MedDataX Logo

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

NCT ID: NCT01512160

Last Updated: 2013-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-surgical Dental Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Post-surgical dental pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-04531083 2000 mg

Group Type EXPERIMENTAL

PF-04531083

Intervention Type DRUG

2000 mg oral solution

Placebo

Intervention Type OTHER

Placebo tablets for Ibuprofen

PF-04531083 1000 mg

Group Type EXPERIMENTAL

PF-04531083

Intervention Type DRUG

1000 mg oral solution

Placebo

Intervention Type OTHER

Placebo tablets for Ibuprofen

Ibuprofen 400 mg

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

2 x 200 mg tablets

Placebo

Intervention Type OTHER

Placebo solution for PF-04531083

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo solution for PF-04531083

Placebo

Intervention Type OTHER

Placebo tablets for Ibuprofen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-04531083

2000 mg oral solution

Intervention Type DRUG

Placebo

Placebo tablets for Ibuprofen

Intervention Type OTHER

PF-04531083

1000 mg oral solution

Intervention Type DRUG

Placebo

Placebo tablets for Ibuprofen

Intervention Type OTHER

Ibuprofen

2 x 200 mg tablets

Intervention Type DRUG

Placebo

Placebo solution for PF-04531083

Intervention Type OTHER

Placebo

Placebo solution for PF-04531083

Intervention Type OTHER

Placebo

Placebo tablets for Ibuprofen

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1351010&StudyName=Efficacy%20Of%20Pf-04531083%20In%20Treating%20Post-Surgical%20Dental%20Pain

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B1351010

Identifier Type: -

Identifier Source: org_study_id