Conditions: Moderate to Severe Pain Due to Diabetic Polyneuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 98
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: A placebo tablet to match the active reference treatment arm 2: Oxycodone Naloxone tablets

Interventions: intervention 1: Oxycodone Naloxone intervention 2: Placebo tablets
Intervention descriptions: intervention 1: Oxycodone Naloxone tablets intervention 2: Placebo Oxycodone Naloxone tablets

Protocol document: