Safety and efficacy of GRT6005 in pain due to diabetic polyneuropathy

• Research type

  Research Study

• Full title

  KF6005/02. A randomised Phase IIa trial evaluating the safety and efficacy of a new centrally acting analgesic in subjects with pain due to diabetic polyneuropathy.

• IRAS ID

  14737

• Sponsor organisation

  Grünenthal GmbH

• Eudract number

  2008-004794-18

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a randomized, crossover, multiple drug administration trial in 108 patients aged between 18 and 75 who suffer from painful diabetic peripheral neuropathy (DPN) due to type I or type II diabetes mellitus. Subjects must be unhappy with their current treatment regime to control the DPN pain. The trial consists of 4 sequential crossover parts (Parts A, B, C and D). Each subject may only participate in one part of the study. Each part has a crossover design incorporating 3 treatment periods of 5 days followed by a washout period of 5-9 days in treatment periods 1 and 2 and 5 days in treatment period 3. During the treatment periods the subject will receive one of two doses of GRT6005 or placebo once a day for 5 days in a pre-designed sequence. Part A will be conducted using doses of 40æg and 120æg of GRT6005 and placebo. In part D subjects will receive one dose of GRT6005, morphine Sulphate 60mg CR and placebo. Following each period a Data Review Board will review the data, looking particularly at safety and efficacy of GRT6005, and decide upon the doses to be used in the next study part. If the optimum dose has been ascertained in parts A and B of the study Part C will not be carried out. GRT6005 has been given safely in doses up to 800æg per day in two previous studies, however the maximum dose in this study will be 400æg.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/4

• Date of REC Opinion

  22 Jan 2009

• REC opinion

  Further Information Favourable Opinion