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Nonsteroidal Anti-inflammatory Drug

NSAIDs for Lyme Arthritis

Phase 3
Recruiting
Led By Desiree NW Neville, MD
Research Sponsored by Desiree Neville, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Awards & highlights

Study Summary

This trial is testing whether or not giving NSAIDs to patients with Lyme arthritis at the time of diagnosis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include digestive issues like stomach pain from Naproxen and potential liver damage from excessive Acetaminophen use. Allergic reactions may occur in sensitive individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in degree of joint movement determined by serial visual analog scale for joint movement via text surveys
Change in degree of overall function determined by serial visual analog scale for overall function via text surveys
Change in the degree of joint pain determined by serial visual analog scale for pain via text surveys
+2 more
Secondary outcome measures
Change in medication compliance as determined by question in serial text survey
Development of medication side effects as determined by question in serial text survey
Fever as determined by question in serial text survey
+1 more
Other outcome measures
Need for further care as determined by medical record review as number of visits in the system for Lyme arthritis symptoms

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
2019
Completed Phase 4
~31530
Acetaminophen
2017
Completed Phase 4
~2030

Find a Location

Who is running the clinical trial?

Desiree Neville, MDLead Sponsor
Desiree NW Neville, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Acetaminophen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04038346 — Phase 3
Lyme Arthritis Research Study Groups: Standard Care, NSAID, Acetaminophen, NSAID first, then Acetaminophen
Lyme Arthritis Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT04038346 — Phase 3
Acetaminophen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038346 — Phase 3
Lyme Arthritis Patient Testimony for trial: Trial Name: NCT04038346 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include elderly patients?

"Children aged 3 to 17 years old who meet the other eligibility requirements can participate in this clinical trial. Out of the 4,280 active clinical trials, 87 are for people under 18 and 397 are for patients over 65."

Answered by AI

Who would be most likely to provide helpful results in this clinical trial?

"To take part in this clinical trial, patients must have lyme arthritis and be between the ages of 3 and 17. A total of 300 patients will be enrolled in the study."

Answered by AI

What types of pain does Acetaminophen help to manage?

"Acetaminophen is the recommended treatment for catarrh. However, it can also be used to mitigate the symptoms of other conditions like rhinorrhoea, seasonal allergic rhinitis, and musculoskeletal pain."

Answered by AI

What are the dangers of Acetaminophen?

"Acetaminophen is estimated to be a safe medication, as it has Phase 3 clinical trial data to support both its efficacy and safety."

Answered by AI

How many research subjects will this trial be testing?

"Yes, this is an active trial according to the latest information from clinicaltrials.gov. The listing for the study was created on October 1st, 2019 and was last edited on November 9th, 2021. They are looking for 300 patients from 1 location."

Answered by AI

Are there other drugs that have been tested in similar ways to Acetaminophen?

"Acetaminophen is being trialled in 105 different clinical studies, with 31 of those in the advanced Phase 3 stage. Although a majority of the research is based in Evanston, Illinois, there are over a thousand other locations conducting these trials."

Answered by AI

Are there any positions available for enrollees in this clinical trial?

"The information displayed on clinicaltrials.gov affirms that this trial is still enrolling patients. The trial was first posted on October 1st, 2019 and was updated as recently as November 9th, 2021. So far, 300 individuals have been recruited from a single location."

Answered by AI

What are the goals of this particular clinical research project?

"The primary goal of this study is to monitor the change in joint pain in patients via serial visual analog scale for pain via text surveys. Secondary objectives include Fever as determined by question in serial text survey which is defined as Parents are asked if their child had fever in the 24 hours prior to taking the text survey, duration of fever compared between treatment arms, Change in medication compliance as determined by question in serial text survey which is defined as Parents enter number of days patient has taken the medication in the past day as well as per day since the last survey in two questions on the text survey with their response being a drop down number list on"

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Mississippi
Kansas
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How old are they?
18 - 65
What site did they apply to?
Children's Hospital of Pittsburgh of UPMC
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I was diagnosed with having Lyme disease about two years ago which was long standing and probably contracted around 30 years previous during my time living in Upstate New York. I have had life long joint and muscle pain, multiple rounds of physical therapy, treatment with doxycycline, and have had three joint replacements. I am currently being tested for other conditions by a rheumatologist, but strongly believe the Lyme disease is chronic and the primary cause of severe arthritis.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Symptomatic Management of Lyme Arthritis
Desiree Neville, MD 2019. "Symptomatic Management of Lyme Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038346.
All > Lyme Disease > Arthritis
~153 spots leftby Dec 2028
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