A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).

Summary

Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.

Conditions

• Painful Diabetic Peripheral Neuropathy

Interventions

DRUG

GRC 17356

DRUG

Matching Placebo

Sponsors & Collaborators

• Glenmark Pharmaceuticals S.A.

  collaborator INDUSTRY

• Glenmark Pharmaceuticals Ltd. India

  lead INDUSTRY

Principal Investigators

• Dr. Balamurugan Ramanathan · Kovai Diabetes Speciality Centre and Hospital

• Dr. Vijay Viswanathan · MV Hospital for Diabetes (P) Ltd

• Dr. Mallikarjun V Jali · K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre

• Dr. Sunil M Jain · TOTALL Diabetes Hormone Institute

• Dr. Dinesh Dhanwal · Maulana Azad Medical College & Associate Hospitals

• Dr. S Srikanta · Jnana Sanjeevani Medical Centre

• Dr. Jayashri Shembalkar · Getwell Hospital and Research Centre

• Dr Peter Dewland · ICON Manchester CPU

• Dr. Prof Thomas Forst · Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)

• Dr. Paramesh Shammana · Bangalore Clinisearch

• Dr. Arthur Asirvatham · Arthur Asirvathma Hospital

• Dr. Mohan Magdum · Jehangir Clinical Development Centre Pvt. Ltd.

• Dr. Blanka Lubenova · NeuroHelp s.r.o

• Dr. David Dolezil · DADO Medical s.r.o

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2014-08-31

Completion

2014-09-30

Countries

• Czechia
• Germany
• India
• United Kingdom

Study Locations