OSTEOARTHRITIC PAIN OR CANCER RELATED PAIN IN THE ELDERLY PATIENT MedDRA version: 9.1 Level: SOC Classification code 10029104
Conditions
Interventions
Trade Name: TACHIDOL
Pharmaceutical Form: Effervescent granules
INN or Proposed INN: PARACETAMOLO
CAS Number: 103-90-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
FONDAZIONE PAOLO PROCACCI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - PATIENTS 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - TO EVALUATE EFFICACY AND TOLERABILITY OF OPIOIDS IN THE ELDERLY PATIENT - 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 | — |
Countries
Italy
Outcome results
None listed