Efficacy and Safety of DNN.63.18.040 for the Treatment of Moderate to Severe Pain

NCT07880392 — Phase 3, Not yet recruiting, 370 participants, Ache Laboratorios Farmaceuticos S.A.

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A Randomized Clinical Trial to Evaluate the Safety and Efficacy of DNN.63.18.040 for the Treatment of Moderate to Severe Pain

Registry	NCT07880392, acronym PIERRE
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	370 (Estimated)
Sponsor	Ache Laboratorios Farmaceuticos S.A. (Industry)
Conditions	Acute Pain
Interventions	Product DNN.63.18.040, Tramal® (Drug)
Dates	start 2026-10-19 (estimated), primary completion 2027-03-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-10-19, last updated 2026-10-19

-Summary

This study evaluates the safety and efficacy of DNN.63.18.040 compared with Tramal® for the treatment of moderate to severe pain.

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+Arms and interventions

Arm	Type	Interventions	Description
Product DNN.63.18.040	Experimental	Drug: Product DNN.63.18.040
Tramal®	Active comparator	Drug: Tramal®

Product DNN.63.18.040 (Drug): One capsule four times daily for 3 days
Tramal® (Drug): One capsule four times daily for 3 days

+Outcome measures

Primary outcomes

Total Pain Relief Score (TOTPAR6) [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.

+Eligibility

Sex: All, ages: 18 Years to 49 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.