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

August 22, 2008
June 1, 2011
August 2008
November 2008   (final data collection date for primary outcome measure)
Time to Meaningful Pain Relief [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
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.
Time to meaningful pain relief [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00740857 on ClinicalTrials.gov Archive Site
  • Pain Intensity Difference (PID) Scores at Each Individual Time Points [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Comparing the Efficacy of Two Ibuprofen Formulations
A Study Comparing the Efficacy of Two Ibuprofen Formulations

This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pain
  • 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
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Active Comparator: 2
    Intervention: Drug: ibuprofen Formulation 1
  • Active Comparator: 3
    Intervention: Drug: ibuprofen Formulation 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
16 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00740857
PV-08-24
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2011

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