Clinical trial NCT01216163: Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Official title: Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Pain following third molar extraction (wisdom tooth)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 218
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \[including alcohol\])

Primary outcomes:
measure: Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
timeFrame: 0 to 6 hours
measure: Time to Onset of Meaningful Relief
timeFrame: 0 to 6 hours
Secondary outcomes:
measure: Time to Confirmed First Perceptible Relief
timeFrame: 0 to 6 hours
measure: Pain Relief Rating (PRR)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
measure: Pain Intensity Difference (PID)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
measure: Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
measure: Time-weighted Sum of Pain Intensity Difference (SPID)
timeFrame: 0 to 2, 0 to 3, 0 to 6 hours
measure: Time-weighted Sum of Pain Relief Rating (TOTPAR)
timeFrame: 0 to 2, 0 to 3, 0 to 6 hours
measure: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
timeFrame: 0 to 2, 0 to 3 hours
measure: Cumulative Percentage of Participants With Meaningful Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
measure: Cumulative Percentage of Participants With Confirmed First Perceptible Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
measure: Time to Treatment Failure
timeFrame: 0 to 6 hours
measure: Cumulative Percentage of Participants With Treatment Failure
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
measure: Cumulative Percentage of Participants With Complete Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
measure: Participant Global Evaluation of Study Medication
timeFrame: 6 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.