Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

May 25, 2018 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
235

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Development, LP
      • Austin, Texas, United States, 78705
        • Premier Research Group Limited
      • Austin, Texas, United States, 78705
        • Central Texas Oral Surgery Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
ACTIVE_COMPARATOR: Ibuprofen 400 mg
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Drug: Ibuprofen
2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
EXPERIMENTAL: PF-05089771 1600 mg
Drug: PF-05089771
A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Drug: PF-05089771
A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
Drug: PF-05089771
A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
EXPERIMENTAL: PF-05089771 450 mg
Drug: PF-05089771
A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Drug: PF-05089771
A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
Drug: PF-05089771
A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
EXPERIMENTAL: PF-05089771 150 mg
Drug: PF-05089771
A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Drug: PF-05089771
A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
Drug: PF-05089771
A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Pain Relief From 0 to 6 Hours (TOTPAR[6])
Time Frame: 0 to 6 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Peak Pain Relief (PPR)
Time Frame: 0 to 24 hours
PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).
0 to 24 hours
Pain Relief (PR) Score
Time Frame: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).
15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
Pain Intensity Difference (PID)
Time Frame: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
PID was calculated as pain intensity at baseline (baseline pain severity score range 2 [moderate] to 3 [severe]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 [none] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).
15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
Summed Pain Intensity Difference (SPID)
Time Frame: 0 to 6 hours; 0 to 24 hours
SPID: area under the PID effect curve from 0 to 6 hours (SPID[6]) and 0 to 24 hours (SPID[24]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
0 to 6 hours; 0 to 24 hours
Total Pain Relief From 0 to 24 Hours (TOTPAR[24])
Time Frame: 0 to 24 hours
TOTPAR(24) was defined as the total area under the PR curve through the first 24 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 the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate
0 to 24 hours
Time to Onset of First Perceptible Pain Relief
Time Frame: 0 to 24 hours
Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief.
0 to 24 hours
Time to Onset of Meaningful Pain Relief
Time Frame: 0 to 24 hours
Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief.
0 to 24 hours
Time to First Use of Rescue Medication
Time Frame: 0 to 24 hours
Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.
0 to 24 hours
Number of Participants With Global Evaluation of Study Medication
Time Frame: 6, 24 hours, prior to rescue medication (assessed up to 24 hours)
Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication[RM]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent.
6, 24 hours, prior to rescue medication (assessed up to 24 hours)
Number of Participants With Study Medication Satisfaction
Time Frame: 6, 24 hours, prior to rescue medication (assessed up to 24 hours)
Participants provided assessment regarding satisfaction with study medication (SM) for pain relief (PR) and overall performance (OP) on a 5-point categorical scale, 1=very dissatisfied (VD), 2=somewhat dissatisfied (SD), 3=neither satisfied nor dissatisfied (NSND), 4=somewhat satisfied (SS) and 5=very satisfied (VS).
6, 24 hours, prior to rescue medication (assessed up to 24 hours)
Plasma PF-05089771 Concentration
Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
Plasma Ibuprofen Concentration
Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
Ibuprofen concentration was reported separately for 2 isomers of ibuprofen: (S)-Ibuprofen, and (R)-Ibuprofen, where S implied sinister (clockwise configuration) and R implied rectus (anti-clockwise configuration).
0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline up to Day 28 (follow-up)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 28 days that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to Day 28 (follow-up)
Number of Participants With Clinically Significant Laboratory Findings
Time Frame: Baseline up to Day 7 to 10 (follow-up)
Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes), blood chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, blood urea nitrogen, fasting glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase), and urinalysis (urine white blood cells, urine red blood cells) were performed.
Baseline up to Day 7 to 10 (follow-up)
Number of Participants With Clinically Significant Vital Signs
Time Frame: Baseline up to Day 7 to 10 (follow-up)
Clinically significant vital signs: supine/sitting pulse rate (PR) less than (<) 40 or more than (>) 120 beats per minute (bpm), standing PR <40 or >140 bpm; systolic blood pressure (BP) >=30 millimeters of mercury (mmHg) change from baseline; absolute systolic BP <90 mmHg; diastolic BP >=20 mmHg change from baseline; absolute systolic BP <50 mmHg.
Baseline up to Day 7 to 10 (follow-up)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time Frame: Baseline up to Day 7 to 10 (follow-up)
Clinically significant ECG abnormalities: PR interval >=300 milliseconds (msec); 25% increase from baseline in PR interval when baseline PR was >200 msec; an increase from baseline of >=50% in PR interval when baseline PR was <=200 msec; QRS interval >=140 msec; an increase from baseline of >=50% in QRS interval; corrected QT interval (QTc) >=500 msec.
Baseline up to Day 7 to 10 (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B3291009

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