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

Phase 2

Completed

• Conditions: Moderate to Severe Pain Due to Diabetic Polyneuropathy
• Interventions: Drug: Placebo tablets; Drug: Oxycodone Naloxone

• Registration Number: NCT00944697
• Lead Sponsor: Mundipharma Research GmbH & Co KG

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Results First Submitted: 2011-11-22
• Results First Submitted QC: 2012-01-26
• Results First Posted: 2012-02-28
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-09
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tablets	Placebo tablets	A placebo tablet to match the active reference treatment
Tablet	Oxycodone Naloxone	Oxycodone Naloxone tablets

Primary Outcome Measures

Name	Time	Method
Short Form McGill Pain Score.	Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)	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.

Trial Locations

Locations (1)

Dr Oliver Emrich; 🇩🇪 Ludwigshafen, Germany