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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

Information source: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Moderate to Severe Pain Due to Diabetic Polyneuropathy

Intervention: Oxycodone Naloxone (Drug); Placebo tablets (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Mundipharma Research GmbH & Co KG

Summary

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

Clinical Details

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-nave Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Short Form McGill Pain Score.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dr Oliver Emrich, Ludwigshafen 67069, Germany
Additional Information

Results available on website

Starting date: July 2009
Last updated: August 9, 2012

Page last updated: August 23, 2015

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