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:
Mundipharma Research GmbH & Co KG
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
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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 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 |
ClinicalTrials.gov processed this record on May 21, 2013