Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
Status and phase
Completed
Phase 2
Conditions
Postoperative Dental Pain
Treatments
Other: Placebo
Drug: PF-05089771
Drug: Ibuprofen
Details and patient eligibility
About
The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.
Enrollment
235 patients
Sex
All
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Oral surgery having removed 2 unilateral third molar teeth.
- Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of oral surgery
- Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery
Exclusion criteria
- Presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results.
- Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
- Active dental infection at the time of surgery.
- Recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency.
- Any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement).
Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
235 participants in 5 patient groups, including a placebo group
PF-05089771 1600 mg
Experimental group
Treatment:
Drug: PF-05089771
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Drug: PF-05089771
Other: Placebo
Other: Placebo
Drug: PF-05089771
PF-05089771 450 mg
Experimental group
Treatment:
Drug: PF-05089771
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Drug: PF-05089771
Other: Placebo
Other: Placebo
Drug: PF-05089771
PF-05089771 150 mg
Experimental group
Treatment:
Drug: PF-05089771
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Drug: PF-05089771
Other: Placebo
Other: Placebo
Drug: PF-05089771
Ibuprofen 400 mg
Active Comparator group
Treatment:
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Drug: Ibuprofen
Placebo
Placebo Comparator group
Treatment:
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Other: Placebo
Trial contacts and locations
3
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Data sourced from clinicaltrials.gov
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