Completed

CERPRCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.

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What is being tested

Morphine

+ Oxycodone

+ Buprenorphine

Drug
Who is being recruted

Neurologic Manifestations+3

+ Pain

+ Signs and Symptoms

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorMario Negri Institute for Pharmacological Research
Last updated: December 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life of patients and a high incidence, with values around 70-90% in advanced and metastatic stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are the guidelines produced by the World Health Organization (WHO). This document shows that the use of opioid drugs is the mainstay of treatment, with particular reference to opioids "major" (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the data currently available, have an analgesic effect would partly overlap but with different percentages of non-responders (NR), a different need to increase the dose over time to maintain adequate analgesia, a different action to the switch to another molecule for ineffectiveness analgesic. The observations described suggest that opioids, although they belong to the same family drug may not be fully comparable with regard to the clinical effects products. Important differences are known on the pharmacokinetic and pharmacodynamic and, more recently, also in terms of pharmacogenomics. This is a comparative study of analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible differences in terms of analgesic efficacy, changes in dose over time, use of switch or permanent abandonment of treatment, parallel to the contour of the side effects. The associated sub-project will link the structure gene of patients and clinical results have emerged.

Principal SponsorMario Negri Institute for Pharmacological Research
Last updated: December 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

518 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsCancer PainNeoplasms

Criteria

6 inclusion criteria required to participate
eligible to take any of the medications under evaluation, by TDS or by mouth

patients with diagnostic (histological or cytological) evidence of locally advanced or metastatic solid tumour

strong" opioid naïve

with age >= 18 years

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14 exclusion criteria prevent from participating
Lack of informed consent

Need of starting 3rd step treatment in an "emergency clinical situation" that do not allow the correct procedures of randomization

Patients recruited in other researches that conflict or may confound the conduction and results of the present study

Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Ospedale S. Marta

Catania, ItalyOpen Ospedale S. Marta in Google Maps

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Italy

Istituto Scientifico San Raffaele

Milan, Italy

Azienda Ospedaliera Valtellina-Valchiavenna

Morbegno, Italy
Completed9 Study Centers