Status:
TERMINATED
Symptomatic Management of Lyme Arthritis
Lead Sponsor:
Desiree Neville, MD
Conditions:
Lyme Arthritis
Lyme Disease
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and tr...
Detailed Description
Specific Aims: 1. Demonstrate feasibility to ensure adequate patient enrollment and symptomatic follow-up of patients with Lyme arthritis. 2. Develop pilot data necessary for sample size and power ca...
Eligibility Criteria
Inclusion
- Arthritis
- Undergoing Lyme disease testing (Lyme test positive)
Exclusion
- Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative.
- Underlying diagnosis of rheumatoid or recurrent arthritis Already on scheduled NSAIDs
- Anything that restricts the prescription of naproxen or acetaminophen:
- Hypersensitivity to naproxen (for example: anaphylactic reactions, serious skin reactions) or any component of the formulation; history of aspirin induced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, underlying kidney or liver impairment
- Already taking daily NSAIDs (naproxen or ibuprofen) or daily acetaminophen
- Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04038346
Start Date
October 1 2019
End Date
May 12 2025
Last Update
November 17 2025
Active Locations (1)
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1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224