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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. Identifier: NCT02293785
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : March 21, 2016
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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.

Condition or disease Intervention/treatment
Cancer Pain Neoplasms Drug: Oxycodone-Naloxone

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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".

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02293785

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IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, Italy
Ospedale degli Infermi di Biella
Biella, Italy, 13900
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
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research

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Responsible Party: Mario Negri Institute for Pharmacological Research Identifier: NCT02293785     History of Changes
Other Study ID Numbers: DOL-IRFMN-6554
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Cancer Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists