Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.

The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.

Inclusion Criteria:

• Men and women, 18 to 75 years old.
• Type 1 or type 2 diabetes.
• Painful DPN symptoms and signs for at least 3 months.
• Blood glucose controlled with medication.
• Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
• Prior analgesic medication.
• Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.

Exclusion Criteria:

• Impaired liver, cardiac or renal function.
• Breastfeeding and pregnancy.
• History of substance abuse, alcohol or medication.
• Chronic gastrointestinal disease.
• History of seizures and or epilepsy.
• History or presence of malignancy.
• Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
• Allergies to opioids, acetaminophen or excipients of the medications.