GREAT - Good Response With Appropriate Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Pain Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Oxycodone-Naloxone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No