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Brief Title: GREAT - Good Response With Appropriate Treatment
Official Title: GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"
Study ID: NCT02293785
Brief Summary: The symptoms associated in advanced cancer patients and adverse events due to use of opioids have major influence on the state of health and quality of life of patients. The pain, in particular, is a symptom with severe negative impact and with a prevalence ranging between 33% and 64%, according to the stage of the disease, with values around 70-90% in advanced stages and metastatic. The use of opioids, however, is usually associated with the appearance of common adverse events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting in the time for the appearance of tolerance while others, as constipation persist. Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN), which consists in the union between a molecule agonist and an antagonist of opioid receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared to oxycodone alone.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRCCS Centro di Riferimento Oncologico di Aviano, Aviano, , Italy
Ospedale degli Infermi di Biella, Biella, , Italy
Ospedale Oncologico A. Businco, Cagliari, , Italy
E.O. Ospedali Galliera Genova, Genova, , Italy
Presidio Ospedaliero di Macerata, Macerata, , Italy
IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano, Milano, , Italy
Istituto Scientifico San Raffaele, Milano, , Italy
Ospedale di Mirano, Mirano, , Italy
Ospedale V. Monaldi, Napoli, , Italy
IRCCS Istituto Oncologico Veneto, Padova, , Italy
Ospedale di Piacenza, Piacenza, , Italy
Fondazione PTV Policlinico Tor Vergata, Roma, , Italy
Ospedale San Camillo Forlanini, Roma, , Italy
Policlinico Umberto I Università Sapienza, Roma, , Italy
Policlinico Umberto I, Roma, , Italy
A.O. Valtellina e Valchiavenna, Sondalo, , Italy
Ospedale SS Trinità - Sora, Sora, , Italy
Hospice "Raggio di Sole" SPA TP2, Trapani, , Italy