Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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.