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Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

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ClinicalTrials.gov Identifier: NCT01559259
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 19, 2012
First Posted Date  ICMJE March 21, 2012
Last Update Posted Date July 30, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2012)
Time weighted sum of pain intensity difference scores and pain relief scores from 0-8 hours after dosing [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01559259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
  • Time to onset of "meaningful" relief [ Time Frame: 12 hours ]
  • Time to onset of "first perceptible" relief, confirmed by "meaningful" relief [ Time Frame: 12 hours ]
  • Pain relief rating scored on a 5-point categorical relief rating scale [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Pain intensity difference scored on a 4-point categorical pain severity rating scale [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post dose ]
  • Pain intensity difference scored on the 11-point numerical pain severity rating scale [ Time Frame: 0.25, 05, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Sum of pain relief rating and pain intensity difference score [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Time-weighted sum of pain intensity difference scores (categorical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time weighted sum of pain intensity difference score (numerical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time-weighted sum of pain relief scores [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time-weighted sum of pain relief rating scores combined with pain intensity difference scores (categorical scale) [ Time Frame: 2, 6 and 12 hours post dose ]
  • Cumulative proportion of subjects achieving "meaningful" relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Cumulative proportion of subjects achieving "first perceptible" relief comfirmed by "meaningful" relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Duration of relief, as measured by time to treatment failure [ Time Frame: 12 hours ]
  • Cumulative proportion of treatment failures [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Subject global evaluation of study medication [ Time Frame: 12 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2012)
  • Time to onset of "meaningful" relief [ Time Frame: 12 hours ]
  • Time to onset of "first perceptible" relief, confirmed by "meaningful" relief [ Time Frame: 12 hours ]
  • Pain relief rating scored on a 5-point categorical relief rating scale [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Pain intensity difference scored on a 4-point categorical pain severity rating scale [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post dose ]
  • Pain intensity difference scored on the 11-point numerical pain severity rating scale [ Time Frame: 0.25, 05, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Sum of pain relief rating and pain intensity difference score [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Time-weighted sum of pain intensity difference scores (categorical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time weighted sum of pain intensity difference score (numerical scale) [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time-weighted sum of pain relief scores [ Time Frame: 2, 6, 8 and 12 hours post dose ]
  • Time-weighted sum of pain relief rating scores combined with pain intensity difference scores (categorical scale) [ Time Frame: 2, 6 and 12 hours post dose ]
  • Cumulative proportion of subjects achieving "meaningful" relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Cumulative proportion of subjects achieving "first perceptible" relief confirmed by "meaningful" relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Duration of relief, as measured by time to treatment failure [ Time Frame: 12 hours ]
  • Cumulative proportion of treatment failures [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose ]
  • Subject global evaluation of study medication [ Time Frame: 12 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Official Title  ICMJE Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Brief Summary This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ibuprofen/acetaminophen
    Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
  • Drug: Ibuprofen/acetaminophen
    Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg
  • Drug: Ibuprofen/acetaminophen
    Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg
  • Drug: Ibuprofen
    Two caplets of ibuprofen 200 mg
  • Drug: Placebo
    Two caplets of placebo
Study Arms  ICMJE
  • Experimental: Ibuprofen/acetaminophen (lower dose)
    Intervention: Drug: Ibuprofen/acetaminophen
  • Experimental: Ibuprofen/acetaminophen (middle dose)
    Intervention: Drug: Ibuprofen/acetaminophen
  • Experimental: Ibuprofen/acetaminophen (high dose)
    Intervention: Drug: Ibuprofen/acetaminophen
  • Active Comparator: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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: September 19, 2012)
394
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2012)
410
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females 16 to 40 years of age
  • Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth

Exclusion Criteria:

  • Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
  • Pregnant or breastfeeding females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01559259
Other Study ID Numbers  ICMJE B5061001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 2014

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