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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mundipharma Research GmbH & Co KG

ClinicalTrials.gov Identifier:

NCT00944697

First received: July 22, 2009

Last updated: August 9, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 22, 2009
Last Updated Date	August 9, 2012
Start Date ^ICMJE	July 2009
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2012)	Short Form McGill Pain Score. [ Time Frame: Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal) ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: July 22, 2009)	To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone
Change History	Complete list of historical versions of study NCT00944697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Moderate to Severe Pain Due to Diabetic Polyneuropathy
Intervention ^ICMJE	Drug: Oxycodone Naloxone Oxycodone Naloxone tablets Drug: Placebo tablets Placebo Oxycodone Naloxone tablets
Study Arm (s)	Placebo Comparator: Tablets A placebo tablet to match the active reference treatment Intervention: Drug: Placebo tablets Active Comparator: Tablet Oxycodone Naloxone tablets Intervention: Drug: Oxycodone Naloxone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	98
Completion Date	April 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00944697
Other Study ID Numbers ^ICMJE	OXN2502, 2008-005815-17
Has Data Monitoring Committee	No
Responsible Party	Mundipharma Research GmbH & Co KG
Study Sponsor ^ICMJE	Mundipharma Research GmbH & Co KG
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mundipharma Research GmbH & Co KG
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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