A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diab

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

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

Details

• Lead Sponsor: Mundipharma Research GmbH & Co KG
• Treatments: Analgesics; Naloxone; Oxycodone; Pregabalin

Criteria

Inclusion criteria:

• Moderate to severe pain due diabetic polyneuropathy

• Opioid-naive subjects

Exclusion criteria:

• Females who are pregnant or lactating

• Subjects with evidence of significant structural abnormalities of the gastrointestinal tract

• Subjects with evidence of impaired liver/kidney function upon entry into the study