Third Molar ExtractionPhase 3BENCOXNCT05683574
Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil
A Phase 3 study of Third Molar Extraction, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Third Molar Extraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 30 May 2026to 28 Feb 2028
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes who meet all of the following criteria will be included in the study:
- Age between 18 and 35 years (inclusive).
- Presence of at least one lower third molar with partial or total bone inclusion (occlusal surface partially or completely covered by bone tissue) with indication for surgical removal (diagnosis made by panoramic radiograph taken within the six [06] months prior to study enrollment), in a vertical, mesioangular or horizontal position according to the Winter classification1,provided they belong to the following Pell \& Gregory classes2:
- Impacted lower third molar in vertical or mesioangular position: may be included, as long as it belongs to Pell \& Gregory classes Ia, Ib, IIa or IIb;
- Lower third molar impacted in a horizontal position: may be included, as long as it belongs to Pell \& Gregory classes Ia, Ib or IIa.
Who cannot join
- Patients who meet at least one of the following criteria will be excluded from the study:
- Presence of previous inflammatory and/or infectious oral lesion with indication for the use of anti-inflammatory agent and/or antibiotic therapy.
- Presence of any oral lesion in the region of the third molar to be extracted that may contraindicate extraction, at the discretion of the dental team (for example, pericoronitis, periodontitis, cysts, among others).
- Smoking* *Any use of tobacco, including e-cigarettes, is prohibited during the study. In the case of the participant who occasionally smokes, he/she must be willing not to use tobacco throughout his/her participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parallel-Group,Double-Blind,Double-Dummy,Superiority Study of Etoricoxib90mg/ Cyclobenzaprine15mg From Eurofarma Versus Etoricoxib90mg (Arcoxia®) and Cyclobenzaprine15mg (XL - Mitrul®) for Muscle Spasm After Third Molar Extraction in Brazil
Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases. Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases.
Read the detailed description
The investigational drug consists of a fixed-dose combination (FDC) that contains etoricoxib, a non-steroidal anti-inflammatory drug (NSAID) with analgesic action, and cyclobenzaprine hydrochloride, a myorelaxant, in doses of 90 mg and 15 mg, respectively, in the dosage form of a prolonged-release hard capsule. This product is an unprecedented FDC in the country, and is indicated for the short-term treatment of moderate to serious acute pain associated with muscle spasm. Pain management with analgesic drugs, such as NSAIDs and other adjuvant drugs, is common in daily clinical practice. In parallel with its additive effect on pain relief, the FDC of an anti-inflammatory and myorelaxant agent seeks to assist in greater control of associated musculoskeletal symptoms, such as inflammatory processes, limited range of motion, and muscle spasms.
Multicenter, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Comparative Superiority clinical trial. Patients aged between 18 and 35 years with indication for surgical removal of an impacted lower third molar and an antagonistic upper third molar will be randomized in a 1:1:1 ratio to receive the FDC of etoricoxib 90 mg + cyclobenzaprine hydrochloride 15 mg from Eurofarma Laboratórios SA (investigational drug), in capsules, or the mono-drugs etoricoxib 90 mg (Arcoxia®), in tablets, or cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®), in capsules, for up to three (03) days. Participants whose surgery lasts a maximum of 80 minutes (counted from the initial incision to the extraction of the third molars) and who present moderate to serious postoperative pain up to a maximum of four (04) hours will be randomized. The first administration of study treatment will be made at the study center when post-surgical pain reaches moderate/serious intensity (≥ 40 mm on visual analogue scale [VAS] 0-100 mm). The participants will be instructed, from then on, to use the study treatment, respecting a minimum interval of twenty-four (24) hours between doses taken for three (03) days.
- Conditions
- Third Molar Extraction
- Being tested
- FDC of etoricoxib + cyclobenzaprine + etoricoxib placebo, etoricoxib 90 mg (Arcoxia®) +FDC placebo, cyclobenzaprine hydrochloride + etoricoxib placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC of etoricoxib + cyclobenzaprine + etoricoxib placeboDrug
Also called Investigation drug 1
Participants randomized to this group will receive one (01) capsule of the investigational drug and one (01) etoricoxib placebo tablet, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.
etoricoxib 90 mg (Arcoxia®) +FDC placeboDrug
Also called Comparator drug 2
Participants randomized to this group will receive one (01) etoricoxib 90 mg tablet (Arcoxia®) and one (01) FDC placebo capsule, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.
cyclobenzaprine hydrochloride + etoricoxib placeboDrug
Also called Comparator drug 3
Participants randomized to this group will receive one (01) cyclobenzaprine hydrochloride 15 mg capsule (XL - Mitrul®) and one (01) etoricoxib placebo tablet, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| etoricoxib 90 mg + cyclobenzaprine 15 mg | Experimental | Investigational group: FDC of etoricoxib 90 mg + cyclobenzaprine 15 mg from Eurofarma Laboratórios SA Receives: Drug: FDC of etoricoxib + cyclobenzaprine + etoricoxib placebo |
| etoricoxib 90 mg | Active comparator | Comparator group: etoricoxib 90 mg (Arcoxia®) Receives: Drug: etoricoxib 90 mg (Arcoxia®) +FDC placebo |
| cyclobenzaprine hydrochloride 15 mg | Active comparator | Comparator group: cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) Receives: Drug: cyclobenzaprine hydrochloride + etoricoxib placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy variable is composed of the sum of the scores for pain relief within 6 h
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.
Measured: 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.
Primary Efficacy Endpoint - Mouth opening will be calculated from the average of three measurements
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.
Measured: Clinical success in this variable is defined as a mouth opening ≥ 80% in relation to the preoperative period.
Secondary outcomes (2)
Secondary Efficacy Endpoints - 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.
Measured: Proportion of patients reporting much relief or complete relief in TOTPAR question items within 6 hours.
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.
Measured: Proportion of patients who maintained at least 80% of full mouth opening three days after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start30 May 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Why it stopped: Change in study strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar ExtractionStudies 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
- Model description
- Participants who meet all eligibility criteria will be randomized to one of the following treatment groups: Investigational group: FDC of etoricoxib 90 mg + cyclobenzaprine 15 mg from Eurofarma Laboratórios SA (investigational drug). Participants randomized to this group will receive one (01) capsule of the investigational drug when postoperative pain intensity reaches moderate to serious intensity (≥ 40 mm at VAS 0-100 mm) and one (01) etoricoxib placebo tablet. The participants will be instructed, from then on, to use this same treatment, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683574
- Sponsor's protocol ID
- EF 181
- Acronym
- BENCOX
- Status last verified
- Jan 2024
- First submitted
- 1 Dec 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel-Group,Double-Blind,Double-Dummy,Superiority Study of Etoricoxib90mg/ Cyclobenzaprine15mg From Eurofarma Versus Etoricoxib90mg (Arcoxia®) and Cyclobenzaprine15mg (XL - Mitrul®) for Muscle Spasm After Third Molar Extraction in Brazil
- ClinicalTrials.gov ID
- NCT05683574
- Acronym / sponsor ID
- BENCOX / EF 181
- Conditions
- Third Molar Extraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 13 Jan 2023 (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.
Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases. Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases.
Detailed description
The investigational drug consists of a fixed-dose combination (FDC) that contains etoricoxib, a non-steroidal anti-inflammatory drug (NSAID) with analgesic action, and cyclobenzaprine hydrochloride, a myorelaxant, in doses of 90 mg and 15 mg, respectively, in the dosage form of a prolonged-release hard capsule. This product is an unprecedented FDC in the country, and is indicated for the short-term treatment of moderate to serious acute pain associated with muscle spasm. Pain management with analgesic drugs, such as NSAIDs and other adjuvant drugs, is common in daily clinical practice. In parallel with its additive effect on pain relief, the FDC of an anti-inflammatory and myorelaxant agent seeks to assist in greater control of associated musculoskeletal symptoms, such as inflammatory processes, limited range of motion, and muscle spasms.
Multicenter, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Comparative Superiority clinical trial. Patients aged between 18 and 35 years with indication for surgical removal of an impacted lower third molar and an antagonistic upper third molar will be randomized in a 1:1:1 ratio to receive the FDC of etoricoxib 90 mg + cyclobenzaprine hydrochloride 15 mg from Eurofarma Laboratórios SA (investigational drug), in capsules, or the mono-drugs etoricoxib 90 mg (Arcoxia®), in tablets, or cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®), in capsules, for up to three (03) days. Participants whose surgery lasts a maximum of 80 minutes (counted from the initial incision to the extraction of the third molars) and who present moderate to serious postoperative pain up to a maximum of four (04) hours will be randomized. The first administration of study treatment will be made at the study center when post-surgical pain reaches moderate/serious intensity (≥ 40 mm on visual analogue scale [VAS] 0-100 mm). The participants will be instructed, from then on, to use the study treatment, respecting a minimum interval of twenty-four (24) hours between doses taken for three (03) days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Participants who meet all eligibility criteria will be randomized to one of the following treatment groups: Investigational group: FDC of etoricoxib 90 mg + cyclobenzaprine 15 mg from Eurofarma Laboratórios SA (investigational drug). Participants randomized to this group will receive one (01) capsule of the investigational drug when postoperative pain intensity reaches moderate to serious intensity (≥ 40 mm at VAS 0-100 mm) and one (01) etoricoxib placebo tablet. The participants will be instructed, from then on, to use this same treatment, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.
| Arm | Type | Receives |
|---|---|---|
| etoricoxib 90 mg + cyclobenzaprine 15 mg | Experimental | Drug: FDC of etoricoxib + cyclobenzaprine + etoricoxib placeboInvestigational group: FDC of etoricoxib 90 mg + cyclobenzaprine 15 mg from Eurofarma Laboratórios SA |
| etoricoxib 90 mg | Active comparator | Drug: etoricoxib 90 mg (Arcoxia®) +FDC placeboComparator group: etoricoxib 90 mg (Arcoxia®) |
| cyclobenzaprine hydrochloride 15 mg | Active comparator | Drug: cyclobenzaprine hydrochloride + etoricoxib placeboComparator group: cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of both sexes who meet all of the following criteria will be included in the study:
- Age between 18 and 35 years (inclusive).
- Presence of at least one lower third molar with partial or total bone inclusion (occlusal surface partially or completely covered by bone tissue) with indication for surgical removal (diagnosis made by panoramic radiograph taken within the six [06] months prior to study enrollment), in a vertical, mesioangular or horizontal position according to the Winter classification1,provided they belong to the following Pell \& Gregory classes2:
Key exclusion criteria (4 listed)
- Presence of previous inflammatory and/or infectious oral lesion with indication for the use of anti-inflammatory agent and/or antibiotic therapy.
- Presence of any oral lesion in the region of the third molar to be extracted that may contraindicate extraction, at the discretion of the dental team (for example, pericoronitis, periodontitis, cysts, among others).
- Smoking* *Any use of tobacco, including e-cigarettes, is prohibited during the study. In the case of the participant who occasionally smokes, he/she must be willing not to use tobacco throughout his/her participation in the study.
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 |
|---|---|---|
| FDC of etoricoxib + cyclobenzaprine + etoricoxib placeboAlso: Investigation drug 1Participants randomized to this group will receive one (01) capsule of the investigational drug and one (01) etoricoxib placebo tablet, respecting a minimum interval of twenty-four (24) hours between doses for 3 days. | Drug | etoricoxib 90 mg + cyclobenzaprine 15 mg |
| etoricoxib 90 mg (Arcoxia®) +FDC placeboAlso: Comparator drug 2Participants randomized to this group will receive one (01) etoricoxib 90 mg tablet (Arcoxia®) and one (01) FDC placebo capsule, respecting a minimum interval of twenty-four (24) hours between doses for 3 days. | Drug | etoricoxib 90 mg |
| cyclobenzaprine hydrochloride + etoricoxib placeboAlso: Comparator drug 3Participants randomized to this group will receive one (01) cyclobenzaprine hydrochloride 15 mg capsule (XL - Mitrul®) and one (01) etoricoxib placebo tablet, respecting a minimum interval of twenty-four (24) hours between doses for 3 days. | Drug | cyclobenzaprine hydrochloride 15 mg |
Primary outcome
Primary efficacy variable is composed of the sum of the scores for pain relief within 6 h
Time frame: 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 Efficacy Endpoint - Mouth opening will be calculated from the average of three measurements
Time frame: 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.
2 secondary outcomes
Secondary Efficacy Endpoints - Proportion of patients reporting much relief or complete relief in TOTPAR question items within 6 hours
Time frame: Proportion of patients reporting much relief or complete relief in TOTPAR question items within 6 hours.
Secondary Efficacy Endpoints - Proportion of patients who maintained at least 80% of full mouth opening three days after the procedure
Time frame: Proportion of patients who maintained at least 80% of full mouth opening three days after the procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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 of Third Molar Extraction, run by Eurofarma Laboratorios 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?
The sponsor lists 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Feb 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary efficacy variable is composed of the sum of the scores for pain relief within 6 h (time frame: 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 study lists 2 primary outcomes in all. 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 28 Feb 2024.