Phase 2 N=235 Randomized Double-blind Treatment

Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

Postoperative Dental Pain

Bottom Line

View on ClinicalTrials.gov: NCT01529346 ↗

Enrolled (actual)

235

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) — 6.94; 6.21; 7.00; 14.43 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-05089771 (Drug); Placebo (Other); Ibuprofen (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Pain Relief From 0 to 6 Hours (TOTPAR[6])	6.94; 6.21; 7.00; 14.43; 4.37	—
SECONDARY Number of Participants With Peak Pain Relief (PPR)	13; 13; 15; 1; 9; 11	—
SECONDARY Pain Relief (PR) Score	0.55; 0.72; 0.65; 0.54; 0.63; 0.77	—
SECONDARY Pain Intensity Difference (PID)	0.12; 0.34; 0.21; 0.16; 0.14; 0.32	—
SECONDARY Summed Pain Intensity Difference (SPID)	2.52; 2.14; 2.79; 7.44; 0.45; 12.06	—
SECONDARY Total Pain Relief From 0 to 24 Hours (TOTPAR[24])	30.89; 22.81; 31.19; 51.18; 18.63	—
SECONDARY Time to Onset of First Perceptible Pain Relief	0.6; 0.3; 0.4; 0.5; 0.7	—
SECONDARY Time to Onset of Meaningful Pain Relief	3.3; 2.7; 3.7; 1.3; 4.6	—
SECONDARY Time to First Use of Rescue Medication	4.0; 2.5; 5.5; 12.1; 2.3	—
SECONDARY Number of Participants With Global Evaluation of Study Medication	2; 0; 3; 2; 0; 6	—
SECONDARY Number of Participants With Study Medication Satisfaction	5; 6; 12; 17; 0; 11	—
SECONDARY Plasma PF-05089771 Concentration	NA; NA; NA; 1383; 3497; 6718	—
SECONDARY Plasma Ibuprofen Concentration	0.0054; 5.510; 7.049; 9.042; 6.522; 2.574	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	22; 24; 28; 12; 16; 0	—
SECONDARY Number of Participants With Clinically Significant Laboratory Findings	0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Vital Signs	0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	0; 0; 0; 0; 0	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT01529346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.