Status:
COMPLETED
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Lead Sponsor:
Bayer
Conditions:
Toothache
Eligibility:
All Genders
16-45 years
Phase:
PHASE3
Brief Summary
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00720057
Start Date
June 1 2008
End Date
August 1 2008
Last Update
August 25 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Austin, Texas, United States, 78705
2
Austin, Texas, United States, 78744
3
Salt Lake City, Utah, United States, 84124