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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

NCT05485805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2025-03-25

Study results available
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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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-01-25
Completion
2024-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485805 on ClinicalTrials.gov