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

Bayer

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Ibuprofen (Advil); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03404206

19762

2017-005049-67 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 387 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

387 participants in 3 patient groups, including a placebo group

Naproxen Sodium (Aleve, BAY117031)

Experimental group

Description:

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

Treatment:

Drug: Naproxen Sodium (Aleve, BAY117031)

Ibuprofen (Advil)

Active Comparator group

Description:

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

Treatment:

Drug: Ibuprofen (Advil)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo