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
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
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-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy
Study design: Basic Science, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
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; Recruiting
Margaret Wilson, Email: info@contact-clinical-trials.com
Jill Kiteley, Email: info@contact-clinical-trials.com
Additional Information
Starting date: July 2009
Ending date: May 2010
Last updated: August 11, 2009
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