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sing drugs to treat pain in hand arthritis

Phase 1
Conditions
Hand osteoarthritis
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Registration Number
EUCTR2011-003803-39-GB
Lead Sponsor
St George's University of London
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
45
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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