Post-surgical Dental Pain Clinical Trial
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
| Verified date | May 2013 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 90 |
| Est. completion date | May 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 55 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 0 to 6 hours | No |
| Secondary | 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). | 0 to 24 hours | No |
| Secondary | 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. | 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM) | No |
| Secondary | 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. | 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM | No |
| Secondary | 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. | 0 to 6, 0 to 24 hours | No |
| Secondary | 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. | 0 to 24 hours | No |
| Secondary | 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. | 0 to 24 hours | No |
| Secondary | 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. | 0 to 24 hours | No |
| Secondary | 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. | 1.5 to 24 hours | No |
| Secondary | 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. | 0 to 24 hours | No |
| Secondary | 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. | 6, 24 hours, prior to RM | No |
| Secondary | 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. | 6, 24 hours, prior to RM | No |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04531083 | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | No | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083 | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | No | |
| Secondary | 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. | 0 (pre-dose), 1, 2, 4, 6 hours post-dose | No |
| Secondary | 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. | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | No |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ibuprofen | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | No | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | No | |
| Secondary | 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. | 0 (pre-dose), 1, 2, 4, 6 hours post-dose | No |
| Secondary | 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. | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | No |
| Secondary | 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. | Baseline up to Day 10-14 (Follow-up) | Yes |
| Secondary | 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. | Baseline up to Day 10-14 (Follow-up) | Yes |
| Secondary | 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. | Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up) | Yes |
| Secondary | 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). | Screening, Day 1, 2, 10-14 (Follow-up) | Yes |
| Secondary | 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. | Screening, Day 1, 2, 10-14 (Follow-up) | Yes |
| Secondary | Supine Pulse Rate | Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds. | Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up) | Yes |
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