ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01529346
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Postoperative Dental Pain Drug: PF-05089771 Other: Placebo Drug: Ibuprofen Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 12, 2011
Actual Primary Completion Date : June 25, 2012
Actual Study Completion Date : June 25, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

Arm Intervention/treatment
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

Experimental: PF-05089771 450 mg Drug: PF-05089771
A single dose of PF-05089771 450 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

Experimental: PF-05089771 150 mg 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 tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

Active Comparator: Ibuprofen 400 mg Drug: Ibuprofen
2 X 200 mg tablets of ibuprofen 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

Placebo Comparator: Placebo 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. Plasma PF-05089771 Concentration [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose ]
  12. 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).

  13. 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.

  14. 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.

  15. 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.

  16. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529346


Locations
United States, Texas
Central Texas Oral Surgery Associates
Austin, Texas, United States, 78705
Premier Research Group Limited
Austin, Texas, United States, 78705
PPD Development, LP
Austin, Texas, United States, 78744
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01529346     History of Changes
Other Study ID Numbers: B3291009
First Posted: February 8, 2012    Key Record Dates
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018
Last Verified: May 2018

Keywords provided by Pfizer:
Postoperative dental pain

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action