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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

Group Type EXPERIMENTAL

Novel Ibuprofen

Intervention Type DRUG

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)

Treatment B

Group Type ACTIVE_COMPARATOR

Standard Ibuprofen

Intervention Type DRUG

Single-dose of standard ibuprofen (400mg)

Treatment C

Group Type ACTIVE_COMPARATOR

Standard Ibuprofen

Intervention Type DRUG

Single-dose of standard ibuprofen (400mg)

Treatment D

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single-dose of placebo

Interventions

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Novel Ibuprofen

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)

Intervention Type DRUG

Standard Ibuprofen

Single-dose of standard ibuprofen (400mg)

Intervention Type DRUG

Standard Ibuprofen

Single-dose of standard ibuprofen (400mg)

Intervention Type DRUG

Placebo

Single-dose of placebo

Intervention Type DRUG

Eligibility Criteria

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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\[including alcohol\])

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No