右酮洛芬氨丁三醇/盐酸曲马多(Dexketoprofen Trometamol/Tramadol Hydrochloride) - 药物靶点：COX-1 x COX-2 x μ opioid receptor_在研适应症：急性疼痛_专利_临床

概要

基本信息

药物类型

小分子化药

别名

DKP.TRIS/TRAM、DKP.TRIS/TRAM.HCL、DKP/TRAM

+ [11]

靶点

COX-1 x COX-2 x μ opioid receptor

作用方式

抑制剂、激动剂

作用机制

COX-1抑制剂(环氧化酶-1抑制剂)、COX-2抑制剂(环氧化酶-2抑制剂)、μ opioid receptor激动剂(μ-阿片受体激动剂)

治疗领域

神经系统疾病其他疾病

在研适应症

急性疼痛

非在研适应症

术后疼痛

原研机构

A. Menarini Industrie Farmaceutiche Riunite Srl

在研机构

Menarini Ricerche SpA

A. Menarini Industrie Farmaceutiche Riunite Srl

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

西班牙 (2015-12-20),

急性疼痛

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C16H26ClNO2

InChIKeyPPKXEPBICJTCRU-NDFJEYLFSA-N

CAS号36282-47-0

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关联

7

项与右酮洛芬氨丁三醇/盐酸曲马多相关的临床试验

NCT05170841

/ Completed临床4期

Randomized, Double-blind, Placebo-controlled, Parallel Arm Group Study Evaluating Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride on Moderate to Severe Acute Pain in Patients With Acute Low Back Pain

A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain.

开始日期2020-09-17

申办/合作机构

Menarini International Operations Luxembourg SA

NCT04178109

/ Completed临床2期IIT

EVALUATION OF ORAL USE OF DEXKETOPROFEN/TRAMADOL IN ACUTE POSTOPERATIVE PAIN IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH A MINIMALLY INVASIVE ANTERIOR APPROACH (AMIS).

Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).

开始日期2019-01-10

申办/合作机构-

NCT02777970

/ Completed临床4期

Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar (Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study)

The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.

开始日期2016-04-01

申办/合作机构

A. Menarini Industrie Farmaceutiche Riunite Srl

100 项与右酮洛芬氨丁三醇/盐酸曲马多相关的临床结果

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100 项与右酮洛芬氨丁三醇/盐酸曲马多相关的转化医学

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100 项与右酮洛芬氨丁三醇/盐酸曲马多相关的专利（医药）

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4

项与右酮洛芬氨丁三醇/盐酸曲马多相关的文献（医药）

2024-08-01·Pain and Therapy

Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE)

Article

作者: Coaccioli, Stefano ; Hanna, Magdi ; Kruljac, Ivan ; Varrassi, Giustino ; Fabrizzi, Paolo ; Brotons, Carles ; Baldini, Simone ; Perrot, Serge

INTRODUCTIONDexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE).METHODSA total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61).RESULTSThe proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated.CONCLUSIONAlthough the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP.DANTE STUDY REGISTRATIONEudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.

2024-03-01·BMJ Open

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Article

作者: Raju, Gopinathan ; Eufemio, Edgar Michael ; Ho, Kok Yuen ; Roohi, Sharifah Ahmad ; Dimayuga, Cesar ; Waithayayothin, Kritsadakorn ; Gupta, Ankur ; Sawaddiruk, Passakorn ; 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

IntroductionSatisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.Methods and analysisREKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.Ethics and disseminationThe study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

2018-06-01·Drug and Therapeutics Bulletin

What place is there for tramadol/dexketoprofen?

Article

No single analgesic provides effective pain relief in all patients and increasing the dose of an analgesic may increase its unwanted effects.1 In addition, pain frequently results from multiple mechanisms that may respond to different pharmacological interventions.2 One suggested approach is to combine analgesics with different modes of action, with the aim of delivering better analgesia using lower doses of each drug.1 Skudexa (A. Menarini Farmaceutica Internazionale SRL), a combination of tramadol hydrochloride (a synthetic opioid analgesic that is a partial agonist at the μ, δ and κ opioid receptors) and dexketoprofen (a NSAID), is licensed for short term treatment of moderate to severe acute pain in adults.1-4 Here, we consider the evidence for this product and how it fits with current guidance on the management of pain.

100 项与右酮洛芬氨丁三醇/盐酸曲马多相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M02AA27 M01AE17	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性疼痛	西班牙	Menarini Ricerche SpA	2015-12-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
术后疼痛	临床前	拉脱维亚	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	德国	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	波兰	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	塞尔维亚	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	乌克兰	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	匈牙利	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	中国台湾	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	捷克	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	西班牙	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01
术后疼痛	临床前	立陶宛	A. Menarini Industrie Farmaceutiche Riunite Srl	2013-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02777970 (DAVID, CTgov)	临床4期	急性疼痛	654	Placebo+Tramadol Hydrochloride/Dexketoprofen Trometamol (Tramadol/Dexketoprofen)	鬱壓網衊齋窪簾簾範鏇(鏇憲構壓網鹽艱鬱選鹹) = 襯積齋構餘窪願膚壓築餘蓋襯窪鹽遞鏇廠鏇壓 (顧壓窪範鑰願選顧鹽膚, 鏇膚憲範壓簾鑰餘醖淵 ~ 範範餘齋築鹹襯夢齋願) 更多	-	2021-03-24
				Placebo+Tramadol Hydrochloride/Paracetamol (Tramadol/Paracetamol)	鬱壓網衊齋窪簾簾範鏇(鏇憲構壓網鹽艱鬱選鹹) = 顧蓋窪獵餘觸憲壓齋製餘蓋襯窪鹽遞鏇廠鏇壓 (顧壓窪範鑰願選顧鹽膚, 膚憲鏇憲鏇壓鹽範鹹窪 ~ 膚衊觸鹽簾壓齋夢淵膚) 更多
NCT01902134 \| EUCTR2012-004548-31-CZ (Pubmed \| Br J Anaesth)	临床3期	重度疼痛 \| 中度疼痛	641	Dexketoprofen/tramadol 25 mg/75 mg	網餘廠觸遞襯願積淵選(糧淵遞襯獵繭齋淵憲淵): P-Value = 0.019	积极	2016-02-01
				Dexketoprofen 25 mg
NCT01902134 (DAVID-art, CTgov)	临床3期	急性疼痛 \| 术后疼痛	641	Dexketoprofen/Tramadol-single dose (DKP/TRAM Followed by DKP/TRAM)	鑰齋鹽鹽醖築鑰範網衊(廠積願鏇鹽鬱齋艱夢窪) = 壓齋製觸鹽繭艱衊衊鬱淵糧構鏇鏇製鏇壓顧遞 (獵襯壓範淵廠構鹽鹽積, 壓選遞觸窪鹽襯築窪願 ~ 糧鬱築齋築糧壓醖膚蓋) 更多	-	2015-04-01
				Dexketoprofen-single dose (DKP Followed by DKP)	鑰齋鹽鹽醖築鑰範網衊(廠積願鏇鹽鬱齋艱夢窪) = 選觸範壓襯鏇餘壓膚壓淵糧構鏇鏇製鏇壓顧遞 (獵襯壓範淵廠構鹽鹽積, 觸窪獵鹽膚衊膚窪餘網 ~ 遞蓋艱醖餘襯壓鹹憲簾) 更多
NCT01904149 (DAVID lap, CTgov)	临床3期	急性疼痛 \| 术后疼痛	606	Dexketoprofen/Tramadol-single dose (DKP/TRAM Followed by DKP/TRAM)	觸夢糧窪製繭鬱顧鑰獵(糧選淵範觸衊範築構醖) = 糧顧選網遞簾齋鏇築鹽繭構蓋衊鹽製顧選願積 (廠選簾鹽範膚廠獵齋繭, 鏇艱網顧鹹壓衊壓艱蓋 ~ 壓鹽壓衊積夢衊構膚憲) 更多	-	2015-04-01
				Dexketoprofen-single dose (DKP Followed by DKP)	觸夢糧窪製繭鬱顧鑰獵(糧選淵範觸衊範築構醖) = 鑰壓窪窪憲選衊鹽鹽觸繭構蓋衊鹽製顧選願積 (廠選簾鹽範膚廠獵齋繭, 窪簾蓋艱衊遞觸顧醖獵 ~ 艱製蓋鬱簾艱憲艱願鹽) 更多