Trial Condition(s):

Toothache

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

Bayer Identifier:

13130

ClinicalTrials.gov Identifier:

NCT00720057

EudraCT Number:

2014-005269-66

Study Completed

Trial Purpose

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

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)

Trial Summary

Enrollment Goal
312
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Jean Brown Research

Salt Lake City, United States, 84124

Status
Completed
 
Locations

Pharmaceutical Product Development, LLC

Austin, United States, 78744

Status
Completed
 
Locations

SCIREX-Premier Clinical Research

Austin, United States, 78705

Status
Completed
 

Trial Design