Third Molar Extraction Clinical Trial
— BENCOXOfficial 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
Verified date | January 2024 |
Source | Eurofarma Laboratorios S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 28, 2028 |
Est. primary completion date | October 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Eurofarma Laboratorios S.A | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Eurofarma Laboratorios S.A. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | 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. | Clinical success in this variable is defined as a mouth opening = 80% in relation to the preoperative period. | |
Secondary | 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. |
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. |
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