Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
Status and phase
Terminated
Phase 2
Conditions
Post-surgical Dental Pain
Treatments
Drug: Ibuprofen
Other: Placebo
Drug: PF-04531083
Details and patient eligibility
About
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.
Enrollment
90 patients
Sex
Male
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
90 participants in 4 patient groups, including a placebo group
PF-04531083 2000 mg
Experimental group
Treatment:
Other: Placebo
Drug: PF-04531083
Drug: PF-04531083
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
PF-04531083 1000 mg
Experimental group
Treatment:
Other: Placebo
Drug: PF-04531083
Drug: PF-04531083
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Ibuprofen 400 mg
Active Comparator group
Treatment:
Other: Placebo
Drug: Ibuprofen
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Placebo
Placebo Comparator group
Treatment:
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems