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

NCT01556152 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-11-12

No results posted yet for this study

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 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of painful DPN. Generally, 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.

This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to DPN for least 6 months and no greater than 5 years.

Patients will be recruited after providing written informed consent.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

GRC 17536 (Medium Dose)

1 BD for 28 days

DRUG

GRC 17536 (Low Dose)

1 BD for 28 Days

DRUG

Placebo

Matching Placebo for 28 Days

Sponsors & Collaborators

  • Glenmark Pharmaceuticals S.A.

    collaborator INDUSTRY

  • Glenmark Pharmaceuticals Ltd. India

    lead INDUSTRY

Principal Investigators

  • Dr. Kavita Muchandi, MD · Glenmark Pharmaceuticals Ltd

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

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01556152 on ClinicalTrials.gov