Clinical trial NCT01098747: 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 I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Pain following third molar extraction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-05
Enrollment: 335
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 pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen 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 drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone 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 and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
timeFrame: 0 to 8 hours
measure: Time to Onset of Meaningful Relief
timeFrame: 0 to 8 hours
Secondary outcomes:
measure: Time to Confirmed First Perceptible Relief
timeFrame: 0 to 8 hours
measure: Pain Relief Rating (PRR)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
measure: Pain Intensity Difference (PID)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 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, 7, 8 hours
measure: Time-weighted Sum of Pain Intensity Difference (SPID)
timeFrame: 0-2, 0-3, 0-6, 0-8 hours
measure: Time-weighted Sum of Pain Relief Rating (TOTPAR)
timeFrame: 0-2, 0-3, 0-6, 0-8 hours
measure: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
timeFrame: 0-2, 0-3, 0-6, 0-8 hours
measure: Cumulative Percentage of Participants With Meaningful Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
measure: Cumulative Percentage of Participants With Confirmed First Perceptible Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
measure: Time to Treatment Failure
timeFrame: 0 to 8 hours
measure: Cumulative Percentage of Participants With Treatment Failure
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
measure: Cumulative Percentage of Participants With Complete Relief
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
measure: Participant Global Evaluation of Study Medication
timeFrame: 8 hours
Other outcomes:
Locations:
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.
citation: Brain P, Leyva R, Doyle G, Kellstein D. Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. Clin J Pain. 2015 May;31(5):444-50. doi: 10.1097/AJP.0000000000000142.