At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 target
Drug / intervention
oxycodone +1 moredrug
Likely dose
oxycodone 20 mgfrom 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.
Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain
In Brief
A Phase 2 clinical trial evaluating oxycodone and pregabalin for Cancer and Pain. Completed, enrolled 80 participants across 8 sites.
Detailed Summary
The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsMario Negri Institute for Pharmacological Research
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedMar 2008
Primary CompletionDec 2010
TodayJul 2026
First PostedMar 18, 2008
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.3 years ago
Interventions
oxycodonedrug
Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops.
pregabalindrug
Arm A - pregabalin at increasing dose starting from 50 mg/day Arm B - pregabalin 50 mg/day For 15 days or until unacceptable toxicity develops.