NCT02293785

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

Completed Last updated 18 March 2016

What this trial tests

trial testing Oxycodone-Naloxone in Cancer Pain in 200 participants. Completed in 1 February 2016.

Timeline

1 November 2014

Primary endpoint
1 February 2016

1 February 2016

Quick facts

Lead sponsor	Mario Negri Institute for Pharmacological Research
Status	Completed
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 November 2014
Primary completion	1 February 2016
Estimated completion	1 February 2016
Sites	18 locations across Italy

Drugs / interventions tested

• Oxycodone-Naloxone — full drug profile →

Conditions studied

• Cancer Pain — all drugs for Cancer Pain →
• Neoplasms — all drugs for Neoplasms →

Sponsor

Mario Negri Institute for Pharmacological Research

Who can join

18 and older, any sex, with Cancer Pain or Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A comparison between the administration of oral prolonged-release oxycodone-naloxone and transdermal fentanyl in patients with moderate-to-severe cancer pain: a propensity score analysis.
   Roberto A, Greco MT, Legramandi L, Galli F, et al · · 2017 · cited 5× · PMID 28919810 · DOI 10.2147/jpr.s141928