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.

First Received on July 22, 2009. Last Updated on April 23, 2010 History of Changes

Sponsor:	Mundipharma Research GmbH & Co KG
Information provided by:	Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:	NCT00944697

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

Drug Information available for: Oxycodone Pregabalin Oxycodone hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

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

Primary Outcome Measures:

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

Estimated Enrollment:	80
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

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00944697 History of Changes
Other Study ID Numbers:	OXN2502, 2008-005815-17
Study First Received:	July 22, 2009
Last Updated:	April 23, 2010
Health Authority:	Germany: Ethikkommission der Landesärztekammer; Czech Republic: MEC FN and LF Olomouc; Hungary: Central Ethic Committee for Clinical Pharmacology; Romania: National Ethics Committee for Drug Clinical Study

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 February 09, 2012