Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05683574
Status:
WITHDRAWN
Last Update Posted:
2024-02-28
First Post:
2022-12-01
Brief Title:
Fixed-dose Combination of Etoricoxib Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
Parallel-GroupDouble-BlindDouble-DummySuperiority Study of Etoricoxib90mg Cyclobenzaprine15mg From Eurofarma Versus Etoricoxib90mg Arcoxia and Cyclobenzaprine15mg XL - Mitrul for Muscle Spasm After Third Molar Extraction in Brazil
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in study strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BENCOX
Brief 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 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 111 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 moderateserious 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
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 111 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 moderateserious 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None