Moderate to Severe Pain Due to Diabetic Polyneuropathy Clinical Trial
Official title:
An Exploratory, Randomised, Double-blind, Single-dummy, Placebo Controlled, Parallel Group 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 Diabetic Polyneuropathy
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science