Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain
Overview
- Phase
- Phase 3
- Intervention
- Novel Ibuprofen
- Conditions
- Pain
- Sponsor
- Pfizer
- Enrollment
- 218
- Locations
- 1
- Primary Endpoint
- Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Normal, healthy males and females 16 to 40 years of age
- •Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating \[VAS-PSR\] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- •Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide
Exclusion Criteria
- •Pregnancy or breast-feeding
- •Alcohol or substance abuse
- •Any serious medical or psychiatric disorder
- •History of stomach ulcers, stomach bleed, or other bleeding disorders
- •Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants \[including alcohol\])
Arms & Interventions
Treatment A
Intervention: Novel Ibuprofen
Treatment B
Intervention: Acetaminophen
Treatment C
Intervention: Placebo
Outcomes
Primary Outcomes
Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
Time Frame: 0 to 6 hours
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time to Onset of Meaningful Relief
Time Frame: 0 to 6 hours
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Secondary Outcomes
- Time to Confirmed First Perceptible Relief(0 to 6 hours)
- Pain Relief Rating (PRR)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
- Pain Intensity Difference (PID)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
- Sum of Pain Relief Rating and Pain Intensity Difference (PRID)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
- Time-weighted Sum of Pain Intensity Difference (SPID)(0 to 2, 0 to 3, 0 to 6 hours)
- Time-weighted Sum of Pain Relief Rating (TOTPAR)(0 to 2, 0 to 3, 0 to 6 hours)
- Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)(0 to 2, 0 to 3 hours)
- Cumulative Percentage of Participants With Meaningful Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
- Cumulative Percentage of Participants With Confirmed First Perceptible Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
- Time to Treatment Failure(0 to 6 hours)
- Cumulative Percentage of Participants With Treatment Failure(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
- Cumulative Percentage of Participants With Complete Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
- Participant Global Evaluation of Study Medication(6 hours)