Status:
COMPLETED
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Lead Sponsor:
Bayer
Conditions:
Pain, Postoperative
Eligibility:
All Genders
16-40 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2018
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT03404206
Start Date
February 12 2018
End Date
July 10 2018
Last Update
July 18 2019
Active Locations (1)
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1
Jean Brown Research
Salt Lake City, Utah, United States, 84124