Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

NCT01512160 | Terminated Phase 2 Results DMC

• 1 other identifier: B1351010
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.

Conditions

Post-surgical Dental Pain

Keywords

Post-surgical dental pain

Outcome Measures

Primary Outcomes (1)

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

  TOTPAR \[6\] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR \[6\]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.

  0 to 6 hours

Secondary Outcomes (25)

• Number of Participants With Peak Pain Relief (PPR)

  0 to 24 hours

• Time-specific Pain Relief (PR) Score

  0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)

• Time-specific Pain Intensity Difference (PID) Score

  15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM

• Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours

  0 to 6, 0 to 24 hours

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

  0 to 24 hours

Study Arms (4)

PF-04531083 2000 mg

EXPERIMENTAL

Drug: PF-04531083; Other: Placebo

PF-04531083 1000 mg

EXPERIMENTAL

Drug: PF-04531083; Other: Placebo

Ibuprofen 400 mg

ACTIVE COMPARATOR

Drug: Ibuprofen; Other: Placebo

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

PF-04531083 DRUG

2000 mg oral solution

PF-04531083 2000 mg

Placebo OTHER

Placebo tablets for Ibuprofen

PF-04531083 2000 mg

Ibuprofen DRUG

2 x 200 mg tablets

Ibuprofen 400 mg

Eligibility Criteria

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

You may qualify if:

• Oral surgical procedure having removed 2 third molars (unilateral).
• Pre-dose pain intensity score (100 mm Visual Analog Scale \[VAS\]) \>50 mm within 5 hours of oral surgery.
• Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.

You may not qualify if:

• Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.
• Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
• Recent history of chronic analgesic or tranquilizer dependency.
• Active dental infection at the time of surgery.
• Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting \> 30 minutes.
• Subjects who are smokers.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Austin, Texas, 78744, United States

Location

Related Links

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

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Study was terminated for futility based on results of interim analysis.

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: August 30, 2011
• First Posted: January 19, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 28, 2013
• Results First Posted: June 28, 2013

Record last verified: 2013-05

Locations

US (1)