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

• Conditions: non neoplastic cronic pain; MedDRA version: 9.1Level: PTClassification code 10033371Term: Pain; MedDRA version: 9.1Level: PTClassification code 10050819Term: Musculoskeletal chest pain

• Registration Number: EUCTR2008-003596-46-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

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

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 (<3 months) surgery
Recent (< 3 months) myocardial infarction
Recent (< 3 months) stroke
Recent (< 3months) thrombolytic treatment
History of GI bleeding
Previous cerebral hemorrhage
Hematologic or hemorrhagic disease
Severe anemia (Hb <10 gr/dl) in the last 3 months
Renal insufficiency (creatinine level > 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

Study & Design

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