Status:
COMPLETED
Timed Release Tablet Prednisone in Polymyalgia Rheumatica
Lead Sponsor:
University Hospitals Bristol and Weston NHS Foundation Trust
Conditions:
Polymyalgia Rheumatica
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
PHASE3
Brief Summary
Polymyalgia Rheumatica (PMR) is a disease that usually affects older people. Patients complain of stiffness and pain around the shoulders and hips. The stiffness is more severe in the morning. Resear...
Detailed Description
The volunteers will stay overnight in the Rheumatology Centre; 24-hour Research Facility on two occasions (Night A and Night B) 12-16 days apart. This slight flexibility will allow some leeway in arra...
Eligibility Criteria
Inclusion
- Diagnosis of PMR by standard criteria. The Bird criteria will be used. 3 or more features are required to make the diagnosis.
- Bilateral shoulder pain/stiffness
- Duration of symptoms \<2/52
- Initial ESR \>40 mm/h
- Stiffness \>1 h
- Age \>65 years
- Depression and/or weight loss
- Bilateral upper arm tenderness
- Are over 50 but less than 85 years old.
- No or stable NSAID or analgesic therapy for at least 7 days.
- Currently active disease defined by a CRP at least 10mg/L, ESR at least 29mm in one hour or PV \>1.72
Exclusion
- Currently on oral glucocorticoid treatment or taken within 2 months
- Parenteral glucocorticoid treatment with the last 2 months
- Pregnancy and lactation
- Inflammatory diseases such as inflammatory bowel disease, colitis, asthma
- Co-existent giant cell arteritis
- Other auto-immune diseases
- Cancer
- Infections, treatment with antibiotics within the past 6 weeks
- Significant renal disease (creatinine \>150 μmol/L)
- Significant hepatic impairment
- Participation in a clinical trial within the past 30 days
- Working shift employee
- Jet lag
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00836810
Start Date
October 1 2009
End Date
March 1 2011
Last Update
September 13 2022
Active Locations (1)
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1
University Hospitals Bristol NHS Trust
Bristol, Avon, United Kingdom, BS2 8HW