Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

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Detailed Description

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Conditions

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Toothache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Naproxen sodium ER (BAYH6689)

single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Group Type EXPERIMENTAL

Naproxen Sodium ER (BAYH6689)

Intervention Type DRUG

Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery

Placebo

Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery

Interventions

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Naproxen Sodium ER (BAYH6689)

Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery

Intervention Type DRUG

Placebo

Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, ambulatory, male and female volunteers between 16 to 45
* Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction
* No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any other pain reliever (Over The Counter or prescription), or herbal supplements within 5 days of surgery
* Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of \>/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale

Exclusion Criteria

* History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies
* Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study
* Current or past history of bleeding disorder(s)
* History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes