Back to resultsEfficacy Of PF-05089771 In Treating Postoperative Dental Pain
Primary Purpose
Postoperative Dental Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-05089771
Placebo
PF-05089771
Placebo
PF-05089771
Placebo
Ibuprofen
Placebo
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Dental Pain focused on measuring Postoperative dental pain
Eligibility 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.
Sites / Locations
- Central Texas Oral Surgery Associates
- Premier Research Group Limited
- PPD Development, LP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
PF-05089771 1600 mg
PF-05089771 450 mg
PF-05089771 150 mg
Ibuprofen 400 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Peak Pain Relief (PPR)
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).
Pain Relief (PR) Score
PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).
Pain Intensity Difference (PID)
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).
Summed Pain Intensity Difference (SPID)
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).
Total Pain Relief From 0 to 24 Hours (TOTPAR[24])
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
Time to Onset of First Perceptible Pain Relief
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.
Time to Onset of Meaningful Pain Relief
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.
Time to First Use of Rescue Medication
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.
Number of Participants With Global Evaluation of Study Medication
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.
Number of Participants With Study Medication Satisfaction
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).
Plasma PF-05089771 Concentration
Plasma Ibuprofen Concentration
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).
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
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.
Number of Participants With Clinically Significant Laboratory Findings
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.
Number of Participants With Clinically Significant Vital Signs
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.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529346
Brief Title
Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 12, 2011 (Actual)
Primary Completion Date
June 25, 2012 (Actual)
Study Completion Date
June 25, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Dental Pain
Keywords
Postoperative dental pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-05089771 1600 mg
Arm Type
Experimental
Arm Title
PF-05089771 450 mg
Arm Type
Experimental
Arm Title
PF-05089771 150 mg
Arm Type
Experimental
Arm Title
Ibuprofen 400 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-05089771
Intervention Description
A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Intervention Type
Drug
Intervention Name(s)
PF-05089771
Intervention Description
A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Intervention Type
Drug
Intervention Name(s)
PF-05089771
Intervention Description
A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Primary Outcome Measure Information:
Title
Total Pain Relief From 0 to 6 Hours (TOTPAR[6])
Description
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.
Time Frame
0 to 6 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Peak Pain Relief (PPR)
Description
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).
Time Frame
0 to 24 hours
Title
Pain Relief (PR) Score
Description
PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).
Time Frame
15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
Title
Pain Intensity Difference (PID)
Description
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).
Time Frame
15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours
Title
Summed Pain Intensity Difference (SPID)
Description
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).
Time Frame
0 to 6 hours; 0 to 24 hours
Title
Total Pain Relief From 0 to 24 Hours (TOTPAR[24])
Description
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
Time Frame
0 to 24 hours
Title
Time to Onset of First Perceptible Pain Relief
Description
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.
Time Frame
0 to 24 hours
Title
Time to Onset of Meaningful Pain Relief
Description
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.
Time Frame
0 to 24 hours
Title
Time to First Use of Rescue Medication
Description
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.
Time Frame
0 to 24 hours
Title
Number of Participants With Global Evaluation of Study Medication
Description
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.
Time Frame
6, 24 hours, prior to rescue medication (assessed up to 24 hours)
Title
Number of Participants With Study Medication Satisfaction
Description
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).
Time Frame
6, 24 hours, prior to rescue medication (assessed up to 24 hours)
Title
Plasma PF-05089771 Concentration
Time Frame
0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
Title
Plasma Ibuprofen Concentration
Description
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).
Time Frame
0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to Day 28 (follow-up)
Title
Number of Participants With Clinically Significant Laboratory Findings
Description
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.
Time Frame
Baseline up to Day 7 to 10 (follow-up)
Title
Number of Participants With Clinically Significant Vital Signs
Description
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.
Time Frame
Baseline up to Day 7 to 10 (follow-up)
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
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.
Time Frame
Baseline up to Day 7 to 10 (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Central Texas Oral Surgery Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Premier Research Group Limited
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
PPD Development, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3291009&StudyName=Efficacy%20Of%20PF-05089771%20In%20Treating%20Postoperative%20Dental%20Pain
Description
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Learn more about this trial
Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
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