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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Post-surgical Dental Pain

In brief

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.

Key facts

Study ID

NCT01512160

Run by

Pfizer

People needed

90

Starts

2011-10-01

Expected to finish

2012-05-01

Last updated by the study team

2013-06-28

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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