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NSAIDs for Lyme Arthritis

Recruiting in Palo Alto (17 mi)

Overseen byDesiree NW Neville, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Desiree Neville, MD

Must not be taking: Daily NSAIDs, Daily acetaminophen

Disqualifiers: Rheumatoid arthritis, Kidney impairment, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if taking anti-inflammatory drugs regularly can help prevent long-term joint problems in people with Lyme disease. It focuses on patients who don't get better with antibiotics. The drugs work by reducing inflammation, which might stop the prolonged symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are already taking daily NSAIDs or acetaminophen, you cannot participate. If you have any hypersensitivity to naproxen or acetaminophen, you should not take the study medications.

What evidence supports the effectiveness of the drug naproxen for treating Lyme arthritis?

Research shows that naproxen, a type of anti-inflammatory drug, is effective in relieving pain for conditions like rheumatoid arthritis, which is similar to Lyme arthritis. It was found to provide significant pain relief and was preferred by patients in studies comparing it to other pain relievers.¹ ² ³ ⁴ ⁵

Is naproxen sodium safe for general use?

Naproxen sodium is generally safe for over-the-counter use, with most people experiencing no adverse effects. Common side effects include headache, nausea, and drowsiness, but these occur at similar rates to a placebo. However, it can cause stomach issues, allergic reactions, and liver problems, and should be avoided by people with heart failure or high blood pressure.⁶ ⁷ ⁸ ⁹ ¹⁰

How does the drug Acetaminophen and Naproxen differ from other treatments for Lyme Arthritis?

Acetaminophen and Naproxen are used for their pain-relieving and anti-inflammatory effects, with Naproxen being a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain, while Acetaminophen primarily relieves pain and reduces fever. This combination may offer a balanced approach to managing symptoms of Lyme Arthritis, especially for patients who cannot tolerate other anti-inflammatory drugs like aspirin.³ ¹¹ ¹² ¹³ ¹⁴

Research Team

Desiree NW Neville, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals with Lyme arthritis who are testing positive for Lyme disease. It's not suitable for those with rheumatoid or recurrent arthritis, on daily NSAIDs or acetaminophen, have severe liver issues, a history of allergic reactions to NSAIDs, or underlying kidney or liver impairment.

Inclusion Criteria

Undergoing Lyme disease testing (Lyme test positive)

I have arthritis.

Exclusion Criteria

Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative

I am allergic to naproxen, aspirin, or have had bad reactions to NSAIDs.

I am allergic to acetaminophen or have severe liver problems.

See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive scheduled NSAIDs, acetaminophen, or NSAIDs followed by acetaminophen to manage Lyme arthritis symptoms

8 weeks

Regular text surveys on days 1, 3, 7, 10, 14, 21, 28, 60

Follow-up

Participants are monitored for safety and effectiveness after treatment, including symptom resolution and side effects

4 weeks

Follow-up visits as needed based on symptom resolution

Long-term Follow-up

Participants' need for further care and medication compliance are assessed over an extended period

1 year

Treatment Details

Interventions

Acetaminophen (Nonsteroidal Anti-inflammatory Drug)
Naproxen (Nonsteroidal Anti-inflammatory Drug)

Trial OverviewThe study tests if scheduled use of the anti-inflammatory drug Naproxen, pain reliever Acetaminophen, or a combination can prevent prolonged symptoms in Lyme arthritis. Patients will be randomly assigned to one of these treatments and monitored for symptom duration and treatment side effects.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: NSAID first, then AcetaminophenExperimental Treatment2 Interventions

Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve

Group II: NSAIDExperimental Treatment1 Intervention

Naproxen at weight based standard dose given bid daily until symptoms resolve

Group III: Standard CareActive Control1 Intervention

Symptom observation only

Group IV: AcetaminophenActive Control1 Intervention

Acetaminophen at weight based standard dose given qid until symptoms resolve

Acetaminophen is already approved in Canada for the following indications:

Approved in Canada as Tylenol for:

Pain relief
Fever reduction

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Children's Hospital of Pittsburgh of UPMCPittsburgh, PA

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Who Is Running the Clinical Trial?

Desiree Neville, MD

Lead Sponsor

Trials

Patients Recruited

300+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European experience with flurbiprofen. A new analgesic/anti-inflammatory agent.Buchanan, WW., Kassam, YB.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative trial of benoxaprofen and naproxen.Highton, J., Grahame, R.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug therapy reviews: antirheumatic agents.Evens, RP.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the analgesic effect of ten nonsteroidal anti-inflammatory drugs.Isomäki, H., Martio, J., Kaarela, K., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracetamol for the management of pain in inflammatory arthritis: a systematic literature review.Hazlewood, G., van der Heijde, DM., Bombardier, C.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of over-the-counter naproxen sodium.DeArmond, B., Francisco, CA., Lin, JS., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen sodium.Sutton, LB.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine.Winner, P., Cady, RK., Ruoff, GE., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen: pharmacology and dental therapeutics.Roda, RS.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicological effect of Artemisinin-Based Combination Therapies plus Paracetamol in malaria patients.Aghahowa, SE., Ozolua, RI., Bafor, EE., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of Butacote and Naprosyn in ankylosing spondylitis.Ansell, BM., Major, G., Liyanage, SP., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dipyrone elicits substantial inhibition of peripheral cyclooxygenases in humans: new insights into the pharmacology of an old analgesic.Hinz, B., Cheremina, O., Bachmakov, J., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different mechanisms underlie the analgesic actions of paracetamol and dipyrone in a rat model of inflammatory pain.Rezende, RM., França, DS., Menezes, GB., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long and winding road of non steroidal antinflammatory drugs and paracetamol in cancer pain management: a critical review.Mercadante, S., Giarratano, A.[2018]