Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

NCT01529346 | Completed Phase 2 Results

• 1 other identifier: B3291009
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Dental Pain

Keywords

Postoperative dental pain

Outcome Measures

Primary Outcomes (1)

• Total Pain Relief From 0 to 6 Hours (TOTPAR[6])

  TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.

  0 to 6 hours

Secondary Outcomes (16)

• Number of Participants With Peak Pain Relief (PPR)

  0 to 24 hours

• Pain Relief (PR) Score

  15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours

• Pain Intensity Difference (PID)

  15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours

• Summed Pain Intensity Difference (SPID)

  0 to 6 hours; 0 to 24 hours

• Total Pain Relief From 0 to 24 Hours (TOTPAR[24])

  0 to 24 hours

Study Arms (5)

PF-05089771 1600 mg

EXPERIMENTAL

Drug: PF-05089771; Other: Placebo

PF-05089771 450 mg

EXPERIMENTAL

Drug: PF-05089771; Other: Placebo

PF-05089771 150 mg

EXPERIMENTAL

Drug: PF-05089771; Other: Placebo

Ibuprofen 400 mg

ACTIVE COMPARATOR

Drug: Ibuprofen; Other: Placebo

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

PF-05089771 DRUG

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

PF-05089771 1600 mg

Placebo OTHER

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

PF-05089771 1600 mg

Ibuprofen DRUG

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

Ibuprofen 400 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Central Texas Oral Surgery Associates

Austin, Texas, 78705, United States

Location

Premier Research Group Limited

Austin, Texas, 78705, United States

Location

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-05089771; Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: February 8, 2012
• Study Start: December 12, 2011
• Primary Completion: June 25, 2012
• Study Completion: June 25, 2012
• Last Updated: June 1, 2018
• Results First Posted: June 1, 2018

Record last verified: 2018-05

Locations

US (3)