Back to resultsEfficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
Primary Purpose
Post-surgical Dental Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-04531083
Placebo
PF-04531083
Placebo
Ibuprofen
Placebo
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-surgical Dental Pain focused on measuring Post-surgical dental pain
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
PF-04531083 2000 mg
PF-04531083 1000 mg
Ibuprofen 400 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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).
Time-specific 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) at each relevant time points.
Time-specific Pain Intensity Difference (PID) Score
Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.
Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours
Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.
Total Pain Relief (TOTPAR) Score From 0 to 24 Hours
TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was 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 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.
Time to Onset of First Perceptible Pain Relief (PR)
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.
Time to Onset of First Meaningful Pain Relief (PR)
Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful 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 (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.
Number of Participants With Rescue Medication
Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.
Participant Global Evaluation of Study Medication
Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.
Participant Satisfaction Questionnaire
Participant's response to 2 questions about "how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.
Maximum Observed Plasma Concentration (Cmax) of PF-04531083
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083
AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083
AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.
Maximum Observed Plasma Concentration (Cmax) of Ibuprofen
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen
AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen
AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.
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/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.
Number of Participants With Clinically Significant Laboratory Test Abnormality
Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.
Supine Systolic and Diastolic Blood Pressure (BP)
Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)
Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).
12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)
Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.
Supine Pulse Rate
Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01512160
Brief Title
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
Official Title
A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-surgical Dental Pain
Keywords
Post-surgical dental pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04531083 2000 mg
Arm Type
Experimental
Arm Title
PF-04531083 1000 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-04531083
Intervention Description
2000 mg oral solution
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for Ibuprofen
Intervention Type
Drug
Intervention Name(s)
PF-04531083
Intervention Description
1000 mg oral solution
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for Ibuprofen
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
2 x 200 mg tablets
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for PF-04531083
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for PF-04531083
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for Ibuprofen
Primary Outcome Measure Information:
Title
Total Pain Relief (TOTPAR) Score From 0 to 6 Hours
Description
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.
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
Time-specific 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) at each relevant time points.
Time Frame
0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)
Title
Time-specific Pain Intensity Difference (PID) Score
Description
Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.
Time Frame
15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM
Title
Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours
Description
Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.
Time Frame
0 to 6, 0 to 24 hours
Title
Total Pain Relief (TOTPAR) Score From 0 to 24 Hours
Description
TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was 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 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.
Time Frame
0 to 24 hours
Title
Time to Onset of First Perceptible Pain Relief (PR)
Description
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.
Time Frame
0 to 24 hours
Title
Time to Onset of First Meaningful Pain Relief (PR)
Description
Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful 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 (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.
Time Frame
1.5 to 24 hours
Title
Number of Participants With Rescue Medication
Description
Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.
Time Frame
0 to 24 hours
Title
Participant Global Evaluation of Study Medication
Description
Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.
Time Frame
6, 24 hours, prior to RM
Title
Participant Satisfaction Questionnaire
Description
Participant's response to 2 questions about "how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.
Time Frame
6, 24 hours, prior to RM
Title
Maximum Observed Plasma Concentration (Cmax) of PF-04531083
Time Frame
0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083
Time Frame
0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
Title
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083
Description
AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.
Time Frame
0 (pre-dose), 1, 2, 4, 6 hours post-dose
Title
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083
Description
AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.
Time Frame
0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
Title
Maximum Observed Plasma Concentration (Cmax) of Ibuprofen
Time Frame
0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen
Time Frame
0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
Title
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen
Description
AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.
Time Frame
0 (pre-dose), 1, 2, 4, 6 hours post-dose
Title
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen
Description
AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.
Time Frame
0 (pre-dose), 1, 2, 4, 6, 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/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.
Time Frame
Baseline up to Day 10-14 (Follow-up)
Title
Number of Participants With Clinically Significant Laboratory Test Abnormality
Description
Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.
Time Frame
Baseline up to Day 10-14 (Follow-up)
Title
Supine Systolic and Diastolic Blood Pressure (BP)
Description
Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.
Time Frame
Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)
Title
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)
Description
Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).
Time Frame
Screening, Day 1, 2, 10-14 (Follow-up)
Title
12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)
Description
Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.
Time Frame
Screening, Day 1, 2, 10-14 (Follow-up)
Title
Supine Pulse Rate
Description
Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.
Time Frame
Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Pfizer Investigational Site
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=B1351010&StudyName=Efficacy%20Of%20Pf-04531083%20In%20Treating%20Post-Surgical%20Dental%20Pain
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
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