NCT05485805

A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo

A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Pivotal Trial to Confirm the Efficacy of a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Researchers are looking for a better way to relieve pain in people, such as after dental surgery. Participants in this study, have had 3 or 4 third molars (cheek teeth) removed and subsequently have moderate to severe tooth pain. The study treatment naproxen sodium suppresses inflammatory pain by reducing inflammation. In the US, naproxen has been marketed since 1976, and naproxen sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea, or cocoa, has been shown to enhance the effect of various painkillers, and therefore is accepted as an additive. The main purpose of this study is to learn how well a fixed-dose combination of naproxen sodium and caffeine relieves pain compared to each single ingredient as well as to placebo in participants after molar removal. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the researchers will compare the amount of pain decrease over 8 hours in participants who received a single dose of either: * 1 fixed-dose tablet of naproxen sodium/caffeine * 2 fixed-dose tablets of naproxen sodium/caffeine * naproxen sodium only * caffeine only * or placebo The study participants will be randomly (by chance) assigned to one of the five treatment groups. They will take a single dose of two tablets by mouth within 4.5 hours after the surgery. If there is no pain relief within 2 hours after intake, other painkillers may be given.

Conditions

• Postoperative Dental Pain

Interventions

Type	Name	Description
DRUG	Naproxen sodium and caffeine (BAY2880376)	Tablet, oral use, single dose
DRUG	Naproxen sodium (Aleve)	Tablet, oral use, single dose
DRUG	Caffeine	Tablet, oral use, single dose
DRUG	Placebo	Tablet, oral use, single dose

Timeline

• Start date: 2022-09-21
• Primary completion: 2024-01-25
• Completion: 2024-01-29
• First posted: 2022-08-03
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study