alexa
Reach Us +44-1477412632
Developing New Molecules for the Treatment of Painful Diabetic Peripheral Neuropathy: Is it Feasible given the Magnitude of the Placebo Response in Proof of Concept Clinical Studies | Abstract
ISSN: 2155-6156

Journal of Diabetes & Metabolism
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Review Article

Developing New Molecules for the Treatment of Painful Diabetic Peripheral Neuropathy: Is it Feasible given the Magnitude of the Placebo Response in Proof of Concept Clinical Studies

Domenico Merante1*, George Skouteris1 and Rayaz Malik2

1Daiichi Sankyo Development Ltd., UK

2Centre of Endocrinology and Diabetes - Institute of Human Development, University of Manchester, UK

*Corresponding Author:
Domenico Merante
Senior Director Clinical Development
Daiichi Sankyo Development Ltd. Chiltern Place
Chalfont Park, Gerrards Cross
Buckinghamshire-SL9 0BG, UK
Tel: 0044 (0) 1753482802
Fax: 0044 (0) 1753899107
E-mail: [email protected]

Received date: September 20, 2013; Accepted date: October 29, 2013; Published date: November 05, 2013

Citation: Merante D, Skouteris G, Malik R (2013) Developing New Molecules for the Treatment of Painful Diabetic Peripheral Neuropathy: Is it Feasible given the Magnitude of the Placebo Response in Proof of Concept Clinical Studies? J Diabetes Metab 4:305. doi:10.4172/2155-6156.1000305

Copyright: © 2013 Merante D, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Randomised, double blind, placebo controlled studies are necessary in neuropathic pain clinical research arena. Few drugs are approved for the indication of painful Diabetic Peripheral Neuropathy (DPN): typically these drugs lose their therapeutic response over time and have far from an ideal tolerability risk profile. In addition to that, the response to placebo continues to represent a significant challenge in clinical trials of painful DPN, as well as any other neuropathic pain condition. Hence to date few molecules have progressed to phase 3 in painful DPN and even fewer have gained approval. Thus several studies failed because the primary endpoint of statistical superiority to placebo and a clinically relevant reduction of ADPS (Average Daily Pain Score) were not achieved. Any attempt to mitigate the placebo response in this condition may allow future new drugs to successfully progress from Proof of Concept to phase 3 of clinical development and hopefully to their approval. As of today this remains a relevant challenge in a therapeutic area of a well-recognized unmet medical need. The dangers of treating acute and chronic pain with opioids, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or acetaminophen are considerable. By mitigating the placebo response in neuropathic pain clinical trials, this may expedite the discovery, selection and development of improved analgesic treatments for the benefit of public health. In addition, a better understanding of subjects’ typology would be of great help to identify those who really need a more specific pharmacological treatment approach from those subjects who don`t and might benefit instead from alternative non-pharmacological approaches.

Keywords

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

https://www.gaziantepescort.info

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version