Status:
COMPLETED
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
Lead Sponsor:
Mundipharma Research GmbH & Co KG
Conditions:
Moderate to Severe Pain Due to Diabetic Polyneuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00944697
Start Date
July 1 2009
End Date
April 1 2010
Last Update
August 17 2012
Active Locations (1)
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1
Dr Oliver Emrich
Ludwigshafen, Germany, 67069