Delving into the Latest Updates on Dexketoprofen Trometamol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Arveles, Desketo, Dexketoprofen

+ [23]

Target

COX-1 x COX-2

Mechanism

COX-1 inhibitors(Cyclooxygenase-1 inhibitors), COX-2 inhibitors(Cyclooxygenase-2 inhibitors)

Therapeutic Areas

Nervous System Diseases

Active Indication

Pain, PostoperativeMigraine DisordersPain+ [3]

Inactive Indication

AnalgesiaColicModerate pain+ [1]

Originator Organization

Huangshi Shixing Pharmaceutical Co., Ltd.

Active Organization

Huangshi Shixing Pharmaceutical Co., Ltd.

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Shanxi Pude Pharmaceutical Co., Ltd.

+ [2]

Inactive Organization

Germany Berlin Chemical Co., Ltd. Beijing Office

Guangzhou Yongzheng Pharmaceutical Co.,Ltd.

A. Menarini Industrie Farmaceutiche Riunite SRL

Drug Highest PhaseApproved

First Approval Date

CN (27 Oct 2006),

Migraine DisordersPain

Regulation-

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Structure/Sequence

Molecular FormulaC16H14O3

InChIKeyDKYWVDODHFEZIM-NSHDSACASA-N

CAS Registry22161-81-5

Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration.
The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (dexketoprofen) affects on postoperative pain, swelling and open mouth limitation according the circadian clock

Start Date01 Nov 2024

Sponsor / Collaborator

Universidad Complutense de Madrid

[+1]

ChiCTR2400087079

/ SuspendedPhase 4IIT

Effect of sufentanil combined with dexketoprofen tromethamine in postoperative patient-controlled intravenous analgesia in patients undergoing thoracoscopic surgery

Start Date20 Jul 2024

Sponsor / Collaborator-

CTR20240807

/ RecruitingPhase 3

评价右酮洛芬氨丁三醇注射液治疗术后疼痛的有效性和安全性的随机、双盲、安慰剂平行对照、多中心的Ⅲ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of dexketoprofen tromethamine injection in the treatment of postoperative pain

主要目的：评价右酮洛芬氨丁三醇注射液治疗腹部及骨科手术术后疼痛的有效性。次要目的：评价右酮洛芬氨丁三醇注射液治疗腹部及骨科手术术后疼痛的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of dexketoprofen tromethamine injection in the treatment of postoperative pain after abdominal and orthopedic surgery. Secondary objective: To evaluate the safety of dexketoprofen tromethamine injection in the treatment of postoperative pain after abdominal and orthopedic surgery.

Start Date24 Apr 2024

Sponsor / Collaborator

Shanxi Pude Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Dexketoprofen Trometamol

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100 Translational Medicine associated with Dexketoprofen Trometamol

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100 Patents (Medical) associated with Dexketoprofen Trometamol

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486

Literatures (Medical) associated with Dexketoprofen Trometamol

01 Oct 2024·BMJ Open

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study

Article

Author: Raju, Gopinathan ; Eufemio, Edgar Michael ; Ho, Kok Yuen ; Roohi, Sharifah Ahmad ; Dimayuga, Cesar ; Waithayayothin, Kritsadakorn ; Sawaddiruk, Passakorn ; Gupta, Ankur ; Chong, Keen Wai ; Castro, Marc Anthony L ; Bernardo, Edwin ; Wilairatana, Vajara ; Oon, Zhi Hao ; Nagrale, Dinesh ; Tangwiwat, Suwimon ; Salvador, Roehl C ; Gyanwali, Bibek ; Ona, Leonardo

ObjectivesThis study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.DesignReal-world, prospective, multicentre, observational, phase IV study.Setting13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.ParticipantsAdult patients aged 18–80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.Main outcome measuresPrimary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).ResultsAmong 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.ConclusionThis study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

01 Sep 2024·Heliyon

Immune modulation by dexketoprofen trometamol, a selective eicosanoid biosynthesis inhibitor of cellular immune response and phenoloxidase reaction in response to viral infection in Pimpla turionellae adults

Article

Author: Çelik, Cihat

Nodulation is the first immune defence mechanism related to melanisation in response to microbial infections in insects. Adult parasitoid insects have been hypothesised to produce nodules with melanisation in response to viral infections and, eicosanoids, to mediate nodulation reactions and phenoloxidase (PO) activation in this type of infections. To test this hypothesis, endoparasitoid Pimpla turionellae adults were first inoculated with a novel generation nonsteroidal anti-inflammatory drug (NSAID) dexketoprofen trometamol (DT) (5 μg/adult), which is a selective cyclooxygenase-1 (COX-1) inhibitor. These adults were then immediately injected with intrahaemocoelic injection of Bovine herpes simplex virus-1 (BHSV-1) as a model insect-virus interaction. Additionally, adults were fed on artificial diet with increasing concentrations of DT (0.001, 0.01, or 0.1 g/100 ml diet) per os prior to intrahaemocoelic injection of BHSV-1 (2 × 10³ PFU/adult) and nodulation and PO activity were recorded at 2 h post inoculation (PI). BHSV-1-treated newly emerged adults fed with inhibitors showed low levels of nodulation and increased PO enzyme activity. DT-treated Pimpla adults produced significantly fewer nodules (approximately nine nodules/adult), whereas viral infection provoked nodules (approximately 33 nodules/adult) in comparison with needle (vehicle)-treated controls (approximately five nodules/adult). Increasing dietary dexketoprofen trometamol concentrations decreased nodulation (by 12-fold at the highest concentration) and increased PO reactions (by approximately 3-fold at the highest concentration) to BHSV-1 injection. Compared with control adults, adults orally fed on the lowest DT concentration (0.001 %) significantly increased PO activity (1.22 ± 0.23-2.74 ± 0.31 unit/min/mg protein) while nodules significantly decreased (43.19 ± 4.26-17.84 ± 2.19) in response to virus infections. These findings suggest that eicosanoid biosynthesis, at least in the context of prostaglandins (PGs) formed by COX-1, mediates nodulation reactions and PO activation in response to viral infection in adults of this endoparasitoid. This is the first demonstration that the immune response of P. turionellae adults to viral pathogens is modulated by DT, which initiates haemolymph PO activation.

01 Aug 2024·European Journal of Trauma and Emergency Surgery

Comparison of analgesic efficacy of ibuprofen and dexketoprofen in pain management of long bone fractures: a prospective, randomized, double-blind study

Article

Author: Akbas, İlker ; Kaya, Bekir ; Dönmez, Safa ; Sener, Alp ; Yenal, Kadir ; Ishak Isık, Nurullah

INTRODUCTIONLong bone fractures (LBF) often cause severe pain, impacting patients' quality of life. This prospective, randomized, double-blind study aimed to compare the analgesic efficacy of dexketoprofen (Dex) and ibuprofen (Ibu) in LBF patients in the emergency department.METHODSConducted between August 10, 2023, and January 17, 2024, the study included 100 eligible patients randomized into Dex and Ibu groups. Visual analog scale (VAS) scores were measured at baseline and at 30, 60, and 120 min. DeltaVAS (ΔVAS) values and ΔVAS percentages (ΔVAS%) were calculated. Primary endpoints were ΔVAS scores (ΔVAS 30-60-120) and ΔVAS% for comparative analysis.RESULTSStatistical analysis showed no significant difference in ΔVAS30 (p = 0.359). However, ΔVAS60 exhibited a significant difference (p = 0.027), as did ΔVAS120 (p = < 0.001). ΔVAS%30 showed no significance (p = 0.224), but ΔVAS%60 and ΔVAS%120 were clinically and statistically significant (p = 0.017 and p = < 0.001, respectively).CONCLUSIONIbuprofen 800 mg demonstrated superior analgesic efficacy at 60 and 120 min compared to Dex in long bone fractures. These findings suggest ibuprofen's potential as an effective pain management option in emergency departments.

100 Deals associated with Dexketoprofen Trometamol

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Dexketoprofen Trometamol	M02AA27 M01AE17	DB09214

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain, Postoperative	CN	Nanjing Zenkom Pharmaceutical Co., Ltd.	29 May 2023
Migraine Disorders	CN	Huangshi Shixing Pharmaceutical Co., Ltd.	27 Oct 2006
Pain	CN	Huangshi Shixing Pharmaceutical Co., Ltd.	27 Oct 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Pain	Phase 3	CN	Jiangsu Nhwa Pharmaceutical Co., Ltd.	02 Nov 2023
Analgesia	Preclinical	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	16 Oct 2015
Moderate pain	Preclinical	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	16 Oct 2015
Severe pain	Preclinical	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	16 Oct 2015
Colic	Discovery	CN	Guangzhou Yongzheng Pharmaceutical Co.,Ltd.	27 Dec 2018
Low Back Pain	Discovery	CN	Guangzhou Yongzheng Pharmaceutical Co.,Ltd.	27 Dec 2018
Back Pain	Discovery	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	15 Jul 2015
Pain, Postoperative	Discovery	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	15 Jul 2015
Renal Colic	Discovery	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	15 Jul 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05001555 (Pubmed \| Clin Drug Investig)	Phase 3	-	-	Dexketoprofen 25 mg/Vitamin B (Thiamine 100 mg, Pyridoxine 50 mg, Cyanocobalamin 0.50 mg) FDC	dymbuvjygv(zkzutuuyud) = adwdjnrppi zbnzsbmckq (xeolwhmhll, 2.5 - 10.5)	Positive	01 Jun 2024
				Dexketoprofen 25 mg	dymbuvjygv(zkzutuuyud) = lzrxvmjsnm zbnzsbmckq (xeolwhmhll, 5.0 - 13.8)
NCT01902134 \| EUCTR2012-004548-31-CZ (Pubmed \| Br J Anaesth)	Phase 3	Severe pain \| Moderate pain	641	Dexketoprofen/tramadol 25 mg/75 mg	krzhshnkky(gsyteuwdtp): P-Value = 0.019	Positive	01 Feb 2016
				Dexketoprofen 25 mg
NCT02159547 (CTgov)	Phase 4	Migraine Disorders	224	Dexketoprofen (Dexketoprofen)	otsuagetmq(egcqvubzsg) = dsyfevnwar ufjveqlset (oxychratxz, juvafgwhvm - fqyxxqahrt) View more	-	23 Jul 2015
				Normal Saline (Normal Slaline)	otsuagetmq(egcqvubzsg) = avoiczbwnb ufjveqlset (oxychratxz, ughnkurtjx - olkodpwxby) View more
NCT01730326 (Pubmed \| Emerg Med J)	Phase 4	Acute migraine	200	Intravenous paracetamol	refpupmuhy(hpkganshau) = hvyvevvexg udehdsewva (cnhtrcojvm, 30 - 78.5)	-	01 Mar 2014
				Dexketoprofen	refpupmuhy(hpkganshau) = pvpjmzhhky udehdsewva (cnhtrcojvm, 34 - 75)