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Can a new drug beat standard painkillers for Post-Dental surgery pain?

NCT ID NCT04647435

Symptom relief Sponsor: Apsen Farmaceutica S.A. Source: ClinicalTrials.gov ↗

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Last updated Sep 04, 2026

Summary

This phase 3 trial enrolls adults aged 18 to 40 who need an impacted wisdom tooth removed. Researchers compare the experimental drug APSCTC against two established painkillers to see if it provides better relief from post-surgical pain. Participants receive one of the treatments in a double-blind setup, and the study measures how many achieve at least 50% pain relief. The trial also tracks side effects to assess safety.

What this could mean

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

Active substance
APSCTC, an experimental pain reliever, compared against two active drugs (Toragesic and Tramal)
What this could lead to
If APSCTC works, it could offer a new option for managing acute pain after dental surgery, with possibly fewer side effects than current treatments.
What could go wrong
This is an early-stage comparison, and APSCTC may not prove more effective or safer than existing painkillers. The trial focuses on short-term pain relief, not long-term outcomes.

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

396 people

The number who actually took part.

Started

May 2023

Finished

Oct 2024

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 40 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.

Main Inclusion Criteria: * Males and Females aged 18 to 40 years; * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Participants who require extraction of impacted mandibular third molar. Main Exclusion Criteria: * Known hypersensitivity to the formula components used during the clinical trial; * Previous history of alcohol or drugs abuse diagnosed by DSM-V; * Previous history of renal failure from moderate to severe; * Women who are pregnant, lactating, or positive for β - hCG urine test.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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

Postsurgical pain Third molar extraction

Contacts and locations

Locations

  • Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

    Valinhos, São Paulo, Brazil

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