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Spots Global Cancer Trial Database for GREAT - Good Response With Appropriate Treatment

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Trial Identification

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

Interventions

Oxycodone-Naloxone

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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