Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

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

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944697


Locations
Layout table for location information
Germany
Dr Oliver Emrich
Ludwigshafen, Germany, 67069
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00944697    
Other Study ID Numbers: OXN2502
2008-005815-17
First Posted: July 23, 2009    Key Record Dates
Results First Posted: February 28, 2012
Last Update Posted: August 17, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyneuropathies
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Oxycodone
 Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists