Clinical trial · Interventional
Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
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
NCT00637975CI-TRIAL-00004385completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxycodone | Drug | — | UNRESOLVED |
| pregabalin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
- interventionNames
- Drug: oxycodone
- Drug: pregabalin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
- interventionNames
- Drug: oxycodone
- Drug: pregabalin
Primary outcomes (1)
- measure
- Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (29)
- BACKGROUNDMerskey H, Bugduk N. Classification of chronic pain. Description of chronic pain. Description of chronic pain syndromes and definitions of chronic pain terms. Seattle: IASP, press 1994
- BACKGROUNDNegri E, Bettaglio R, Demartini L, Allegri M, Barbieri M, Miotti D, Paulin L, Buonocore M, Bonezzi C. [Validation of the Italian version of the "Neuropathic Pain Scale" and its clinical applications]. Minerva Anestesiol. 2002 Mar;68(3):95-104. Italian. PMID 11981518
- BACKGROUNDRiley J, Ross JR, Rutter D, Wells AU, Goller K, du Bois R, Welsh K. No pain relief from morphine? Individual variation in sensitivity to morphine and the need to switch to an alternative opioid in cancer patients. Support Care Cancer. 2006 Jan;14(1):56-64. doi: 10.1007/s00520-005-0843-2. Epub 2005 Jun 11. PMID 15952009
- BACKGROUNDMucci-LoRusso P, Berman BS, Silberstein PT, Citron ML, Bressler L, Weinstein SM, Kaiko RF, Buckley BJ, Reder RF. Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study. Eur J Pain. 1998;2(3):239-49. doi: 10.1016/s1090-3801(98)90020-9. PMID 15102384
- BACKGROUNDBruera E, Belzile M, Pituskin E, Fainsinger R, Darke A, Harsanyi Z, Babul N, Ford I. Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain. J Clin Oncol. 1998 Oct;16(10):3222-9. doi: 10.1200/JCO.1998.16.10.3222. PMID 9779695
- BACKGROUNDAltier N, Dion D, Boulanger A, Choiniere M. Management of chronic neuropathic pain with methadone: a review of 13 cases. Clin J Pain. 2005 Jul-Aug;21(4):364-9. doi: 10.1097/01.ajp.0000125247.95213.53. PMID 15951657
- BACKGROUNDGralow I. Cancer pain: an update of pharmacological approaches in pain therapy. Curr Opin Anaesthesiol. 2002 Oct;15(5):555-61. doi: 10.1097/00001503-200210000-00014.