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.

Start Date30 May 2026

Sponsor / Collaborator

Eurofarma Laboratórios SA

NCT05118672

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Parallel-group, Double-blind, Comparative Trial of the Superiority of Paracetamol 500mg/Fexofenadine 60mg/Phenylephrine 20mg Fixed-dose Combination Versus Placebo in the Symptomatic Treatment of Flu and Cold

A Phase 3, multicenter, Randomized, Double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + Fexofenadine 60mg + Phenylephrine 20mg in the flu and common cold treatment.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Start Date30 Nov 2024

Sponsor / Collaborator

Eurofarma Laboratórios SA

NCT03792295

/ WithdrawnPhase 2

The Effect of Multimodal Pain Therapy After Hernia Repair

Investigating the effect of multimodal pain treatment after hernia repair

Start Date01 Jul 2021

Sponsor / Collaborator-

100 Clinical Results associated with α-adrenergic receptor x COX x Histamine receptor

100 Translational Medicine associated with α-adrenergic receptor x COX x Histamine receptor

0 Patents (Medical) associated with α-adrenergic receptor x COX x Histamine receptor

Literatures (Medical) associated with α-adrenergic receptor x COX x Histamine receptor

01 Apr 2021·British Journal of DermatologyQ1 · MEDICINE

An additional drug repurposing study for hidradenitis suppurativa/acne inversa

Q1 · MEDICINE

Letter

Author: Readhead, B. ; Dudley, J.T. ; Zouboulis, C.C.

Current transcriptome and proteome studies have identified differentially regulated genes and proteins in hidradenitis suppurativa/acne inversa (HS), both in entire involved skin and in involved skin apocrine glands.In this report, we provide addnl. information obtained by further anal. of our data using mol. drug information available through chemogenomic studies.Raw microarray profiles from our own previous studies downloaded from Gene Expression Omnibus (GSE137141) and (GSE144801) were used in this study.The data for anal. originated from whole lesional skin (LS) and nonlesional skin (NLS) of 28 European patients [20 female, eight male; aged 35.0 (10.2) years] with active HS Hurley stage II-III and healthy skin (CS) of 12 matched controls [aged 37.1 (13.2) years].The comparison of LS vs. NLS revealed several new drug target genes, namely ABAT, ADH1C, ADIRF, ADRA1A, ANDR, CFD, CHRM1, CLEC3B, CP3A4, DACB, DRD1, DRD5, GABBR1, GBP6, GBRA6, GBRR1, GCR, GPD1, GRIA1, GRM4, HRH1, IF4H, KRT6B, LPA, MCR, MRCA, MRCB, OPRD, OPRM, PA24A, PBPC, PLAT, PLG, PRKAB1, PTGS1, PTGS2, RPL38, SLC6A4, TA2R, TBXA2R, THAS, TLR2 and UTS2, in addition to the ones detected as HS biomarkers in our previous study, namely DEFB4A/ DEFB4B, GJB2, KRT6A, KRT16, MMP1, MMP9, PI3, S100A7A, S100A8, S100A9, S100A12, SERPINB3, SERPINB4 and SPRR3.Therefore, repurposing drugs may become future targets of investigator-initiated studies supported from peer-reviewed public funding sources.

01 Jun 1993·The Journal of pharmacology and experimental therapeutics

Endothelium- and beta-2 adrenoceptor-independent relaxation of rat aorta by tyramine and certain other phenylethylamines.

Article

Author: Chemtob, S ; Varma, D R

At concentrations higher than that required to produce maximal vasoconstriction, tyramine caused concentration-dependent relaxation of rat aortic strips contracted maximally by tyramine, norepinephrine, phenylephrine, 5-hydroxytryptamine, prostaglandin F2 alpha, endothelin, angiotensin II and potassium; isoproterenol did not relax potassium-contracted strips. The vasorelaxant effect of tyramine was not antagonized by propranolol, pindolol or nadolol, all of which markedly antagonized the effects of isoproterenol. The vasorelaxant activity of tyramine was endothelium-independent and not inhibited by hemoglobin, methylene blue or L-NG-nitro arginine; it did not exhibit tachyphylaxis and was neither inhibited by cocaine, guanethidine, reserpine and chemical sympathectomy nor by alpha adrenoceptor, dopamine receptor, 5-hydroxytryptamine receptor, histamine receptor and adenosine receptor antagonists. Inhibition of cyclooxygenase, lipoxygenase and monamine oxidase activities did not decrease the vasorelaxant activity of tyramine. The vasorelaxant effect of tyramine was not decreased by altering external calcium from 0.25 to 4 mM nor was it potentiated by nifedipine. Phenylethylamine was the minimum structural requirement for this propranolol-resistant vasorelaxant activity; beta-carbon and 3-ring hydroxylation abolished this activity, but N-methylation partly overcame the effect of beta-hydroxylation. The vasopressor effect of tyramine in anesthetized rat was reversed to vasodepressor effect by phenoxybenzamine plus propranolol. The propranolol-resistant vasorelaxant effect of tyramine was also confirmed on isolated human placenta arteries. At vasorelaxant concentrations, tyramine did not increase cyclic GMP and cyclic AMP but inhibited inositol-1,4,5-triphosphate. It is suggested that at high concentrations tyramine and related phenylethylamines cause endothelium- and beta-2 adrenoceptor independent vasorelaxation either via specific tyramine receptors or nonselectively.

01 Aug 1987·American Review of Respiratory Disease

Enhancement by Parainfluenza 3 Infection of Contractile Responses to Substance P and Capsaicin in Airway Smooth Muscle from the Guinea Pig

Article

Author: Saban, Ricardo ; Fishleder, Rand I. ; Buckner, Carl K. ; Dick, Elliot C.

Guinea pigs were inoculated by nasal insufflation with parainfluenza 3 (P-3) or virus growth medium 4 days before performing in vitro pharmacologic studies on left bronchial ring segments. Cumulative dose-response studies with capsaicin revealed an enhanced contractile response after P-3 infection. The sensitivity and magnitude of contractile effects of substance P in the left bronchi were also enhanced by P-3 infection. After pretreatment of the isolated tissues with phenoxybenzamine to block histamine H1 (with metiamide to block histamine H2), muscarinic, serotonergic, and alpha adrenergic receptors, or indomethacin to block the cyclooxygenase pathway of arachidonic acid metabolism, P-3 remained effective in enhancing contractile responses, even though these pretreatments altered the sensitivity and/or magnitude of contractions produced by substance P. When ETYA or NDGA were combined with indomethacin to also block the lipoxygenase pathway of arachidonic acid metabolism, the sensitizing effect of P-3 infection was diminished or abolished, especially at larger concentrations of substance P. With combination of FPL55712 and indomethacin, the sensitizing effect of P-3 was not abolished. Contractile responses to LTC4 and LTD4 were not enhanced by P-3 infection. The data suggest a selective influence of P-3 infection on the substance P system and provide evidence for a role of the lipoxygenase pathway of arachidonic acid metabolism in the sensitizing action. Peptide leukotrienes do not appear to be the lipoxygenase products involved in this effect of virus.

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