Multicenter, not-for-profit study to evaluate tolerability, safety of tramadol once-a-day in older patients with dementia and difficulty to verbalize - NPTRAM1108
- Conditions
- Pain in older patients with dementiaMedDRA version: 9.1Level: LLTClassification code 10050533Term: Pain assessmentMedDRA version: 9.1Level: LLTClassification code 10000428Term: Ache NOS
- Registration Number
- EUCTR2008-007405-37-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Age ≤75 years
A diagnosis of dementia of any type
Difficulty to verbalize
Persistent pain as testified by a score >5 at the DOLOPLUS-2 scale
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
Participation to other studies in the last 3 months
Refuse or inability to give consent
Terminal state
On an analgesic medication for over 1 month
Clinical evidence suggesting an acute pain condition of any intensity
Contraindication to tramadol once-a-day
Epilepsy or current pharmacologic treatment with carbamazepine
Juvenile intellectual disability
Concomitant treatment with MAO inhibitors
Presence of any disease or condition which at investigators? judgment might interfere with the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy ? pain intensity, pain interference, pain relieve, physical performance, functional status;Secondary Objective: Tolerability - blood pressure, creatinine clearance, anemia, adverse events;Primary end point(s): Efficacy ? pain intensity, pain interference, pain relieve, physical performance, functional status
- Secondary Outcome Measures
Name Time Method