Acute PainPhase 3PIERRENCT07880392
Efficacy and Safety of DNN.63.18.040 for the Treatment of Moderate to Severe Pain
A Phase 3 study testing Product DNN.63.18.040 and Tramal® in people with Acute Pain, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
This study evaluates the safety and efficacy of DNN.63.18.040 compared with Tramal® for the treatment of moderate to severe pain. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Product DNN.63.18.040 and Tramal®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants aged 18 years or older and younger than 50 years;
- Underwent extraction of up to 2 impacted third molars requiring bone removal (ostectomy), classified as Pell and Gregory Class II or III and Position B or C;
- Following third molar extraction surgery, experienced moderate to severe pain, defined as a score ≥5 on an 11-point Numeric Rating Scale (NRS), within 5 hours after dental extraction.
Who cannot join
- Surgical duration greater than 4 hours;
- Active inflammatory conditions in the oral cavity due to causes other than inflammation resulting from third molar extraction surgery;
- Any radiologic finding (panoramic dental radiograph) that, in the investigator's opinion, may place the participant at risk if enrolled in the study.
- History or confirmed diagnosis of peptic ulcer disease, gastrointestinal disorders associated with nonsteroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding, or other active bleeding;
- History or confirmed diagnosis of acute or severe bronchial asthma;
- History or confirmed diagnosis of moderate to severe renal impairment, severe hepatic impairment, or severe cardiac impairment;
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- Use of sedative medications (e.g., benzodiazepines) or hypnotic agents that cannot be discontinued during the prohibited medication washout period specified in the protocol;
- Chronic treatment with opioid medications.
- Participants with pre-existing respiratory conditions, such as chronic obstructive pulmonary disease (COPD), sleep apnea, or respiratory failure, or those receiving other central nervous system (CNS) depressants, such as benzodiazepines or other opioids;
- History or confirmed diagnosis of anaphylactoid reactions (e.g., urticaria, rhinitis, angioedema) associated with the use of analgesics.
About this study
Official title: A Randomized Clinical Trial to Evaluate the Safety and Efficacy of DNN.63.18.040 for the Treatment of Moderate to Severe Pain
This study evaluates the safety and efficacy of DNN.63.18.040 compared with Tramal® for the treatment of moderate to severe pain.
- Conditions
- Acute Pain
- Being tested
- Product DNN.63.18.040, Tramal®
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product DNN.63.18.040Drug
One capsule four times daily for 3 days
Tramal®Drug
One capsule four times daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Product DNN.63.18.040 | Experimental | Not described Receives: Drug: Product DNN.63.18.040 |
| Tramal® | Active comparator | Not described Receives: Drug: Tramal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pain Relief Score (TOTPAR6)
Time-weighted sum of pain relief scores over the first 6 hours following the first dose. Pain relief is rated on a scale from 0 (no relief) to 4 (complete relief). TOTPAR6 ranges from 0 to 24, with higher scores indicating greater overall pain relief.
Measured: 6 hours after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880392
- Sponsor's protocol ID
- ACH-TRD-03(02/21)
- Acronym
- PIERRE
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate the Safety and Efficacy of DNN.63.18.040 for the Treatment of Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT07880392
- Acronym / sponsor ID
- PIERRE / ACH-TRD-03(02/21)
- Conditions
- Acute Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
This study evaluates the safety and efficacy of DNN.63.18.040 compared with Tramal® for the treatment of moderate to severe pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product DNN.63.18.040 | Experimental | Drug: Product DNN.63.18.040 |
| Tramal® | Active comparator | Drug: Tramal® |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female participants aged 18 years or older and younger than 50 years;
- Underwent extraction of up to 2 impacted third molars requiring bone removal (ostectomy), classified as Pell and Gregory Class II or III and Position B or C;
- Following third molar extraction surgery, experienced moderate to severe pain, defined as a score ≥5 on an 11-point Numeric Rating Scale (NRS), within 5 hours after dental extraction.
Key exclusion criteria (10 listed)
- Surgical duration greater than 4 hours;
- Active inflammatory conditions in the oral cavity due to causes other than inflammation resulting from third molar extraction surgery;
- Any radiologic finding (panoramic dental radiograph) that, in the investigator's opinion, may place the participant at risk if enrolled in the study.
- History or confirmed diagnosis of peptic ulcer disease, gastrointestinal disorders associated with nonsteroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding, or other active bleeding;
- History or confirmed diagnosis of acute or severe bronchial asthma;
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 |
|---|---|---|
| Product DNN.63.18.040One capsule four times daily for 3 days | Drug | Product DNN.63.18.040 |
| Tramal®One capsule four times daily for 3 days | Drug | Tramal® |
Primary outcome
Total Pain Relief Score (TOTPAR6)
Time frame: 6 hours after first dose
Time-weighted sum of pain relief scores over the first 6 hours following the first dose. Pain relief is rated on a scale from 0 (no relief) to 4 (complete relief). TOTPAR6 ranges from 0 to 24, with higher scores indicating greater overall pain relief.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Product DNN.63.18.040 and Tramal® in people with Acute Pain, run by Ache Laboratorios Farmaceuticos S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Total Pain Relief Score (TOTPAR6) (time frame: 6 hours after first dose). 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 19 Oct 2026.