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

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Ibuprofen

Criteria

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.