Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Novel Ibuprofen; Drug: Placebo; Drug: Acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01216163

B3411002

AH-09-14

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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])

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 3 patient groups, including a placebo group

Treatment A

Experimental group

Treatment:

Drug: Novel Ibuprofen

Treatment B

Active Comparator group

Treatment:

Drug: Acetaminophen

Treatment C

Placebo Comparator group

Treatment:

Drug: Placebo