Clinical trial NCT01512160: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-surgical Dental Pain
Keywords: Post-surgical dental pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total Pain Relief (TOTPAR) Score From 0 to 6 Hours
timeFrame: 0 to 6 hours
Secondary outcomes:
measure: Number of Participants With Peak Pain Relief (PPR)
timeFrame: 0 to 24 hours
measure: Time-specific Pain Relief (PR) Score
timeFrame: 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)
measure: Time-specific Pain Intensity Difference (PID) Score
timeFrame: 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM
measure: Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours
timeFrame: 0 to 6, 0 to 24 hours
measure: Total Pain Relief (TOTPAR) Score From 0 to 24 Hours
timeFrame: 0 to 24 hours
measure: Time to Onset of First Perceptible Pain Relief (PR)
timeFrame: 0 to 24 hours
measure: Time to Onset of First Meaningful Pain Relief (PR)
timeFrame: 0 to 24 hours
measure: Time to First Use of Rescue Medication
timeFrame: 1.5 to 24 hours
measure: Number of Participants With Rescue Medication
timeFrame: 0 to 24 hours
measure: Participant Global Evaluation of Study Medication
timeFrame: 6, 24 hours, prior to RM
measure: Participant Satisfaction Questionnaire
timeFrame: 6, 24 hours, prior to RM
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04531083
timeFrame: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083
timeFrame: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
measure: Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083
timeFrame: 0 (pre-dose), 1, 2, 4, 6 hours post-dose
measure: Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083
timeFrame: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Ibuprofen
timeFrame: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen
timeFrame: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
measure: Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen
timeFrame: 0 (pre-dose), 1, 2, 4, 6 hours post-dose
measure: Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen
timeFrame: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 10-14 (Follow-up)
measure: Number of Participants With Clinically Significant Laboratory Test Abnormality
timeFrame: Baseline up to Day 10-14 (Follow-up)
measure: Supine Systolic and Diastolic Blood Pressure (BP)
timeFrame: Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)
measure: 12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)
timeFrame: Screening, Day 1, 2, 10-14 (Follow-up)
measure: 12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)
timeFrame: Screening, Day 1, 2, 10-14 (Follow-up)
measure: Supine Pulse Rate
timeFrame: Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)
Other outcomes:
Locations:
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: