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Lyme arthritis pain study halted early – what we know

NCT ID NCT04038346

Symptom relief Sponsor: Desiree Neville, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if taking NSAIDs (like naproxen) on a regular schedule could reduce arthritis symptoms and prevent long-term joint problems in people with Lyme disease. Only 3 participants were enrolled before the study was stopped, so no clear conclusions can be drawn. The approach was to compare scheduled NSAIDs, acetaminophen, or a switch from NSAIDs to acetaminophen after one week.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3 people

The number who actually took part.

Started

Oct 2019

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Arthritis * Undergoing Lyme disease testing (Lyme test positive) Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

arthritic joint disease Lyme disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis Lyme arthritis Lyme disease

Contacts and locations

Locations

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.