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

在研适应症

急性疼痛

非在研适应症-

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-

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

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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5

项与右酮洛芬氨丁三醇/盐酸曲马多相关的文献（医药）

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 ; 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

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.

2022-09-01·Nigerian Journal of Clinical Practice

Posterior Quadratus Lumborum Block Versus Posterior Transversus Abdominis Plane Block for Unilateral Inguinal Hernia Surgery

Article

作者: Ergil, J ; Altinsoy, S ; Ozhan, M O ; Akelma, F K ; Caparlar, C O

Background:Ultrasound-guided truncal nerve blocks are increasingly used for postoperative pain relief after abdominal surgery.Aim:The aim of this prospective and randomized study was to compare posterior transversus abdominis plane block (pTAPB) with posterior quadratus lumborum block (pQLB) for postoperative analgesic efficacy in patients undergoing unilateral inguinal hernia surgery under general anesthesia (GA).Patients and Methods:A total of 90 adult patients were randomized into 3 groups: group pTAPB (n = 30), group pQLB (n = 30), and group Control (n = 30). The patients in groups pQLB and pTAPB received a unilateral block using 20 ml of 0.25% bupivacaine after the induction of GA. Intravenous (IV) tramadol patient control group analgesia (PCA) and paracetamol were used in the postoperative period as a part of the multimodal analgesic regimen in both groups. Postoperative pain was assessed using a visual analog scale (VAS) during postoperative 24 h. Dexketoprofene was used as a rescue analgesic when VAS is >3. The primary outcome measure was mean pain scores. Secondary outcome measures were consumption of rescue analgesics and the amount of tramadol delivered by PCA. P <0.05 was considered statistically significant.Results:Mean VAS scores were significantly lower in the group pQLB than group pTAPB and group Control at all-time points (pQLB < pTAPB < Control; P < 0.001). Rescue analgesic was not required in group QLB. Rescue analgesic consumption, the number of bolus demand on PCA, and total PCA dose were highest in group Control and lowest in the pQLB group (Control > pTAPB > pQLB; P < 0.001).Conclusion:It is concluded that both pQLB and pTAPB provided effective pain relief after unilateral inguinal hernia surgery. pQLB was superior to pTAPB due to lower pain scores and analgesic consumption.

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

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

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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)	鬱壓鏇繭糧膚壓遞構範(獵蓋憲構選構製糧醖蓋) = 構鏇窪鏇獵壓夢觸餘襯衊壓齋膚艱淵窪範窪憲 (醖製醖選觸鏇築鑰鬱鹹, 醖醖鑰糧壓憲簾鏇膚壓 ~ 衊簾觸憲鏇鑰憲構鹽選) 更多	-	2021-03-24
				Placebo+Tramadol Hydrochloride/Paracetamol (Tramadol/Paracetamol)	鬱壓鏇繭糧膚壓遞構範(獵蓋憲構選構製糧醖蓋) = 顧鹽糧衊窪淵窪遞鏇鹽衊壓齋膚艱淵窪範窪憲 (醖製醖選觸鏇築鑰鬱鹹, 選齋襯顧餘獵衊廠簾網 ~ 繭餘繭遞網獵網鏇壓衊) 更多
NCT01902134 \| EUCTR2012-004548-31-CZ (Pubmed \| Vet Anaesth Analg)	临床3期	重度疼痛 \| 中度疼痛	641	Dexketoprofen/tramadol 25 mg/75 mg	衊艱蓋鬱鑰築願廠構網(餘醖鑰淵襯夢願蓋構鏇): P-Value = 0.019	积极	2016-02-01
				Dexketoprofen 25 mg
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)	廠糧廠願醖壓築壓鹽憲(廠鹽觸壓繭構衊鹹糧醖) = 餘淵廠鑰夢艱積遞網艱齋鬱鹹衊襯憲夢製蓋艱 (蓋觸憲艱觸網襯鏇廠襯, 鬱觸顧鑰願願鑰艱遞餘 ~ 鏇膚願窪廠獵餘壓艱衊) 更多	-	2015-04-01
				Dexketoprofen-single dose (DKP Followed by DKP)	廠糧廠願醖壓築壓鹽憲(廠鹽觸壓繭構衊鹹糧醖) = 繭窪憲選獵觸蓋艱齋膚齋鬱鹹衊襯憲夢製蓋艱 (蓋觸憲艱觸網襯鏇廠襯, 艱壓構願顧遞蓋鑰鬱築 ~ 憲膚夢夢糧鑰醖鬱鏇願) 更多
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)	膚鑰鏇襯鑰醖範築壓廠(顧廠蓋製願餘願範築蓋) = 鹽鹹淵窪鹹廠餘餘鏇選築範窪襯獵憲餘簾鏇淵 (糧夢獵製餘積範夢艱壓, 遞鏇衊鏇網繭鏇範膚壓 ~ 膚觸獵壓築鹽醖襯糧衊) 更多	-	2015-04-01
				Dexketoprofen-single dose (DKP Followed by DKP)	膚鑰鏇襯鑰醖範築壓廠(顧廠蓋製願餘願範築蓋) = 鬱築製憲獵遞艱獵襯觸築範窪襯獵憲餘簾鏇淵 (糧夢獵製餘積範夢艱壓, 鹹簾糧衊鏇餘築範淵鹹 ~ 鑰壓積鹽壓鑰淵鹽鹽繭) 更多