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Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

Last updated on November 21, 2019

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Study Location
Central Texas Oral Surgery Associates
Austin, Texas, 78705 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postoperative Dental Pain
Sex
Females and Males
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 surgery having removed 2 unilateral third molar teeth.

- Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of
oral surgery

- Pre-dose pain intensity score of moderate or severe 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 known history of any clinically significant hematological, hepatic, renal,
endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary,
allergic (including known drug hypersensitivities or allergies, but excluding
untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase
risk associated with study participation, investigational drug administration or may
interfere with interpretation of study results.

- Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less
before taking the first dose of study medication, except for anesthesia for the
procedure.

- Active dental infection at the time of surgery.

- Recent (within the previous 12 months) history of chronic analgesic or tranquiliser
dependency.

- Any significant oral surgery complication at the time of surgery or in the immediate
postoperative period, or oral surgery that has lasted more than 30 minutes (time from
first incision to last suture placement).

Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or
use smokeless tobacco on a daily basis are excluded from the study.

NCT01529346
Pfizer
Completed
Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

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Descriptive Information
Brief Title  ICMJE Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
Official Title  ICMJE A Randomized, Double-blind, Double-dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-05089771 For The Treatment Of Postoperative Dental Pain Using Ibuprofen 400 Mg As Positive Control
Brief SummaryThe objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 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 Postoperative Dental Pain
Intervention  ICMJE
  • Drug: PF-05089771
    A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
  • Drug: PF-05089771
    A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
  • Drug: PF-05089771
    A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
  • Drug: Ibuprofen
    2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Study Arms  ICMJE
  • Experimental: PF-05089771 1600 mg
    Interventions:
    • Drug: PF-05089771
    • Other: Placebo
  • Experimental: PF-05089771 450 mg
    Interventions:
    • Drug: PF-05089771
    • Other: Placebo
  • Experimental: PF-05089771 150 mg
    Interventions:
    • Drug: PF-05089771
    • 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 Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2012)
235
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
234
Actual Study Completion Date  ICMJE June 25, 2012
Actual Primary Completion DateJune 25, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Oral surgery having removed 2 unilateral third molar teeth.
  • Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of oral surgery
  • Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery

Exclusion Criteria:

  • Presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results.
  • Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
  • Active dental infection at the time of surgery.
  • Recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency.
  • Any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement).

Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 NCT01529346
Other Study ID Numbers  ICMJE B3291009
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 DateMay 2018

ICMJE     Data element required by the

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

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