Trial · NCT05683574
Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil
NCT05683574, Phase 3, Withdrawn, Eurofarma Laboratorios S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil. Trials, record NCT05683574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05683574
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil
- NCT number
- NCT05683574
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Conditions
- Third Molar Extraction
- Interventions
- FDC of etoricoxib + cyclobenzaprine + etoricoxib placebo, etoricoxib 90 mg (Arcoxia®) +FDC placebo, cyclobenzaprine hydrochloride + etoricoxib placebo
- First posted
- 2023-01-13
- Last updated
- 2024-02-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary efficacy variable is composed of the sum of the scores for pain relief within 6 h | The primary efficacy variable is an endpoint composed of the sum of pain relief scores within 6 hours and the percentage of postoperative mouth opening. | The primary efficacy variable is composed of the sum of the scores for pain relief within 6 hours and the percentage of postoperative mouth opening. After administration of the first dose, participants will rate pain relief on a 5-point categorical scale at hourly intervals (1 hour, 2 hours, 3 hours, 4 hours, 5 hours and 6 hours). Clinical success is defined as very relief (scale 3) or complete relief (scale 4) within 6 hours after treatment administration. |
| Primary | Primary Efficacy Endpoint - Mouth opening will be calculated from the average of three measurements | Clinical success in this variable is defined as a mouth opening ≥ 80% in relation to the preoperative period. | Mouth opening will be calculated from the average of three measurements that will be taken twice at the randomization visit and at visit 1, the evaluation visit, after three days. The measurement will be made using a calibrated digital caliper, considering the distance between upper and lower central incisors. The percentage of mouth opening at the evaluation visit will be calculated in reference to the baseline opening observed at the randomization visit. Clinical success in this variable is defined as a mouth opening ≥ 80% compared to the preoperative period. |
| Secondary | Secondary Efficacy Endpoints - Proportion of patients reporting much relief or complete relief in TOTPAR question items within 6 hours | Proportion of patients reporting much relief or complete relief in TOTPAR question items within 6 hours. | The two clinical success criteria, defined as components of the primary endpoint, will be described as secondary endpoints: Proportion of patients reporting much relief or complete relief in TOTPAR question items within 6 hours. |
| Secondary | Secondary Efficacy Endpoints - Proportion of patients who maintained at least 80% of full mouth opening three days after the procedure | Proportion of patients who maintained at least 80% of full mouth opening three days after the procedure. | Proportion of patients who maintained at least 80% of full mouth opening three days after the procedure. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05683574
GET https://conductscience.org/api/trials/v1/NCT05683574/registered