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

• ClinicalTrials.gov Identifier: NCT00944697
• Recruitment Status: Completed
• First Posted: July 23, 2009
• Results First Posted: February 28, 2012
• Last Update Posted: August 17, 2012
• Sponsor: Mundipharma Research GmbH & Co KG
• Information provided by (Responsible Party): Mundipharma Research GmbH & Co KG

Tracking Information

• First Submitted Date: July 22, 2009
• First Posted Date: July 23, 2009
• Results First Submitted Date: November 22, 2011
• Results First Posted Date: February 28, 2012
• Last Update Posted Date: August 17, 2012
• Study Start Date: July 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2012)

Short Form McGill Pain Score. [ Time Frame: 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.

• Original Primary Outcome Measures (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
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Moderate to Severe Pain Due to Diabetic Polyneuropathy

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2012): 98
• Original Estimated Enrollment (submitted: July 22, 2009): 80
• Actual Study Completion Date: April 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00944697
• Other Study ID Numbers: OXN2502; 2008-005815-17
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mundipharma Research GmbH & Co KG
• Original Responsible Party: Not Provided
• Current Study Sponsor: Mundipharma Research GmbH & Co KG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mundipharma Research GmbH & Co KG
• Verification Date: August 2012