NCT03566979

Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Industry
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Detailed description

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Conditions

• Post-operative Dental Pain

Interventions

Type	Name	Description
DRUG	Test naproxen sodium tablet	Single dose of 2 test naproxen sodium 220 mg tablets
DRUG	Commercial naproxen sodium tablet	Single dose of 2 naproxen sodium 220 mg tablets
DRUG	Commercial naproxen sodium liquid gels capsule	Single dose of 2 naproxen sodium 220 mg liquid gel capsules
DRUG	Placebo tablet	2 placebo tablets

Timeline

• Start date: 2018-08-13
• Primary completion: 2019-03-26
• Completion: 2019-04-15
• First posted: 2018-06-25
• Last updated: 2020-04-09
• Results posted: 2020-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study