OPIOIDS IN THE ELDERLY PATIENT: OSTEOARTHRITIC PAIN VERSUS CANCER RELATED PAIN. - OPIOIDS IN THE ELDERLY PATIENT.

Conditions: OSTEOARTHRITIC PAIN OR CANCER RELATED PAIN IN THE ELDERLY PATIENT
MedDRA version: 9.1Level: SOCClassification code 10029104

Registration Number: EUCTR2009-017357-35-IT

Lead Sponsor: FONDAZIONE PAOLO PROCACCI ONLUS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- MALE OR FEMALE PATIENTS OVER 75 YEARS OLD WITH A CONFIRMED DIAGNOSIS OF MODERATE-TO-SEVERE OSTEOARTHRITIC PAIN OR CANCER RELATED PAIN (NRS-NUMERICAL RATING SCALE- ≥ 4)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

- PATIENTS < 75 YEARS OLD
- PATIENTS IN TREATMENT WITH WEAK OR STRONG OPIOIDS
- PATIENTS WITH HYPERSENSITIVITY TO PARACETAMOLO OR OPIOIDS ANALGESICS
- PATIENTS WITH RENAL FAILURE (creatinine >1,8 mg/dl or creatinine clearance <30 ml/min
- PATIENTS WITH SEVERE HEPATIC DYSFUNCTION (serum albumin <25 g/l or Child-Pugh score ≥10)
- PATIENTS WITH SEVERE CARDIORESPIRATORY, METABOLIC OR INTESTINAL DISEASES
- PATIENTS WITH OPIOIDS DEPENDENCE
- EVIDENCE OR HISTORY OF ALCOHOL OR DRUG ABUSE
- PATIENTS IN TREATMENT WITH MAO-INHIBITORS IN THE LAST 2 WEEKS
- PSYCHIATRIC ILLNESS

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - TO EVALUATE EFFICACY AND TOLERABILITY OF OPIOIDS IN THE ELDERLY PATIENT <br>- TO COMPARE EFFICACY AND TOLERABILITY OF OPIOIDS IN OSTEOARTHRITIC PAIN VERSUS CANCER RELATED PAIN;Secondary Objective: NO;Primary end point(s): TO EVALUATE NUMBER OF PATIENTS RESPONDER TO ANALGESIC THERAPY. RESPONDER IS THE PATIENT WHO SHOWS A PAIN RELIEF ≥ 30% IN THE PAIN INTENSITY SCALE NRS IN THE STABLE PHASE OF THERAPY WIYH A RESCUE MEDICATION`S CONSUM ≤3

Secondary Outcome Measures