NCT04447040

Acetaminophen/Naproxen Sodium Dose Ranging Study

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Industry
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

Detailed description

This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:\[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo\] following surgical extraction of four third molars.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen/naproxen sodium Dose A	Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
DRUG	Acetaminophen/naproxen sodium Dose B	Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
DRUG	Acetaminophen/naproxen sodium Dose C	Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
DRUG	Acetaminophen/naproxen sodium Dose D	Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
DRUG	Acetaminophen/naproxen sodium Dose E	Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
DRUG	Placebo	Placebo tablets administered as a single two-tablet dose.

Timeline

• Start date: 2020-11-09
• Primary completion: 2021-04-09
• Completion: 2021-05-03
• First posted: 2020-06-25
• Last updated: 2025-03-24
• Results posted: 2024-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study