Clinical trial NCT01529346: Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Dental Pain
Keywords: Postoperative dental pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Total Pain Relief From 0 to 6 Hours (TOTPAR[6])
timeFrame: 0 to 6 hours
Secondary outcomes:
measure: Number of Participants With Peak Pain Relief (PPR)
timeFrame: 0 to 24 hours
measure: Pain Relief (PR) Score
timeFrame: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
measure: Pain Intensity Difference (PID)
timeFrame: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
measure: Summed Pain Intensity Difference (SPID)
timeFrame: 0 to 6 hours; 0 to 24 hours
measure: Total Pain Relief From 0 to 24 Hours (TOTPAR[24])
timeFrame: 0 to 24 hours
measure: Time to Onset of First Perceptible Pain Relief
timeFrame: 0 to 24 hours
measure: Time to Onset of Meaningful Pain Relief
timeFrame: 0 to 24 hours
measure: Time to First Use of Rescue Medication
timeFrame: 0 to 24 hours
measure: Number of Participants With Global Evaluation of Study Medication
timeFrame: 6, 24 hours, prior to rescue medication (assessed up to 24 hours)
measure: Number of Participants With Study Medication Satisfaction
timeFrame: 6, 24 hours, prior to rescue medication (assessed up to 24 hours)
measure: Plasma PF-05089771 Concentration
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
measure: Plasma Ibuprofen Concentration
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 28 (follow-up)
measure: Number of Participants With Clinically Significant Laboratory Findings
timeFrame: Baseline up to Day 7 to 10 (follow-up)
measure: Number of Participants With Clinically Significant Vital Signs
timeFrame: Baseline up to Day 7 to 10 (follow-up)
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Day 7 to 10 (follow-up)
Other outcomes:
Locations:
city: Austin
country: United States
facility: Central Texas Oral Surgery Associates
state: Texas
city: Austin
country: United States
facility: Premier Research Group Limited
state: Texas
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: