A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2018-07-10

Brief Summary

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To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.

To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

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Detailed Description

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Conditions

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Pain, Postoperative

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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Naproxen Sodium (Aleve, BAY117031)

Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization

Group Type EXPERIMENTAL

Naproxen Sodium (Aleve, BAY117031)

Intervention Type DRUG

220 mg x 2 tablets, oral, single dose

Ibuprofen (Advil)

Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization

Group Type ACTIVE_COMPARATOR

Ibuprofen (Advil)

Intervention Type DRUG

200 mg x 2 tablets, oral, single dose

Placebo

Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo, 2 tablets, oral, single dose

Interventions

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Naproxen Sodium (Aleve, BAY117031)

220 mg x 2 tablets, oral, single dose

Intervention Type DRUG

Ibuprofen (Advil)

200 mg x 2 tablets, oral, single dose

Intervention Type DRUG

Placebo

Matching placebo, 2 tablets, oral, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, ambulatory, male or female volunteers 16-40 years of age;
* Body mass index 18.0 to 30.0 kg/m\^2 inclusive;
* Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
* Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;

Exclusion Criteria

* History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
* Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
* Relevant concomitant disease such as asthma (exercise induced asthma is permitted)

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No