Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy

The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.

Inclusion Criteria:

• Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.

Exclusion Criteria:

• Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
• non Caucasian or Hispanic.
• Concomitant painful disease.
• Life-long history of seizure disorder or epilepsy.
• Subjects with clinical relevant cardiac and vascular diseases.
• Subjects with impaired renal function
• Subjects with impaired hepatic function
• Female subjects who are pregnant or breastfeeding.