OsteoarthritisPhase 2APS003/2020NCT04637529
Efficacy and Safety of S (+) - Ibuprofen in Osteoarthritis Pain
A Phase 2 study testing S (+) - Ibuprofen and Ibuvix® - ibuprofen in people with Osteoarthritis, 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 diagnosed with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- S (+) - Ibuprofen and Ibuvix® - ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2022to 30 Jun 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 75 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;
- Patients aged from 18 to 75 with a diagnosis of knee and/or hip osteoarthritis according to American College of Rheumatology (ACR) criteria.
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 Osteoarthritis
The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals diagnosed with osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- S (+) - Ibuprofen, Ibuvix® - ibuprofen
- Keywords
- Nonsteroidal anti-inflammatory, Pain, Ibuprofen, Inflammation, Anti-inflammatory, Pain control, Osteoarthritis, Pain relief, Enzyme Inhibitors
- Medical subject headings
- Osteoarthritis, Pain, Inflammation, Agnosia
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 Ibuvix®
Ibuvix® - ibuprofenDrug
Ibuvix® + placebo of S(+) - Ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| S (+) - Ibuprofen | Experimental | S (+) - Ibuprofen (1 coated tablet) + placebo of Ibuvix® - ibuprofen (1 coated tablet) Every 6 hours for 28 days. Receives: Drug: S (+) - Ibuprofen |
| Ibuvix® - ibuprofen | Active comparator | Ibuvix® - ibuprofen (1 coated tablet) + placebo of S (+) - Ibuprofen (1 coated tablet) Every 6 hours for 28 days. Receives: Drug: Ibuvix® - ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)
Measured: Baseline (day 0) and Week 4 (day 28)
Secondary outcomes (2)
Patient Global Impression of Improvement-I (PGI-I)
Measured: Week 4 (day 28)
Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability
Measured: From Baseline (day 0) to Week 4 (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start5 Aug 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 176 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
- NCT04637529
- Sponsor's protocol ID
- APS003/2020
- Acronym
- APS003/2020
- Status last verified
- Jul 2023
- First submitted
- 18 Nov 2020
- 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 Osteoarthritis
- ClinicalTrials.gov ID
- NCT04637529
- Acronym / sponsor ID
- APS003/2020 / APS003/2020
- Conditions
- Osteoarthritis
- Keywords
- Nonsteroidal anti-inflammatory, Pain, Ibuprofen, Inflammation, Anti-inflammatory, Pain control, Osteoarthritis, Pain relief
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Nov 2020 (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 diagnosed with osteoarthritis.
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 (+) - IbuprofenS (+) - Ibuprofen (1 coated tablet) + placebo of Ibuvix® - ibuprofen (1 coated tablet) Every 6 hours for 28 days. |
| Ibuvix® - ibuprofen | Active comparator | Drug: Ibuvix® - ibuprofenIbuvix® - ibuprofen (1 coated tablet) + placebo of S (+) - Ibuprofen (1 coated tablet) Every 6 hours for 28 days. |
Who may qualify
- Ages
- 18 to 75 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 Ibuvix® | Drug | S (+) - Ibuprofen |
| Ibuvix® - ibuprofenIbuvix® + placebo of S(+) - Ibuprofen | Drug | Ibuvix® - ibuprofen |
Primary outcome
Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)
Time frame: Baseline (day 0) and Week 4 (day 28)
2 secondary outcomes
Patient Global Impression of Improvement-I (PGI-I)
Time frame: Week 4 (day 28)
Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability
Time frame: From Baseline (day 0) to Week 4 (day 28)
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
Related trials for Osteoarthritis
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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 Ibuvix® - ibuprofen in people with Osteoarthritis, 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?
Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain) (time frame: Baseline (day 0) and Week 4 (day 28)). 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.