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Symptomatic Management of Lyme Arthritis

Symptomatic Management of Lyme Arthritis

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04038346
Enrollment
3
Registered
2019-07-30
Start date
2019-10-01
Completion date
2025-05-12
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Lyme Arthritis, Lyme Disease

Keywords

Lyme Arthritis, Lyme, Lyme Disease, Arthritis, NSAID

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 treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing. It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms. The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.

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 calculations: The purpose of the research study is to evaluate whether there is symptomatic benefit of schedule NSAID therapy in patients with Lyme arthritis diagnosis. 1. Quantification of antibiotic-refractory Lyme arthritis in our population 2. Symptomatic outcomes of patients with Lyme arthritis on scheduled NSAIDs versus those not placed on scheduled NSAIDs (duration to resolution and number of patients with resistant arthritis) 3. Assess side effects of patients with Lyme arthritis placed on scheduled NSAIDs versus those not placed on scheduled NSAIDs 4. Assess changes in resources (follow-up visits, further prescriptions) required for patients taking scheduled NSAIDs versus not taking scheduled NSAIDs Background: Lyme disease is the systemic tick-borne disease caused by Borrelia burgdorferi infection, and is endemic to an expanding portion of the United States. Lyme arthritis is a common presentation of Lyme disease. While Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged inflammatory arthritis. Research suggests excessive up-regulation of the inflammatory process in patients with prolonged symptoms. The over-expressed pro- inflammatory cell mediators are downstream of NSAID inhibition, which would suggest NSAIDs may be beneficial in these patients. In fact, there is data that NSAIDs and/or disease-modifying anti-rheumatic drugs (DMARDs) may be beneficial in refractory Lyme arthritis cases, once diagnosed as refractory. The hypothesis of the study is that prescribing scheduled NSAIDs 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, or at least decrease the duration of persistent Lyme arthritis symptoms. There are no known methods to identify patients who will develop antibiotic-refractory Lyme arthritis. This work is important to delineate optimal timing and duration of NSAIDs given the research that shows the anti- inflammatory effects during healing can potentially delay recovery. Significance: While antibiotic-refractory Lyme arthritis has been studied at a microbiologic/cytokine level as well as evaluated in terms of treatment once patients have been deemed antibiotic refractory, to our knowledge there are no published studies evaluating prevention. With no literature looking at the question of NSAIDs for the prevention of antibiotic- refractory Lyme arthritis, this pilot study is needed to adequately calculate sample size and power calculations for a large-scale multicenter study. There is anecdotal data from the Rheumatology and Infectious Disease departments at the UPMC Children's Hospital of Pittsburgh that early scheduled NSAIDs may decrease refractory cases, but there has been no formal evaluation into this question. Retrospective evaluation is challenging since the medications in question (NSAIDs) are over the counter, and clinicians may recommend scheduled or intermittent NSAID therapy without documentation, and certainly without prescriptions in the medical record. Many patients with refractory Lyme arthritis are placed on NSAIDs, but given the question of delayed healing with inhibition of prostaglandins during the healing phase of inflammation, the question of whether NSAIDs are beneficial in patients to prevent refractory arthritis is worthwhile rather than the current process of variable NSAID prescription.

Interventions

DRUGNaproxen

Patients will be randomized to an NSAID (naproxen)

DRUGAcetaminophen

Patients will be randomized to acetaminophen

Sponsors

Desiree Neville, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, randomized, controlled, non blinded

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text SurveySymptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter yes to symptoms completely resolvedIf patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveysdays 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveysdays 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveysdays 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveysdays 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey

Secondary

MeasureTime frameDescription
Medication Compliance as Determined by Question in Serial Text Surveydays 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)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 the text survey- medication compliance will be compared to the number of doses that would be full compliance for that treatment arm
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Surveydays 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)survey asks parents to describe any medication side effects they feel their child has had - descriptive outcome only
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Surveydays 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)Parents are asked to list any medications in addition to their study drug and the prescribed antibiotic that their child has taken- descriptive outcome only
Number of Participants Who Reported Fever as Determined by Question in Serial Text Surveydays 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)Parents are asked if their child had fever in the 24 hours prior to taking the text survey

Other

MeasureTime frameDescription
Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame30 days, 60 days, 120 days, 1 yearMean repeat medical visits for Lyme arthritis will be compared between treatment arms based on medical record review

Countries

United States

Participant flow

Participants by arm

ArmCount
NSAID
Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)
1
Acetaminophen
Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen
2
NSAID First, Then Acetaminophen
Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen
0
Standard Care
Symptom observation only
0
Total3

Baseline characteristics

CharacteristicNSAIDAcetaminophenNSAID First, Then AcetaminophenStandard CareTotal
Age, Categorical
<=18 years
1 Participants2 Participants0 Participants0 Participants3 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Continuous9 years6 years7 years
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 10 / 20 / 00 / 0
other
Total, other adverse events
1 / 10 / 20 / 00 / 0
serious
Total, serious adverse events
0 / 10 / 20 / 00 / 0

Outcome results

Primary

Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys

0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey

Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected

Population: Not all text survey instances completed.

ArmMeasureGroupValue (MEAN)
NSAIDJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysEnrollment, Day 035 score on a scale
NSAIDJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 386 score on a scale
NSAIDJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 7100 score on a scale
NSAIDJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 21100 score on a scale
NSAIDJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 28100 score on a scale
NSAIDJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 150 score on a scale
AcetaminophenJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysEnrollment, Day 050 score on a scale
AcetaminophenJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 378 score on a scale
AcetaminophenJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 147 score on a scale
AcetaminophenJoint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text SurveysDay 1484 score on a scale
Primary

Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys

0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey

Time frame: days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected

Population: VAS score for pain across all groups

ArmMeasureGroupValue (MEAN)
NSAIDJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysEnrollment, Day 062 score on a scale
NSAIDJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 70 score on a scale
NSAIDJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 100 score on a scale
NSAIDJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 210 score on a scale
NSAIDJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 280 score on a scale
NSAIDJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 150 score on a scale
NSAIDJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 316 score on a scale
AcetaminophenJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysEnrollment, Day 058 score on a scale
AcetaminophenJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 326 score on a scale
AcetaminophenJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 149.5 score on a scale
AcetaminophenJoint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text SurveysDay 1420 score on a scale
Primary

Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys

0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey

Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected

Population: There was not 100% follow-up with text surveys

ArmMeasureGroupValue (MEAN)
NSAIDJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysEnrollment, Day 061 score on a scale
NSAIDJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 37 score on a scale
NSAIDJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 70 score on a scale
NSAIDJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 210 score on a scale
NSAIDJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 280 score on a scale
NSAIDJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 138 score on a scale
AcetaminophenJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysEnrollment, Day 020 score on a scale
AcetaminophenJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 319 score on a scale
AcetaminophenJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 122.5 score on a scale
AcetaminophenJoint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text SurveysDay 140 score on a scale
Primary

Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys

0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey

Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected

Population: Not all text surveys completed.

ArmMeasureGroupValue (MEAN)
NSAIDOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysEnrollment, Day 050 score on a scale
NSAIDOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 7100 score on a scale
NSAIDOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 10100 score on a scale
NSAIDOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 21100 score on a scale
NSAIDOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 28100 score on a scale
NSAIDOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 165 score on a scale
NSAIDOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 385 score on a scale
AcetaminophenOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysEnrollment, Day 050 score on a scale
AcetaminophenOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 389 score on a scale
AcetaminophenOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 155.5 score on a scale
AcetaminophenOverall Function Reported by Serial Visual Analog Scale for Overall Function Via Text SurveysDay 1483 score on a scale
Primary

Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey

If patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution

Time frame: Symptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter yes to symptoms completely resolved

Population: 3 enrolled patients - none of the acetaminophen patients continued until resolution

ArmMeasureValue (MEAN)
NSAIDTime to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey6 days since enrollment
Secondary

Medication Compliance as Determined by Question in Serial Text Survey

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 the text survey- medication compliance will be compared to the number of doses that would be full compliance for that treatment arm

Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: Randomized participants, report percentage of medication doses taken that were available. (while still reporting symptoms)

ArmMeasureGroupValue (MEAN)
NSAIDMedication Compliance as Determined by Question in Serial Text SurveyDay 7100 percentage of available med doses taken
NSAIDMedication Compliance as Determined by Question in Serial Text SurveyDay 10100 percentage of available med doses taken
NSAIDMedication Compliance as Determined by Question in Serial Text SurveyDay 3100 percentage of available med doses taken
NSAIDMedication Compliance as Determined by Question in Serial Text SurveyDay 1100 percentage of available med doses taken
AcetaminophenMedication Compliance as Determined by Question in Serial Text SurveyDay 3100 percentage of available med doses taken
AcetaminophenMedication Compliance as Determined by Question in Serial Text SurveyDay 175 percentage of available med doses taken
AcetaminophenMedication Compliance as Determined by Question in Serial Text SurveyDay 1425 percentage of available med doses taken
Secondary

Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey

Parents are asked if their child had fever in the 24 hours prior to taking the text survey

Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: All enrolled patients

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
NSAIDNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 0 (Enrollment)1 Participants
NSAIDNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 70 Participants
NSAIDNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 100 Participants
NSAIDNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 210 Participants
NSAIDNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 280 Participants
NSAIDNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 10 Participants
NSAIDNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 30 Participants
AcetaminophenNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 0 (Enrollment)0 Participants
AcetaminophenNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 30 Participants
AcetaminophenNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 11 Participants
AcetaminophenNumber of Participants Who Reported Fever as Determined by Question in Serial Text SurveyDay 140 Participants
Secondary

The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey

Parents are asked to list any medications in addition to their study drug and the prescribed antibiotic that their child has taken- descriptive outcome only

Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: randomized participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
NSAIDThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 70 Participants
NSAIDThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 10 Participants
NSAIDThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 30 Participants
NSAIDThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 100 Participants
NSAIDThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 210 Participants
NSAIDThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 280 Participants
AcetaminophenThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 140 Participants
AcetaminophenThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 30 Participants
AcetaminophenThe Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text SurveyDay 10 Participants
Secondary

The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey

survey asks parents to describe any medication side effects they feel their child has had - descriptive outcome only

Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: Randomized patients

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
NSAIDThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 280 Participants
NSAIDThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 100 Participants
NSAIDThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 210 Participants
NSAIDThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 10 Participants
NSAIDThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 30 Participants
NSAIDThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 71 Participants
AcetaminophenThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 10 Participants
AcetaminophenThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 140 Participants
AcetaminophenThe Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text SurveyDay 30 Participants
Other Pre-specified

Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame

Mean repeat medical visits for Lyme arthritis will be compared between treatment arms based on medical record review

Time frame: 30 days, 60 days, 120 days, 1 year

Population: All patients were analyzed for return visits by: 30 days, 60 days, 120 days, 1 year

ArmMeasureGroupValue (MEAN)
NSAIDNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame30 days0 return visits for Lyme arthritis symptom
NSAIDNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame60 days0 return visits for Lyme arthritis symptom
NSAIDNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame120 days0 return visits for Lyme arthritis symptom
NSAIDNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame1 year0 return visits for Lyme arthritis symptom
AcetaminophenNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame1 year0 return visits for Lyme arthritis symptom
AcetaminophenNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame30 days0 return visits for Lyme arthritis symptom
AcetaminophenNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame120 days0 return visits for Lyme arthritis symptom
AcetaminophenNeed for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame60 days0 return visits for Lyme arthritis symptom

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026