NCT03404206

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

A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Naproxen Sodium (Aleve, BAY117031)	220 mg x 2 tablets, oral, single dose
DRUG	Ibuprofen (Advil)	200 mg x 2 tablets, oral, single dose
DRUG	Placebo	Matching placebo, 2 tablets, oral, single dose

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-07-06
• Completion: 2018-07-10
• First posted: 2018-01-19
• Last updated: 2019-07-18
• Results posted: 2019-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study