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Can a new form of ibuprofen beat standard pain relief for back pain?

NCT ID NCT04772781

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This phase II trial tests whether S(+) ibuprofen, a modified form of the common painkiller, provides better pain relief than a standard treatment for people with sudden, at least moderate low back pain. Researchers will compare the two approaches in 177 adults whose pain started within the last three days. The main goal is to see if more participants achieve at least 50% pain relief with S(+) ibuprofen, while also tracking side effects.

What this could mean

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

Active substance
S(+) ibuprofen, an experimental form of ibuprofen
What this could lead to
If it works, S(+) ibuprofen could offer a faster or more effective option for sudden low back pain.
What could go wrong
This is an early phase II trial with 177 participants, so results may not apply to everyone. The drug may not prove better than existing treatments, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

177 people

The number who actually took part.

Started

Jun 2022

Finished

May 2023

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Patient with acute low back pain who responds to the pain period less than or equal to 3 days; 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; * Current or previous history (less than 12 months) of smoking; * Have clinically relevant abnormal laboratory results according to medical evaluation; * Women who are pregnant, lactating, or positive for β - hCG urine test.

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Conditions

The condition(s) this trial relates to.

agnosia Inflammation Low Back Pain

As listed by the trial registrant

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

Acute low back pain Low back pain Low back pain, mechanical

Contacts and locations

Locations

  • Apsen Farmacêutica S.A.

    São Paulo, São Paulo, 04753-001, Brazil

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