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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944697
• Other study ID #: OXN2502
• Secondary ID: 2008-005815-17
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2009
• Last updated: August 9, 2012
• Start date: July 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2012
• Source: Mundipharma Research GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArMCzech Republic: Ethics CommitteeHungary: Institutional Ethics CommitteeRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Moderate to Severe Pain Due to Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Drug:
• Oxycodone Naloxone
Oxycodone Naloxone tablets
• Placebo tablets
Placebo Oxycodone Naloxone tablets

Locations

Country	Name	City	State
Germany	Dr Oliver Emrich	Ludwigshafen

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)	No

External Links

•   Results available on website