Low Back Pain, MechanicalPhase 2APS002/2020NCT04772781
Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain
A Phase 2 study testing S (+) - Ibuprofen and Ibuflex® in people with Low Back Pain, Mechanical and Low Back Pain, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical, Low Back Pain, Acute Low Back Pain
- What is being tested?
- S (+) - Ibuprofen and Ibuflex®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jun 2022to 25 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With At Least Moderate Mechanical Acute Low Back Pain
The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.
- Being tested
- S (+) - Ibuprofen, Ibuflex®
- Keywords
- Pain control, Low back pain, Pain relief, Ibuprofen, Inflammation, Anti-inflammatory
- Medical subject headings
- Low Back Pain, Agnosia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S (+) - IbuprofenDrug
S (+) - Ibuprofen + placebo of Ibuflex®
Ibuflex®Drug
Ibuflex® + placebo of S (+) - Ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| S (+) - Ibuprofen | Experimental | Not described Receives: Drug: S (+) - Ibuprofen |
| Ibuflex® - ibuprofen | Active comparator | Not described Receives: Drug: Ibuflex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)
TOTPAR was calculated using data from a 5-point categorical pain relief scale (none = 0, slight = 1, moderate = 2, good = 3, or complete pain relief = 4)
Measured: Change from Baseline to 6 hours
Secondary outcomes (1)
Adverse events rates between groups
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start3 Jun 2022
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772781
- Sponsor's protocol ID
- APS002/2020
- Acronym
- APS002/2020
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With At Least Moderate Mechanical Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT04772781
- Acronym / sponsor ID
- APS002/2020 / APS002/2020
- Keywords
- Pain control, Low back pain, Pain relief, Ibuprofen, Inflammation, Anti-inflammatory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S (+) - Ibuprofen | Experimental | Drug: S (+) - Ibuprofen |
| Ibuflex® - ibuprofen | Active comparator | Drug: Ibuflex® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S (+) - IbuprofenS (+) - Ibuprofen + placebo of Ibuflex® | Drug | S (+) - Ibuprofen |
| Ibuflex®Ibuflex® + placebo of S (+) - Ibuprofen | Drug | Ibuflex® - ibuprofen |
Primary outcome
At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)
Time frame: Change from Baseline to 6 hours
TOTPAR was calculated using data from a 5-point categorical pain relief scale (none = 0, slight = 1, moderate = 2, good = 3, or complete pain relief = 4)
1 secondary outcome
Adverse events rates between groups
Time frame: During treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S (+) - Ibuprofen and Ibuflex® in people with Low Back Pain, Mechanical and Low Back Pain, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax) (time frame: Change from Baseline to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.