At a glance
ClinicalIndex Comparison Record- ✓Underwent oral surgery removing 2 unilateral third molar teeth
- ✓Pre-dose pain intensity ≥50 mm on 100 mm VAS within 5 hours of surgery
- ✓Pre-dose pain rated as moderate or severe within 5 hours of surgery
- ✕Any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic, or metabolic disorder
- ✕Analgesic or NSAID use within 5 half-lives of that drug prior to first dose (except surgical anesthesia)
- ✕Active dental infection at time of surgery
- ✕Recent (within 12 months) chronic analgesic or tranquilizer dependency history
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Double-dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-05089771 For The Treatment Of Postoperative Dental Pain Using Ibuprofen 400 Mg As Positive Control
In Brief
A Phase 2 clinical trial evaluating PF-05089771, Placebo, and 1 other intervention for Postoperative Dental Pain. Completed, enrolled 235 participants across 3 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively