Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-12

Study Completion Date

2012-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-05089771 1600 mg

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively

Placebo

Intervention Type OTHER

Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

PF-05089771 450 mg

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively

Placebo

Intervention Type OTHER

Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

PF-05089771 150 mg

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively

Placebo

Intervention Type OTHER

Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Ibuprofen 400 mg

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively

Placebo

Intervention Type OTHER

Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively

Placebo

Intervention Type OTHER

Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Interventions

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PF-05089771

A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively

Intervention Type DRUG

Placebo

Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Intervention Type OTHER

PF-05089771

A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively

Intervention Type DRUG

Placebo

Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Intervention Type OTHER

PF-05089771

A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively

Intervention Type DRUG

Placebo

Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Intervention Type OTHER

Ibuprofen

2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively

Intervention Type DRUG

Placebo

Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively

Intervention Type OTHER

Placebo

Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively

Intervention Type OTHER

Placebo

Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No