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Trial record 1 of 1 for:    NCT00740857
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Study Comparing the Efficacy of Two Ibuprofen Formulations

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ClinicalTrials.gov Identifier: NCT00740857
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : August 12, 2010
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 22, 2008
First Posted Date  ICMJE August 25, 2008
Results First Submitted Date  ICMJE October 30, 2009
Results First Posted Date  ICMJE August 12, 2010
Last Update Posted Date June 6, 2011
Study Start Date  ICMJE August 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
Time to Meaningful Pain Relief [ Time Frame: 0-6 hours ]
Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
Time to Meaningful Pain Relief [ Time Frame: 6 hours ]
Change History Complete list of historical versions of study NCT00740857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • Pain Intensity Difference (PID) Scores at Each Individual Time Points [ Time Frame: 0-6 hours ]
    PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.
  • Pain Relief (PR) Scores at Individual Time Points [ Time Frame: 0-6 hours ]
    Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.
  • 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 ]
    SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).
  • Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points [ Time Frame: 0-6 hours ]
    PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).
  • Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]
    SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).
  • Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]
    TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)
  • Time to First Perceptible Relief [ Time Frame: 0-6 hours ]
    The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
PID (pain intensity difference), PR (pain relief), SPRID from 0-2 hours and 0-6 hours, PRID, SPID, TOTPAR. Time to first perceptible relief. [ Time Frame: 6 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing the Efficacy of Two Ibuprofen Formulations
Official Title  ICMJE A Study Comparing the Efficacy of Two Ibuprofen Formulations
Brief Summary This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: placebo
    2 placebo gels capsules delivered as a single dose.
  • Drug: ibuprofen Formulation 1
    2 marketed ibuprofen gels
  • Drug: ibuprofen Formulation 2
    2 marketed ibuprofen gels
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Active Comparator: 2
    Intervention: Drug: ibuprofen Formulation 1
  • Active Comparator: 3
    Intervention: Drug: ibuprofen Formulation 2
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: July 15, 2010)
211
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2008)
230
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Outpatients with post-operative pain following surgical extraction of third molars,
  • examined by the attending dentist or physician and medically cleared to participate in the study,
  • in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria:

  • any serious medical condition,
  • acute localized dental infection at the time of surgery ,
  • females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 40 Years   (Child, 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 NCT00740857
Other Study ID Numbers  ICMJE PV-08-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2011

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