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Multicenter, not-for-profit clinical study, in a open, controlled, randomized fashion to compare tolerability, safety and efficacy of two different treatment strategies for non malignant, persistent pain in older patients - NPTRAM0108

Multicenter, not-for-profit clinical study, in a open, controlled, randomized fashion to compare tolerability, safety and efficacy of two different treatment strategies for non malignant, persistent pain in older patients - NPTRAM0108

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003596-46-IT
Enrollment
Unknown
Registered
2008-10-08
Start date
2009-02-25
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

non neoplastic cronic pain MedDRA version: 9.1 Level: PT Classification code 10033371 Term: Pain MedDRA version: 9.1 Level: PT Classification code 10050819 Term: Musculoskeletal chest pain

Interventions

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age between 60 and 75 years Persistent pain (≥ 3 months) of non-malignant etiology Median pain intensity in the last 7 days at least moderate 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: Participation to other studies in the last 3 months Severe cognitive deterioration Refuse or inability to give consent Active cancer diagnosis On an analgesic medication for over 1 month Recent ( 1.5 mg/dl) Dialysis or kidney transplantation Recent (< 3 months) urinary retention Heart failure (NYHA class III-IV) Psychiatric disease Chronic hepatitis Respiratory failure (stadio GOLD II-III) Allergies or intolerance to study drugs Epilepsy or epileptic medications

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary ? comparative tolerability and safety of NSAIDs and tramadol once-a-day (OAD);Secondary Objective: comparative efficacy of NSAIDs and tramadol OAD;Primary end point(s): comparative tolerability and safety of NSAIDs and tramadol once-a-day (OAD)

Countries

Italy

Outcome results

None listed

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