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

July 22, 2009
August 9, 2012
July 2009
March 2010   (final data collection date for primary outcome measure)
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.
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone
Complete list of historical versions of study NCT00944697 on ClinicalTrials.gov Archive Site
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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
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Moderate to Severe Pain Due to Diabetic Polyneuropathy
  • Drug: Oxycodone Naloxone
    Oxycodone Naloxone tablets
  • Drug: Placebo tablets
    Placebo Oxycodone Naloxone tablets
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
April 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00944697
OXN2502, 2008-005815-17
No
Mundipharma Research GmbH & Co KG
Mundipharma Research GmbH & Co KG
Not Provided
Not Provided
Mundipharma Research GmbH & Co KG
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP