Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain
SuspendedPhase 4NCT00916890
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Chronic Administration of Opioids in Cancer Chronic Pain:an Open Prospective Study on Efficacy, Safety and Pharmacogenetic Factors Influence.
- Conditions
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Collaborators
- University of Pavia
- Start date
- 2009-02
- Primary completion
- 2015-02
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00916890