GREAT - Good Response With Appropriate Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02293785
• Date of registration: 13/11/2014
• Prospective Registration: No
• Primary sponsor: Mario Negri Institute for Pharmacological Research
• Public title: GREAT - Good Response With Appropriate Treatment
• Scientific title: GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"
• Date of first enrolment: November 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02293785
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasms

Cancer Pain

Intervention(s)

Drug: Oxycodone-Naloxone

Primary Outcome(s)

non responders [Time Frame: 28 days]

Secondary Outcome(s)

additional opioid treatment [Time Frame: 28 days]

Opioids Escalation Index [Time Frame: 28 days]

Secondary ID(s)

DOL-IRFMN-6554

Source(s) of Monetary Support

Please refer to primary and secondary sponsors