Delving into the Latest Updates on Diclofenac/Tramadol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

COXs x μ opioid receptor

Action

inhibitors, agonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication-

Inactive Indication

Acute PainPain

Originator Organization

AbbVie, Inc.

Active Organization-

Inactive Organization

AbbVie, Inc.Grunenthal SA

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC16H26ClNO2

InChIKeyPPKXEPBICJTCRU-NDFJEYLFSA-N

CAS Registry36282-47-0

View All Structures (2)

Patients presented with acute pain from renal colic, the standard of care are prescribed NSAIDs, most common drug used is intramuscular (IM) Diclofenac injected at the gluteal muscle. Due to adverse effects in some patients, the nursing council has banned the injection by nurses. Since then, there has been a change in treatment by using intravascular (IV) Tramadol. According to various research, Diclofenac has a higher efficacy in controlling pain compared to other medications. In clinical practice, Tramadol has less efficacy of decreasing pain and a longer onset of action. At presence, there has been no research performed comparing the efficacy between these two drugs especially from the viewpoint of time dimension.

Start Date27 Apr 2022

Sponsor / Collaborator-

NCT03714672

/ CompletedPhase 3

A Randomized, Double-blind, Multi-site, Comparator-controlled, Phase III Trial to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Tramadol Hydrochloride and Diclofenac Sodium in Acute Moderate to Severe Pain After Third Molar Extraction

This study evaluated a new drug fixed-dose combination tablet (FDC) called tramadol/diclofenac at two different strengths (fixed doses of 25 milligrams [mg] of tramadol and of diclofenac or of 50 mg each). Tramadol and diclofenac each relieve pain, but they do so by different mechanisms. They were used alone as comparator drug in this study. Both are marketed drugs and are standard treatment for acute pain, including wisdom tooth removal.

Start Date26 Aug 2017

Sponsor / Collaborator

Grünenthal GmbH

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100 Clinical Results associated with Diclofenac/Tramadol

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100 Translational Medicine associated with Diclofenac/Tramadol

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100 Patents (Medical) associated with Diclofenac/Tramadol

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100 Deals associated with Diclofenac/Tramadol

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Pain	Phase 3	Mexico	Grunenthal SA	26 Aug 2017
Pain	Phase 3	-	AbbVie, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03714672 (CTgov)	Phase 3	Acute Pain	1,151	Tramadol/Diclofenac 50/50 (Tramadol/Diclofenac 50/50)	uawgrsjdch(fhpjuglxhk) = iqickqziit plzqgihway (gqltpkhflb, vmnadbzmez - vmbvwgqbio) View more	-	24 Jul 2019
				Tramadol/Diclofenac 25/25 (Tramadol/Diclofenac 25/25)	uawgrsjdch(fhpjuglxhk) = eokiqikymz plzqgihway (gqltpkhflb, pgxqgyrxnr - ujghaywxxa) View more
WCO_IOF_ESCEO2015	Phase 3	Musculoskeletal Pain	52	Tramadol-Diclofenac	tlbmgnfnbb(mjiveannrg) = nausea, vomiting, epigastric pain, gastritis gklavnddcg (idsoljlzue )	Positive	17 Apr 2015
				Tramadol-Paracetamol