GREAT - Good Response With Appropriate Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02293785|
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : March 21, 2016
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.
|Condition or disease||Intervention/treatment|
|Cancer Pain Neoplasms||Drug: Oxycodone-Naloxone|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|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 Start Date :||November 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
- non responders [ Time Frame: 28 days ]Subjects will be classified as non-responders (NR) to treatment if between from the first and to last visit during the follow-up will not exhibit a reduction in average pain at least 30% and/or do not reach a final score of ≤ 4 pain points, defined as average pain experienced in the last 24 hours and measured by an 11-point numerical scale from 0 (no pain) to 10 (maximum pain imaginable).
- Opioids Escalation Index [ Time Frame: 28 days ]Percentage of subjects that will need during the follow-up an increase in daily opioid dose ≥5%, measured by the OEI% (Opioids Escalation Index). The value of 5% identifies the cut-off between the increases of dose considered normal or high entity.
- additional opioid treatment [ Time Frame: 28 days ]Proportion of subjects that will need during the follow-up of an action to "additional" opioid treatment, in addition to the basic treatment programmed, to maintain the analgesic response in the treatment "around the clock".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293785
|IRCCS Centro di Riferimento Oncologico di Aviano|
|Ospedale degli Infermi di Biella|
|Biella, Italy, 13900|
|Ospedale Oncologico A. Businco|
|E.O. Ospedali Galliera Genova|
|Presidio Ospedaliero di Macerata|
|IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano|
|Istituto Scientifico San Raffaele|
|Ospedale di Mirano|
|Ospedale V. Monaldi|
|IRCCS Istituto Oncologico Veneto|
|Ospedale di Piacenza|
|Fondazione PTV Policlinico Tor Vergata|
|Ospedale San Camillo Forlanini|
|Policlinico Umberto I Università Sapienza|
|Policlinico Umberto I|
|A.O. Valtellina e Valchiavenna|
|Ospedale SS Trinità - Sora|
|Hospice "Raggio di Sole" SPA TP2|