Delving into the Latest Updates on Caffeine/Ibuprofen with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

Mechanism

A1R antagonists(Adenosine A1 receptor antagonists), A2aR antagonists(Adenosine A2a receptor antagonists), COX inhibitors(Cyclooxygenases inhibitors)

Therapeutic Areas

Nervous System Diseases

Active Indication

Pain

Inactive Indication

Back PainNeck PainPain, Postoperative+ [1]

Originator Organization

C.H. Boehringer Sohn AG & Co. KG

Active Organization

C.H. Boehringer Sohn AG & Co. KG

Inactive Organization

Boehringer Ingelheim GmbH

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure

Molecular FormulaC13H18O2

InChIKeyHEFNNWSXXWATRW-UHFFFAOYSA-N

CAS Registry15687-27-1

View All Structures (2)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF A NOVEL FIXED-DOSE COMBINATION OF IBUPROFEN 400 MG WITH CAFFEINE 100 MG TO IBUPROFEN 400 MG AND TO PLACEBO IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN IN OTHERWISE HEALTHY SUBJECTS

An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.

Start Date24 Oct 2017

Sponsor / Collaborator

Pfizer Inc.

NCT01929031 / CompletedPhase 3

A Single-centre, Double-blind, Randomised, Two-stage, Parallel-group Study to Assess the Efficacy and Safety of the Fixed Dose Combination of Ibuprofen 400 mg and Caffeine 100 mg Versus Ibuprofen 400 mg, Caffeine 100 mg and Placebo in Patients With Postoperative Dental Pain

The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage 1). A secondary objective is to evaluate efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day post-surgical period (study stage 2).

Start Date01 Aug 2013

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT01879371 / CompletedPhase 1

Relative Bioavailability of Ibuprofen From a Fixed Dose Combination (FDC) Tablet of Ibuprofen 400 mg and Caffeine 100 mg Compared to a Tablet of Ibuprofen 400 mg and a Tablet of Ibuprofen Lysinate 400 mg Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period Crossover Study)

To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate (Nurofen Immedia®).

Start Date01 Jun 2013

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Caffeine/Ibuprofen

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100 Translational Medicine associated with Caffeine/Ibuprofen

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100 Patents (Medical) associated with Caffeine/Ibuprofen

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100 Deals associated with Caffeine/Ibuprofen

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Back Pain	Phase 3	DE	Boehringer Ingelheim GmbH	20 Dec 2016
Back Pain	Phase 3	RU	Boehringer Ingelheim GmbH	20 Dec 2016
Neck Pain	Phase 3	DE	Boehringer Ingelheim GmbH	20 Dec 2016
Neck Pain	Phase 3	RU	Boehringer Ingelheim GmbH	20 Dec 2016
Pain, Postoperative	Phase 3	US	Boehringer Ingelheim GmbH	01 Aug 2013
Toothache	Phase 3	US	Boehringer Ingelheim GmbH	01 Aug 2013
Pain	Phase 3	-	C.H. Boehringer Sohn AG & Co. KG	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02863575 (CTgov)	Phase 3	Toothache \| Pain, Postoperative	374	Placebo	eygmppxtml(hwgizasddr) = dgvaycabds iqducghpez (wubcomjgwu, naevlblnhp - lfydfueify) View more	-	08 Apr 2019
NCT01879371 (CTgov)	Phase 1	-	36	Ibuprofen+Caffeine (Ibuprofen + Caffeine (FDC) Tablet)	colafykcgy(qmkspzaxts) = zwekxeehoj lhbmxlyrvm (fmrxkqjeab, rwkkwyltms - uwxdwcnuue) View more	-	16 Nov 2016
				Ibuprofen Acid (Ibuprofen Acid Film-coated Tablet)	colafykcgy(qmkspzaxts) = edulvqimqw lhbmxlyrvm (fmrxkqjeab, kynvewtacj - zfhanmoauu) View more
NCT01929031 (CTgov)	Phase 3	Toothache \| Pain, Postoperative	562	Placebo (Placebo)	womldqcqng(lftgxunzcz) = hkmycqqyqv ztuzpybgyf (xavhbsnkpk, wylurbdkox - yewkoeeclj) View more	-	16 Nov 2016
				Caffeine (Caffeine)	womldqcqng(lftgxunzcz) = gtrckjjmhn ztuzpybgyf (xavhbsnkpk, qalxyqisde - wxwqsunvza) View more