Cancer patients with locally advanced or metastatic solid tumor. MedDRA version: 9.1 Level: SOC Classification code 10029104
Conditions
Interventions
Trade Name: MORFINA
Pharmaceutical Form: Tablet
INN or Proposed INN: Morphine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: OSSICODONE CLORIDRATO
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.patients with diagnostic(histological or cytological) evidence of locally advanced or metastatic solid tumour; 2.with average pain intensity = 4, measured with NRS and related to the last 24 hours, due to the cancer, requiring for the first time an analgesic treatment with 3rd step/WHO opioids 3.with life expectancy > one month 4.“strong” opioid na?ve; 5.eligible to take any of the medications under evaluation, by TDS or by mouth; 6.with age = 18 years; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients recruited in other researches that conflict or may confound the conduction and results of the present study; 2.Lack of informed consent; 3.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; 4.with presence of co-morbidities, which could create potentially dangerous drug interactions with opioids (eg, use of macrolide antibiotics or antifungal); 5.any kind of contraindications to the use of opioid drugs; 6.Patients with a known story, past or current, of drugs abuse or addiction; 7.Use of drugs which presents a combination of opioids and other molecule (as NSAIDs, paracetamol, naloxone); 8.Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons; 9.Need of starting 3rd step treatment in an “emergency clinical situation” that do not allow the correct procedures of randomization; 10.diagnosis of primary brain tumor or leukaemia; 11.diagnosis of chronic renal failure; 12.patients with antalgic radiotherapy or radio-metabolic therapy in progress or completed less than 14 days before study; 13.patients starting a first line chemotherapy simultaneously to the beginning of the study; 14.other types of analgesic treatments, including local-regional anesthetic techniques or neurosurgical /ablative methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • The comparison of the analgesic efficacy of 4 treatment strategies based on 4 different strong opioids (oral morphine and oxycodone, transdermal fentanyl and buprenorphine) administered by randomization during a 4 weeks follow-up period, in patients with moderate to severe pain due to the cancer, measured at each visit by means of a NRS 0 to 10, and related to the average pain of the previous 24 hours.;Secondary Objective: • The evaluation of performance of the four opioids by means of the analysis of daily dose escalation (OEI%); the need of supplementary opioid doses finalized to support ATC treatment; the need of rescue therapy (due to BTcP treatment); the need of analgesic adjuvants finalized to support ATC therapy (and not to treat specific type of pain, such as neuropathic, bone, …); the need of switch in case of insufficient pain relief; the need of abandoning opioid therapy for unresponsiveness.;Primary end point(s): Evaluation of the proportion of Non-Responder (NR) patients. NRs correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity “stable” or “worsened” at day 28 compared with baseline values. | — |
Countries
Italy
Outcome results
None listed