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

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Salt Lake City, Utah, 84124 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence of history of significant hepatic, renal, endocrine, cardiovascular,
neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic
disorder

- Pregnant or breastfeeding females

NCT01559259
Pfizer
Completed
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

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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 SummaryThis study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
Detailed DescriptionNot 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 DateSeptember 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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