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One pill for dental pain? researchers test a Two-Drug combo

NCT ID NCT03127592

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether a single pill combining etodolac, an anti-inflammatory painkiller, and cyclobenzaprine, a muscle relaxant, controls pain and swelling better than either drug taken alone. The trial enrolls about 140 healthy adults who have had an impacted wisdom tooth removed. Participants receive one of the three treatments, and researchers track pain scores and swelling over several days to compare how well each option works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a fixed-dose combination pill of etodolac, an anti-inflammatory painkiller, and cyclobenzaprine, a muscle relaxant
What this could lead to
If the combination works better than either drug alone, it could offer a single pill for stronger, more convenient relief after dental surgery.
What could go wrong
Combining two drugs can add side effects such as drowsiness, stomach upset, or dizziness, and the pair may not outperform each drug used separately. Results from one dental surgery setting may not apply to other types of pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

140 people

The number who actually took part.

Started

Oct 2020

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy research participants of both sexes (male and female non-pregnant), aged 18 years or over, underwent impacted third molar extraction surgery Exclusion Criteria: * Presence of any event and / or pathology at the site of interest that may interfere with and contraindicate the performance of the surgical procedure at the discretion of the Investigator, including periodontitis, odontogenic tumors or cysts (associated or not with the third molar), trauma, presence of Inflammation and / or infection; * Present or past history of any cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological event; * Previous diagnosis of alcohol and drug abuse defined by DSM-V; * Current or past history (for less than 12 months) of smoking; * Use of illicit drugs; * History of bleeding / bleeding or coagulation disorders, gastric ulcer and / or active peptic hemorrhage; * Any finding of clinical (clinical / physical), laboratory or cardiac evaluation (ECG) observation that is interpreted by the investigating physician as a risk to the participant; * Use of drugs that potentially interfere with the kinetics / dynamics of acetaminophen or any other medicinal product considered clinically significant by the Investigator; * Known hypersensitivity to the active principles used during the study (etodolac and cyclobenzaprine); * Women in gestation or breastfeeding, as well as women who present a positive pregnancy test (β - hCG) during the study screening / selection period; * Professionals directly involved in the realization of the present study and their relatives; * Participant of the research that has participated in clinical study protocols in the last 12 (twelve) months, unless the Investigator deems that there may be direct benefit to it.

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Conditions

The condition(s) this trial relates to.

Acute Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

    Valinhos, São Paulo, 13271-130, Brazil

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