A Phase II, Proof of Concept Study of GRC 17536

• Research type

  Research Study

• Full title

  A Phase 2, 4-Week Randomised, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy.

• IRAS ID

  111343

• Contact name

  Peter Dewland

• Sponsor organisation

  Glenmark Pharmaceuticals SA

• Eudract number

  2012-002320-33

• 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. This study is designed to answer the following questions: 1. Whether GRC 17536 is an effective treatment for pain associated with diabetic peripheral neuropathy. 2. To assess safety and tolerability of GRC 17536 administered twice daily in patients with painful diabetic peripheral neuropathy (DPN).3. To assess how the drug is broken-down by the body. 4. To explore how the GRC 17536 works with rescue medication.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0332

• Date of REC Opinion

  27 Sep 2012

• REC opinion

  Further Information Favourable Opinion