Clinical trial to evaluated the efficacy and safety of Maxsulid® (Cosmed) compared to Nisulid® (Aché) medicine in the treatment of postoperative pain of wisdom teeth extraction.

No inferiority Phase III clinical trial, randomized, multicentre, parallel and blind to evaluated the efficacy and safety of Maxsulid® (Cosmed) compared to Nisulid® (Aché) medicine in the treatment of postoperative pain of third molar extraction.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-73gfct

Enrollment

Unknown

Registered

2019-02-12

Start date

2019-06-30

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post operative pain of third molar extration.

Interventions

336 participants will be recruited (168 participants for the test group and 168 participants for the comparative group). Both products will be used in a single dose orally in the research center. The

Drug

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Sign the Informed Consent approved by the Ethics Committee,age greater than or equal 18 years old, participants of both sexes, have a third molar removal dental surgery in the last few hours and have a pain assessment on the VAS scale at least 50 mm.

Exclusion criteria

Exclusion criteria: Have used anti-inflammatories or analgesics of any nature in the last 48 hours; Have a history of peptic ulcer or gastrointestinal bleeding; Illness of any nature that contraindicates participation in the study; Is not able to understand and perform the pain assessments present in the study; Hypersensitivity or contraindication known to the medications or components of the medications studied; Pregnant or lactating women; Professionals and their relatives who are directly involved in the process during this study; Participation in another study in less than one year.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study will be the improvement of pain intensity by Visual Analogue Scale (VAS) 15 minutes after the study medication was taken.	—

Secondary

Measure	Time frame
Expected outcome 1: Assessment of pain intensity by the Visual Analogue Scale (VAS) at times 30, 45, 60, 90, 120, 180, 240, and 360 minutes after the first study medication was taken. ;Expected outcome 2: Assessment of 5-point pain relief rating scale (0 for no pain relief, 1 for discrete relief, 2 for moderate relief, 3 for very good relief, 4 for complete pain relief) at times 30, 45, 60, 90, 120, 180, 240, and 360 minutes after the first study medication was taken. ;Expected outcome 3: Assessment of time taken for the rescue medication (if necessary).;Expected outcome 4: The overall evaluation of the treatment by the participant and the investigator. ;Expected outcome 5: Evaluation of the presence of adverse events.	—

Measure

Time frame

Expected outcome 1: Assessment of pain intensity by the Visual Analogue Scale (VAS) at times 30, 45, 60, 90, 120, 180, 240, and 360 minutes after the first study medication was taken. ;Expected outcome 2: Assessment of 5-point pain relief rating scale (0 for no pain relief, 1 for discrete relief, 2 for moderate relief, 3 for very good relief, 4 for complete pain relief) at times 30, 45, 60, 90, 120, 180, 240, and 360 minutes after the first study medication was taken. ;Expected outcome 3: Assessment of time taken for the rescue medication (if necessary).;Expected outcome 4: The overall evaluation of the treatment by the participant and the investigator. ;Expected outcome 5: Evaluation of the presence of adverse events.

—

Countries

Brazil

Contacts

Public ContactAndrea;Rafaela Rigo;Mendes Pavlovsky

CEMEC (Centro Multidiciplinar de Estudos Clínicos);CEMEC (Centro Multidiciplinar de Estudos Clínicos)

ctdfb@uol.com.br;rodrigo.pavani@cemecpesquisaclinica.com+55-011-4930-4243;(11) 4317 6051

Outcome results

None listed

Source: REBEC (via WHO ICTRP)