Clinical trial · Interventional
Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain
Chronic Administration of Opioids in Cancer Chronic Pain:an Open Prospective Study on Efficacy, Safety and Pharmacogenetic Factors Influence.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulties in patients enrolment
Summary
Brief summary (as posted)
Aim of this project is to customize the choice of the strong opioid in the treatment of cancer chronic pain through the identification of patient clinical history and pain characteristics, moreover in the analysis the investigators will also correlate the clinical efficacy and safety of opioid treatment with pharmacokinetic and pharmacogenetic patterns in order to identify variables able to predict the efficacy of the treatment or the patient susceptibility towards a specific treatment. Furthermore with this study the investigators want to identify the pharmacogenomic characterization responsible for pharmacokinetic variability in the conversion between morphine and other opioids, in order to validate the currently available conversion tables from a pharmacokinetic viewpoint, estimating the influence of the most common genetic polymorphisms, and if this characterization could be useful and cost-effective. This study will also focus on the specific clinical-pharmacological response in the elderly and between male and female and on the interactions between opioids and those anticonvulsant and antidepressant drugs routinely used in the pain therapy (study of pharmacovigilance).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Buprenorphine | Drug | — | UNRESOLVED |
| Fentanyl | Drug | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
| Oxycodone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Oral extended-release morphine
- interventionNames
- Drug: Morphine
- type
- ACTIVE_COMPARATOR
- label
- Oral extended-release oxycodone
- interventionNames
- Drug: Oxycodone
- type
- ACTIVE_COMPARATOR
- label
- Transdermal fentanyl
- interventionNames
- Drug: Fentanyl
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult oncologic patients (\>= 18 years old) * Chronic peripheral neuropathic and/or nociceptive pain * Written informed consent Exclusion Criteria: * Pediatric patients * Mental impaired patients * Substance abuse disorder * Opioid allergy * History of opioids use or addiction * Severe immunodeficiency, severe renal impairment, severe liver disease * Cachectic state * HIV positive patients
References
Publications (1)
- DERIVEDDe Gregori S, Minella CE, De Gregori M, Tinelli C, Ranzani GN, Govoni S, Allegri M, Regazzi M. Clinical pharmacokinetics of morphine and its metabolites during morphine dose titration for chronic cancer pain. Ther Drug Monit. 2014 Jun;36(3):335-44. doi: 10.1097/FTD.0000000000000009. PMID 24595069