawal by Subject                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
Ibuprofen Formulation 1 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
Ibuprofen Formulation 2 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
Total Total of all reporting groups

Baseline Measures
    Placebo     Ibuprofen Formulation 1     Ibuprofen Formulation 2     Total  
Number of Participants  
[units: participants]
  33     88     90     211  
Age  
[units: years]
Mean ± Standard Deviation
  18.8  ± 2.7     18.5  ± 2.5     19.0  ± 3.0     18.8  ± 2.7  
Gender  
[units: participants]
       
Female     16     43     45     104  
Male     17     45     45     107  



  Outcome Measures
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1.  Primary:   Time to Meaningful Pain Relief   [ Time Frame: 0-6 hours ]

2.  Secondary:   Pain Intensity Difference (PID) Scores at Each Individual Time Points   [ Time Frame: 0-6 hours ]

3.  Secondary:   Pain Relief (PR) Scores at Individual Time Points   [ Time Frame: 0-6 hours ]

4.  Secondary:   Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours   [ Time Frame: 0-2 and 0-6 hours ]

5.  Secondary:   Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points   [ Time Frame: 0-6 hours ]

6.  Secondary:   Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours   [ Time Frame: 0-2 and 0-6 hours ]

7.  Secondary:   Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours   [ Time Frame: 0-2 and 0-6 hours ]

8.  Secondary:   Time to First Perceptible Relief   [ Time Frame: 0-6 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00740857     History of Changes
Other Study ID Numbers: PV-08-24
Study First Received: August 22, 2008
Results First Received: October 30, 2009
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board