Delving into the Latest Updates on Dexketoprofen Trometamol/Tramadol Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DKP.TRIS/TRAM, DKP.TRIS/TRAM.HCL, DKP/TRAM

+ [11]

Target

COX-1 x COX-2 x μ opioid receptor

Action

inhibitors, agonists

Mechanism

COX-1 inhibitors(Cyclooxygenase-1 inhibitors), COX-2 inhibitors(Cyclooxygenase-2 inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Acute Pain

Inactive Indication

Pain, Postoperative

Originator Organization

A. Menarini Industrie Farmaceutiche Riunite Srl

Active Organization

Menarini Ricerche SpA

A. Menarini Industrie Farmaceutiche Riunite Srl

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Spain (20 Dec 2015),

Acute Pain

Regulation-

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Structure/Sequence

Molecular FormulaC16H26ClNO2

InChIKeyPPKXEPBICJTCRU-NDFJEYLFSA-N

CAS Registry36282-47-0

View All Structures (2)

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).

Start Date10 Jan 2019

Sponsor / Collaborator-

NCT02777970

/ CompletedPhase 4

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.

Start Date01 Apr 2016

Sponsor / Collaborator

A. Menarini Industrie Farmaceutiche Riunite Srl

100 Clinical Results associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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100 Translational Medicine associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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100 Patents (Medical) associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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4

Literatures (Medical) associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

01 Aug 2024·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

Author: 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.

01 Mar 2024·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

Author: 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.

01 Jun 2018·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 Deals associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	M02AA27 M01AE17	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Pain	Spain	Menarini Ricerche SpA	20 Dec 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain, Postoperative	Preclinical	Latvia	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Germany	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Poland	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Serbia	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Ukraine	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Hungary	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Taiwan Province	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Czechia	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Spain	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013
Pain, Postoperative	Preclinical	Lithuania	A. Menarini Industrie Farmaceutiche Riunite Srl	01 Apr 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02777970 (DAVID, CTgov)	Phase 4	Acute Pain	654	Placebo+Tramadol Hydrochloride/Dexketoprofen Trometamol (Tramadol/Dexketoprofen)	jcqdsuuhnc(mgedbbvuuv) = nlijchazdc cinlmeompn (fmodfvupuo, rrujugreks - vmcvvzxkiq) View more	-	24 Mar 2021
				Placebo+Tramadol Hydrochloride/Paracetamol (Tramadol/Paracetamol)	jcqdsuuhnc(mgedbbvuuv) = xvodevqvem cinlmeompn (fmodfvupuo, bfgqwkahtg - bjmvexrzwn) View more
NCT01902134 \| EUCTR2012-004548-31-CZ (Pubmed \| Br J Anaesth)	Phase 3	Severe pain \| Moderate pain	641	Dexketoprofen/tramadol 25 mg/75 mg	uyihssvycy(zmqworhdnu): P-Value = 0.019	Positive	01 Feb 2016
				Dexketoprofen 25 mg
NCT01902134 (DAVID-art, CTgov)	Phase 3	Acute Pain \| Pain, Postoperative	641	Dexketoprofen/Tramadol-single dose (DKP/TRAM Followed by DKP/TRAM)	gscayvbzvu(kabaagavyi) = smjzoehdbz uekhfuxmkl (aufkklkvoj, ysqoeraxrf - swalnbdgdv) View more	-	01 Apr 2015
				Dexketoprofen-single dose (DKP Followed by DKP)	gscayvbzvu(kabaagavyi) = qgrwryepce uekhfuxmkl (aufkklkvoj, bikfnzevnj - tlbhzmqxzg) View more
NCT01904149 (DAVID lap, CTgov)	Phase 3	Acute Pain \| Pain, Postoperative	606	Dexketoprofen/Tramadol-single dose (DKP/TRAM Followed by DKP/TRAM)	osfbkrfeba(jiropdlfzu) = zggulxdhnm yjnkuhbtov (xjwnttuhba, wlcvacrbds - hmxftbjfrb) View more	-	01 Apr 2015
				Dexketoprofen-single dose (DKP Followed by DKP)	osfbkrfeba(jiropdlfzu) = bzlrvcsfwu yjnkuhbtov (xjwnttuhba, trnqwoqymx - fxkroofwfu) View more