At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 98 enrolled
Drug / intervention
Oxycodone Naloxone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Oxycodone Naloxone and Placebo tablets for Moderate to Severe Pain Due to Diabetic Polyneuropathy. Completed, enrolled 98 participants across 1 site.
Detailed Summary
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionMar 2010
Study CompletionApr 2010
TodayJul 2026
First PostedJul 23, 2009
Enrollment StartJul 1, 2009
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.9 years ago
Interventions
Oxycodone Naloxonedrug
Oxycodone Naloxone tablets
Placebo tabletsdrug
Placebo Oxycodone Naloxone tablets