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Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Austin, Texas, 78744 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post-surgical Dental Pain
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Oral surgical procedure having removed 2 third molars (unilateral).

- Pre-dose pain intensity score (100 mm Visual Analog Scale [VAS]) >50 mm within 5 hours
of oral surgery.

- Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.

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

- Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
neurological (including subjects with a history of frequent moderate to severe
headaches or subjects with episodic migraines more than twice per month), psychiatric,
gastrointestinal, pulmonary, hematologic, or metabolic disorder.

- Prior use of any type of analgesic or NSAID within five half-lives of that drug or
less before taking the first dose of study medication, except for anesthesia for the
procedure.

- Recent history of chronic analgesic or tranquilizer dependency.

- Active dental infection at the time of surgery.

- Any significant oral surgery complication at the time of surgery or in the immediate
postoperative period or dental surgery lasting > 30 minutes.

- Subjects who are smokers.

NCT01512160
Pfizer
Terminated
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

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Descriptive Information
Brief Title  ICMJE Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
Official Title  ICMJE A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control
Brief SummaryThe purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.
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 Post-surgical Dental Pain
Intervention  ICMJE
  • Drug: PF-04531083
    2000 mg oral solution
  • Other: Placebo
    Placebo tablets for Ibuprofen
  • Drug: PF-04531083
    1000 mg oral solution
  • Drug: Ibuprofen
    2 x 200 mg tablets
  • Other: Placebo
    Placebo solution for PF-04531083
Study Arms  ICMJE
  • Experimental: PF-04531083 2000 mg
    Interventions:
    • Drug: PF-04531083
    • Other: Placebo
  • Experimental: PF-04531083 1000 mg
    Interventions:
    • Drug: PF-04531083
    • Other: Placebo
  • Active Comparator: Ibuprofen 400 mg
    Interventions:
    • Drug: Ibuprofen
    • Other: Placebo
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Placebo
    • Other: 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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 10, 2012)
90
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2012)
140
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion DateMarch 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Oral surgical procedure having removed 2 third molars (unilateral).
  • Pre-dose pain intensity score (100 mm Visual Analog Scale [VAS]) >50 mm within 5 hours of oral surgery.
  • Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.

Exclusion Criteria:

  • Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.
  • Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
  • Recent history of chronic analgesic or tranquilizer dependency.
  • Active dental infection at the time of surgery.
  • Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting > 30 minutes.
  • Subjects who are smokers.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (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 NCT01512160
Other Study ID Numbers  ICMJE B1351010
Has Data Monitoring CommitteeYes
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 DateMay 2013

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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Contact

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