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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 7
- Primary Endpoint
- Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
Study Overview
Brief 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.
Detailed Description
Neuropathic pain is frequently diagnosed as a complication of cancer pain. While opioids are the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often combined with opioids in the analgesic regimen of patients with neuropathic cancer pain. This approach is suggested by well-established guidelines, but the analgesic benefit and the safety of pregabalin and oxycodone in combination is not yet documented.
The aim of this study is to assess the activity and tolerability of the addition of pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •instrumental and clinical diagnosis of every malignant neoplasm
- •presence of pain with a neuropathic component in the opinion of the physician
- •presence of pain >=4(NRS)
- •PS ECOG <3
- •written informed consent
Exclusion Criteria
- •serum creatinine >2mg/ml or creatinine clearance <40 ml/min
- •mild or severe hepatic insufficiency
- •iatrogenic neuropathy caused by chemotherapeutic agents
- •previous allergic reactions to oxycodone and pregabalin
- •pregnancy or breastfeeding
Arms & Interventions
A
oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
Intervention: oxycodone (Drug)
A
oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
Intervention: pregabalin (Drug)
B
pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
Intervention: oxycodone (Drug)
B
pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
Intervention: pregabalin (Drug)
Outcomes
Primary Outcomes
Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
Time Frame: within 15 days
Secondary Outcomes
- Pain control rate(within 15 days)
- Reduction of Break Through Pain number(within 15 days)
- Record of adverse events(within 15 days)
- Reduction of allodynia in patients presenting it at T0(within 15 days)
- Patient satisfaction(within 15 days)
- Assessing whether COMT and mu blood polymorphisms are associated to response(within 15 days)