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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001833-16-IT
Enrollment
Unknown
Registered
2009-11-06
Start date
2006-07-13
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

persistent non oncological pain Level: PT Classification code 10033371

Interventions

Trade Name: DEPALGOS Pharmaceutical Form: Film-coated tablet CAS Number: 124-90-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- CAS Number: 103-90-2 Concentrat

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026