Multicentric, no-profit, open, controlled randomized clinical study to evaluate comparable tolerability and efficacy of two pharmacological treatments for persistent, non oncological pain in the elderly - ND

• Conditions: persistent non oncological pain; Level: PTClassification code 10033371

• Registration Number: EUCTR2006-001833-16-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age ≥70 anni
- Persistent pain (≥ 3 months) of musculo-skeletal origin
- Pain intensity from moderate to severe
- Able to read, understand and give inform consent
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

- participation to other clinical studies in the last 3 months
- severe cognitive deterioration
- unable to give inform consent
- active diagnosis of cancer
- daily use of analgesics over the last month
- surgery less than 3 months earlier
- myocardial infarction or acute coronary syndrome less than 3 months earlier
- stroke less than 3 months earlier
- recent thrombolytic treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary: comparable tolerability of nonsteroidal anti-inflammatory agents and of a fixed formulation of rapid release oxycodone and paracetamol.;Secondary Objective: Secondary: comparable efficacy of nonsteroidal anti-inflammatory agents and of a fixed formulation of rapid release oxycodone and paracetamol;Primary end point(s): ND