Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH; Tris Pharma, Inc.
• Treatments: Analgesics

Criteria

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.