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 Diabetic Polyneuropathy

Mundipharma Research GmbH & Co KG98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Moderate to Severe Pain Due to Diabetic Polyneuropathy

Interventions

Oxycodone NaloxoneDRUG

Oxycodone Naloxone tablets

Placebo tabletsDRUG

Placebo Oxycodone Naloxone tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr Oliver Emrich

Ludwigshafen, Germany

Outcomes

Primary Outcomes

Short Form McGill Pain Score.

The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B - rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain.

Time frame: Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)

Data from ClinicalTrials.gov

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