Back to resultsA 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
Primary Purpose
Moderate to Severe Pain Due to Diabetic Polyneuropathy
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Oxycodone Naloxone
Placebo tablets
Sponsored by
About this trial
This is an interventional basic science trial for Moderate to Severe Pain Due to Diabetic Polyneuropathy
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
Sites / Locations
- Dr Oliver Emrich
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Tablets
Tablet
Arm Description
A placebo tablet to match the active reference treatment
Oxycodone Naloxone tablets
Outcomes
Primary Outcome Measures
Short Form McGill Pain Score.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00944697
First Posted
July 22, 2009
Last Updated
August 9, 2012
Sponsor
Mundipharma Research GmbH & Co KG
1. Study Identification
Unique Protocol Identification Number
NCT00944697
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research GmbH & Co KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Pain Due to Diabetic Polyneuropathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tablets
Arm Type
Placebo Comparator
Arm Description
A placebo tablet to match the active reference treatment
Arm Title
Tablet
Arm Type
Active Comparator
Arm Description
Oxycodone Naloxone tablets
Intervention Type
Drug
Intervention Name(s)
Oxycodone Naloxone
Intervention Description
Oxycodone Naloxone tablets
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
Placebo Oxycodone Naloxone tablets
Primary Outcome Measure Information:
Title
Short Form McGill Pain Score.
Description
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.
Time Frame
Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dr Oliver Emrich
City
Ludwigshafen
ZIP/Postal Code
67069
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.mundipharma-rd.eu
Description
Results available on website
Learn more about this trial
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
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