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

Last updated on March 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.
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- 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.
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- 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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