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
  Purpose

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


Condition Intervention Phase
Moderate to Severe Pain Due to Diabetic Polyneuropathy
Drug: Oxycodone Naloxone
Drug: Placebo tablets
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Mundipharma Research GmbH & Co KG:

Primary Outcome Measures:
  • 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.


Enrollment: 98
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Tablets
A placebo tablet to match the active reference treatment
Drug: Placebo tablets
Placebo Oxycodone Naloxone tablets
Active Comparator: Tablet
Oxycodone Naloxone tablets
Drug: Oxycodone Naloxone
Oxycodone Naloxone tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944697

Locations
Germany
Dr Oliver Emrich
Ludwigshafen, Germany, 67069
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
  More Information

Additional Information:
No publications provided

Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00944697     History of Changes
Other Study ID Numbers: OXN2502, 2008-005815-17
Study First Received: July 22, 2009
Results First Received: November 22, 2011
Last Updated: August 9, 2012
Health Authority: Germany: BfArM
Czech Republic: Ethics Committee
Hungary: Institutional Ethics Committee
Romania: National Medicines Agency

Additional relevant MeSH terms:
Polyneuropathies
Diabetic Neuropathies
Stress, Psychological
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Behavioral Symptoms
Analgesics
Oxycodone
Pregabalin
Naloxone
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists
Narcotics
Central Nervous System Depressants
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014