GREAT - Good Response With Appropriate Treatment

March 18, 2016 updated by: Mario Negri Institute for Pharmacological Research

GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Aviano, Italy
        • IRCCS Centro di Riferimento Oncologico di Aviano
      • Biella, Italy, 13900
        • Ospedale degli Infermi di Biella
      • Cagliari, Italy
        • Ospedale Oncologico A. Businco
      • Genova, Italy
        • E.O. Ospedali Galliera Genova
      • Macerata, Italy
        • Presidio Ospedaliero di Macerata
      • Milano, Italy
        • Istituto Scientifico San Raffaele
      • Milano, Italy
        • IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano
      • Mirano, Italy
        • Ospedale di Mirano
      • Napoli, Italy
        • Ospedale V. Monaldi
      • Padova, Italy
        • IRCCS Istituto Oncologico Veneto
      • Piacenza, Italy
        • Ospedale di Piacenza
      • Roma, Italy
        • Policlinico Umberto I
      • Roma, Italy
        • Fondazione PTV Policlinico Tor Vergata
      • Roma, Italy
        • Ospedale San Camillo Forlanini
      • Roma, Italy
        • Policlinico Umberto I Università Sapienza
      • Sondalo, Italy
        • A.O. Valtellina e Valchiavenna
      • Sora, Italy
        • Ospedale SS Trinità - Sora
      • Trapani, Italy
        • Hospice "Raggio di Sole" SPA TP2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study involves a pain longitudinal evaluation in cancer patients through a follow-up of 4 weeks, which will examine in a dynamic clinical, biological and genetic aspects.

Description

Inclusion Criteria:

  • Patients with diagnostic (histological or cytological) evidence of locally advanced or metastatic solid tumour;
  • With average pain intensity > 4, measured with NRS and related to the last 24 hours, due to the cancer, requiring OXN for the first time;
  • With life expectancy > one month;
  • Strong opioid naïve;
  • Eligible to take any of the medications under evaluation;
  • With age ≥ 18 years.

Exclusion Criteria:

  • With presence of other diseases, including psychiatric/mental illness, severe senile or other form of dementia, that can interfere with participation and compliance with the study protocol or can contraindicate the use of the investigational drugs;
  • Diagnosis of primary brain tumor or leukaemia;
  • Diagnosis of chronic renal failure;
  • Patients with antalgic radiotherapy or radio-metabolic therapy in progress or completed less than 14 days before study;
  • Patients starting a first line chemotherapy simultaneously to the beginning of the study;
  • Other types of analgesic treatments, including local-regional anesthetic techniques or neurosurgical /ablative methods;
  • Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days
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".
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOL-IRFMN-6554

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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