EUCTR2011-003803-39-GB
Active, not recruiting
Phase 1
Pain management in osteoarthritis using the centrally acting analgesics duloxetine and pregabalin - Pain management in osteoarthritis using centrally acting analgesics (DUPRO)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hand osteoarthritis
- Sponsor
- St George's University of London
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants fulfilling: 1\.the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis, 2\.right or left \-handed 3\.male or female 4\.aged 40\-75 5\.On usual care for hand osteoarthritis including paracetamol and/or NSAIDs
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 35
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •1\. other rheumatological diagnosis e.g. rheumatoid arthritis 2\. current or planned pregnancy 3\. contraindications to duloxetine or pregabalin such as MAOI, SSRI, antidepressants, oral contraceptives, St John’s wort 4\. history of depression 5\. concomitant use of opioids including tramadol and pethidine 6\. recent surgery i.e \< 6 weeks prior to participation in the study 7\. recent insertion of surgical implants i.e. less than 6 weeks before participation prior to entry 8\. Previous use of duloxetine and/or pregabalin 9\. uncontrolled hypertension 10\. eGFR \< 60 ml/min 11\. hepatic impairment defined as ALT \> 2\.5 X ULN within 6 weeks of last clinical assessment 12\. ischaemic heart disease 13\. diabetes mellitus 14\. regular use of alcohol or alcohol abuse(maximum limits are 28 units/week for men and 21 units/ week for women) 15\. lactose intolerance
Outcomes
Primary Outcomes
Not specified
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