Postsurgical PainPhase 3CARLOTANCT04647435
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
A Phase 3 study testing APSCTC, Toragesic® and Tramal® in people with Postsurgical Pain and Third Molar Extraction, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postsurgical Pain, Third Molar Extraction
- What is being tested?
- APSCTC, Toragesic® and Tramal®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteBrazil
- Study dates
- 13 May 2023to 4 Oct 2024
- Phase
- Phase 3
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
Valinhos, São Paulo
About this study
Official title: National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.
The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.
- Conditions
- Postsurgical Pain, Third Molar Extraction
- Being tested
- APSCTC, Toragesic®, Tramal®
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APSCTCDrug
APSCTC + Toragesic® placebo + Tramal® placebo
Toragesic®Drug
APSCTC placebo + Toragesic® + Tramal® placebo
Tramal®Drug
APSCTC placebo + Toragesic® placebo + Tramal®
| Study group | Role | What they receive |
|---|---|---|
| APSCTC | Experimental | Oral tablets every 6h for 3 days Receives: Drug: APSCTC |
| Toragesic® | Active comparator | Oral tablets every 6h for 3 days Receives: Drug: Toragesic® |
| Tramal® | Active comparator | Oral tablets every 6h for 3 days Receives: Drug: Tramal® |
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 (TOTPARmax)
Measured: Change from Baseline to 6 hours
Secondary outcomes (1)
Adverse events incidence and classification
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 posted1 Dec 2020
- Study start13 May 2023
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 396 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
- NCT04647435
- Sponsor's protocol ID
- APS001/2020
- Acronym
- CARLOTA
- Status last verified
- Feb 2025
- First submitted
- 18 Nov 2020
- Last updated
- 4 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.
- ClinicalTrials.gov ID
- NCT04647435
- Acronym / sponsor ID
- CARLOTA / APS001/2020
- Conditions
- Postsurgical Pain, Third Molar Extraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 13 May 2023 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 1 Dec 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 APSCTC compared to two active drugs in acute pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APSCTC | Experimental | Drug: APSCTCOral tablets every 6h for 3 days |
| Toragesic® | Active comparator | Drug: Toragesic®Oral tablets every 6h for 3 days |
| Tramal® | Active comparator | Drug: Tramal®Oral tablets every 6h for 3 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| APSCTCAPSCTC + Toragesic® placebo + Tramal® placebo | Drug | APSCTC |
| Toragesic®APSCTC placebo + Toragesic® + Tramal® placebo | Drug | Toragesic® |
| Tramal®APSCTC placebo + Toragesic® placebo + Tramal® | Drug | Tramal® |
Primary outcome
At least 50% of maximum pain relief score (TOTPARmax)
Time frame: Change from Baseline to 6 hours
1 secondary outcome
Adverse events incidence and classification
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 4 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 3 study testing APSCTC, Toragesic® and Tramal® in people with Postsurgical Pain and Third Molar Extraction, 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 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (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 4 Sep 2026.