Phase II Proof of Concept Study of GRC17536 in patients with PDN

• Research type

  Research Study

• Full title

  A Phase II, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Neuropathy

• IRAS ID

  98912

• Contact name

  Peter Dewland

• Sponsor organisation

  Glenmark Pharmaceuticals SA

• Eudract number

  2011-005879-16

• ISRCTN Number

  No number

• Clinicaltrials.gov Identifier

  No number

• Research summary

  GRC 17536 is a new drug which is being developed by Glenmark Pharmaceuticals SA (a pharmaceutical company with its headquarters based in India) with the aim of helping people with painful diabetic neuropathy. Diabetic neuropathy is a condition, which affects the nerves in diabetic patients. The purpose of this study is to help answer the following research question(s):?½ To see if GRC 17536 can help patients with painful diabetic neuropathy who have had a poor response to other treatments available for this condition ?½ To find out how much GRC 17536 should be given to patients with painful diabetic neuropathy to relieve their pain ?½ To study the safety and tolerability of GRC 17536 and any side effects that might occur ?½ To investigate how the body takes up, breaks down, and gets rid of GRC 17536.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  12/EE/0050

• Date of REC Opinion

  23 Mar 2012

• REC opinion

  Further Information Favourable Opinion