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

Last updated on May 10, 2018

FOR MORE INFORMATION
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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Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
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
The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Post-surgical Dental Pain
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
May 2012
March 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01512160
B1351010
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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