Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Ibuprofen; Drug: Ibuprofen/acetaminophen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01559259

B5061001

Details and patient eligibility

About

This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.

Enrollment: 394 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females 16 to 40 years of age
• Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth

Exclusion criteria

• Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
• Pregnant or breastfeeding females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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394 participants in 5 patient groups, including a placebo group

Ibuprofen/acetaminophen (lower dose)

Experimental group

Treatment:

Drug: Ibuprofen/acetaminophen

Drug: Ibuprofen/acetaminophen

Drug: Ibuprofen/acetaminophen

Ibuprofen/acetaminophen (middle dose)

Experimental group

Treatment:

Drug: Ibuprofen/acetaminophen

Drug: Ibuprofen/acetaminophen

Drug: Ibuprofen/acetaminophen

Ibuprofen/acetaminophen (high dose)

Experimental group

Treatment:

Drug: Ibuprofen/acetaminophen

Drug: Ibuprofen/acetaminophen

Drug: Ibuprofen/acetaminophen

Ibuprofen

Active Comparator group

Treatment:

Drug: Ibuprofen

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo