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Knee OsteoarthritisPhase 3SKOAPNCT04504812

A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain

A Phase 3 study testing Duloxetine, Intra-Articular Injection and Nerve Procedure with long acting blocks in people with Knee Osteoarthritis, run by Johns Hopkins University at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Duloxetine, Intra-Articular Injection and Nerve Procedure with long acting blocks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,937 participants
Where
24 sitesUnited States
Study dates
1 Feb 2021to 8 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Knee pain score of ≥4 and ≤ 9 on the Modified 4-Item BPI Pain Scale at pre-intervention screening
  • Meets at least 1 of the 3 American College of Rheumatology (ACR) Classification criteria for knee osteoarthritis.
  • ACR criteria are:
  • At least three of the following using history and physical examination: age >50 years old; morning stiffness <30 minutes; crepitus on knee motion; bony tenderness; bony enlargement; no palpable warmth
  • At least one of the following using history, physical examination, and radiographic findings + the presence of osteophytes: age >50 years old; morning stiffness <30 minutes; crepitus on active motion and osteophytes
  • At least 5 of the following using history, physical examination, and laboratory findings: age >50 years old; morning stiffness <30 minutes; crepitus on knee motion; bony tenderness; bony enlargement; no palpable warmth; erythrocyte sedimentation rate (ESR) <40 mm/hour; Rheumatoid Factor (RF) <1:40; synovial fluid signs of osteoarthritis

Who cannot join

  • <18 years of age
  • Any inability to complete study procedures, including, but not limited to inadequate resources to mitigate low English language literacy
  • Refusal of randomization
  • Knee pain exclusions: Pain during an average of < 4 days per week over the past 3 months; pain in the index knee from a joint disease other than OA (e.g., infectious arthritis, rheumatoid arthritis, spondyloarthropathy)
  • Medication exclusions: Report changes in analgesic medication dose within 2 weeks of baseline; oral morphine equivalent dose of > 90 mg/d at baseline
  • Medical condition exclusions: Severe vision or hearing impairment or any signs of cognitive impairment that would prevent comprehension of consent procedures, study measures, or procedures; unstable medical condition that presents an absolute or relative contraindication for participation in both arms (e.g., unstable angina, congestive heart failure); poorly controlled serious psychiatric condition that could prevent full participation or affect outcomes (e.g., suicidal ideation, active psychosis, poorly controlled depression, active substance abuse [excluding tobacco, caffeine or moderate alcohol use])
Show all 18Show fewer
  • Knee-specific medical condition exclusions: History of bilateral knee joint replacement arthroplasty total knee arthroplasty (TKA) or TKA in the affected knee; partial replacements may be eligible depending on physician judgment; scheduled joint replacement; history of unilateral TKA and complaints of KOA pain limited to the operated knee; Intra-articular viscosupplementation, steroid injection or arthroscopic surgery in the index knee within 12 weeks of baseline
  • Pregnancy by self-report, report of intention to become pregnant (Phase 1), or as determined by urine pregnancy screening (if Standard of Care at site) (Phase 2). Due to the unknown effects of duloxetine on the developing fetus and newborn, and the potential harms of fluoroscopy in pregnancy, women who are pregnant or lactating or intend to get pregnant will not be included in this study. Those of childbearing potential will be asked to use reliable contraception during the course of their participation in the study and to notify the study team if they become pregnant during participation. Definition of reliable birth control will be defined as: Female and male sterilization (female tubal ligation or occlusion, male vasectomy); long-acting reversible contraceptives (LARC) methods (intrauterine devices, hormonal implants); short-acting hormonal methods (pill, mini pills, patch, shot, vaginal ring); barrier methods (condoms, diaphragms, sponge, cervical cap)
  • Phase 1 specific Exclusion Criteria- An individual who meets any of the following criteria will be excluded from participation in Phase 1 of this study and will be enrolled and randomized directly into Phase 2:
  • Known allergic reaction or medical condition that renders an individual unsuitable for Phase 1 study interventions, including closed-angle glaucoma, kidney disease (creatinine clearance < 30 mL/ min), severe liver disease, known adverse reaction to duloxetine or another selective serotonin-norepinephrine reuptake inhibitor (SNRI), bipolar disorder or mania, high likelihood of drug interactions that could lead to side effects (e.g., serotonin syndrome in people on multiple drugs that inhibit serotonin reuptake including monoamine oxidase (MAO) inhibitors).
  • Report failed trial of an adequate dose of duloxetine to relieve KOA symptoms over a 1-month period
  • Have tried and failed two of the following: NSAIDS, physical therapy (there are many physical therapies so clinicians should exercise their judgment as to what constitutes 'failed' therapy), or weight loss (need determined by clinician) and refuses participation in Phase 1
  • End-stage renal disease
  • Unreliable access to the internet on a daily basis, i.e., sufficient access to participate in the study and may include public library access, cafe/coffee shop spaces, access to a friend or neighbor's wifi or hotspot, etc. (reliability determined on a site-by-site basis)
  • Phase 2 specific exclusion criteria- An individual who meets any of the following is excluded from sequential participation in Phase 1 and then Phase 2, and will instead be randomized as a "solo" recruit into Phase 1:
  • Inability to pay for interventions (insurance or otherwise)
  • Medical condition exclusions: Untreated coagulopathy that could interfere with Phase 2 interventions; for automated implantable cardioverter-defibrillator that cannot be disabled before radiofrequency ablation (RFA), the investigator can consult cardiology, bioengineering or the device manufacturer before enrolling in phase 2 (i.e. not a definite exclusion criterion)
  • Knee specific medical condition exclusions: Current local infection in the knee; ulcers or an open wound in the region of the index knee; underwent an adequate trial of any Phase 2 procedural study intervention in the study knee; severe needle phobia that cannot be addressed pharmacologically

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Walter Reed Army Medical Center

    Bethesda, Maryland, 20889

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02199

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland VA Medical Center

    Cleveland, Ohio, 44106

  • University Hospitals

    Cleveland, Ohio, 44106

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • University of Florida

    Gainesville, Florida, 32608

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Weill Cornell University

    New York, New York, 10019

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of Rochester Medical Center

    Rochester, New York, 14623

  • University of California Davis

    Sacramento, California, 95817

  • University of Utah

    Salt Lake City, Utah, 84108

  • University of California San Diego

    San Diego, California, 92037

  • VA Medical Center San Diego

    San Diego, California, 92161

  • University of Washington

    Seattle, Washington, 98185

  • Wake Forest University

    Winston-Salem, North Carolina, 27517

Other trials in United States

About this study

There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.

Read the detailed description

Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability worldwide, affecting over 30% of older adults. It represents a major global health and economic burden to individuals and society. The rates of KOA have more than doubled in the past 70 years and continue to grow sharply, given increases in life expectancy and population body mass index (BMI). Surgery is often employed to treat KOA, but it is associated with a high rate of persistent pain, and is not a permanent solution. Numerous nonsurgical therapies have been advocated to treat pain in patients with KOA yet are not often used in clinical care. The limited pain relief and functional improvement seen in a subset of knee OA sufferers has led to a high rate of opioid use and disability in this population. The overarching goal of this study is to conduct a sequential parallel group randomized controlled trial (RCT) to evaluate the comparative effectiveness of conservative behavioral and non-opioid pharmacological treatments (Phase 1) and, among those that indicate interest in obtaining further treatment and those not eligible for conservative treatment, the benefits of procedural interventions (Phase 2). This study will also evaluate whether clinical and psychosocial phenotypes predict short- and longer-term treatment response. The results of this study will examine the effectiveness of each tested intervention and provide meaningful information regarding effectiveness across key subgroups of participants.

Being tested
Duloxetine, Intra-Articular Injection, Nerve Procedure with long acting blocks, Nerve Procedure with nerve ablation, Pain Coping Skills Training
Keywords
osteoarthritis, duloxetine, painTRAINER, hyaluronic acid injection, genicular nerve block, radiofrequency ablation
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuloxetineDrug

    Also called Cymbalta

    Duloxetine is a drug that is used to improve pain and function in people with knee osteoarthritis (KOA). Duloxetine is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety disorder, fibromyalgia, and joint pain. It will be titrated up from 20 or 30mg according to a schedule provided by a study provider.

  • Intra-Articular InjectionCombination product

    Intra-Articular Injection is an injection of 3-6 milliliter (mL) hyaluronic acid (HA) mixed with 1 milliliter (mL) depo methylprednisolone (a steroid) and 2 mL 0.5% bupivacaine (an anesthetic) into the knee.

  • Nerve Procedure with long acting blocksProcedure or surgery

    People assigned to receive this will have 1 milliliter (mL) of a long-acting local anesthetic (a.k.a. liposomal bupivacaine or EXPAREL) and steroid injected into the knee.

  • Nerve Procedure with nerve ablationProcedure or surgery

    People assigned to receive this will have heat applied to destroy the nerve signaling pain in the knee. Steroid will be administered after the procedure to reduce the risk of neuritis.

  • Pain Coping Skills TrainingBehavioural

    Participants will be provided with a written manual that includes login information for the pain coping skills training website. The participants will be expected to log into the system weekly, work through the modules, and participate in skills practice.

  • Best PracticesOther

    Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments.

Study groups in NCT04504812
Study groupRoleWhat they receive
Phase 1: Best Practices + DuloxetineActive comparatorParticipants will receive Duloxetine and a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments. Phase 1 ended enrollment on April 12, 2024.
Receives: Drug: Duloxetine; Other: Best Practices
Phase 1: Best Practices + Duloxetine + Pain coping skillsActive comparatorParticipants will receive Duloxetine, pain coping skills training, and a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments. Phase 1 ended enrollment on April 12, 2024.
Receives: Drug: Duloxetine; Behavioral: Pain Coping Skills Training; Other: Best Practices
Phase 2: Intra-Articular Injection (HA+)Active comparatorParticipants will receive an intra-articular injection of hyaluronic acid mixed with steroid and bupivacaine. Phase 2 ended enrollment on October 24, 2024.
Receives: Combination Product: Intra-Articular Injection
Phase 2: Nerve Procedure: Long Acting BlocksActive comparatorParticipants will receive a nerve blocking procedure, long-acting local anesthetic, and steroid injection. Phase 2 ended enrollment on October 24, 2024.
Receives: Procedure: Nerve Procedure with long acting blocks
Phase 2: Nerve Procedure: Nerve AblationActive comparatorParticipants will receive a nerve ablation procedure and steroid injection. Phase 2 ended enrollment on October 24, 2024.
Receives: Procedure: Nerve Procedure with nerve ablation
Phase 1: Best PracticesActive comparatorParticipants will receive a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments. Based on the pre-specified stopping rules described in Protocol section 13.2, the DSMB advised ceasing enrollment into Arm 1A (Best Practices). This recommendation was accepted by the sponsor and study investigators. Arm 1A (Best Practices) was closed on 11/29/2023.
Receives: Other: Best Practices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Intensity as assessed by the Modified 4-item Brief Pain Inventory (BPI) Pain Scale

    The Modified 4-item BPI Pain scale consists of 3 items from BPI Pain Intensity and 1 item from BPI Pain Interference. This is a continuous measure that will be calculated as the average of worst, average, current knee pain, and pain upon walking. Change from baseline (BL) will be used in mITT analyses, and change from treatment will be used in per protocol analyses.

    Measured: Change from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2

Secondary outcomes (8)

  1. Change in Pain Interference as assessed by the BPI

    The BPI Pain Interference domain assesses self-reported consequences of pain on relevant aspects of one's life. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. BPI Interference ranges from 0-10 with higher scores reflecting greater pain interference in activities of daily living.

    Measured: Change from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2

  2. Change in Physical Functioning as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    The KOOS evaluates function for participants with osteoarthritis of the knee that is related to injury and degeneration. The KOOS short form includes 12 items and measures pain, functional limitation and quality of life. Physical functioning questions cover everyday activities such as rising from sitting, standing getting in and out of the car and twisting/pivoting on the knee. Scores range from 0-100 with lower scores indicating worse knee symptoms.

    Measured: Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2

  3. Patient Global impression of Change (PGIC)

    The PGIC scale evaluates all aspects of participants' health and assesses if there has been an improvement or decline in clinical status. It is a 7-item scale that ranges between "a great deal worse" to "a great deal better." Higher scores reflect greater improvement in clinical status.

    Measured: 8 weeks post-randomization (mITT) and 8 weeks post-treatment (per protocol) in Phase 1; 12 weeks post-randomization (mITT) and 12 weeks post-treatment (per protocol) in Phase 2

  4. Change in Pain Intensity as assessed by the BPI

    The BPI Pain Interference domain assesses self-reported consequences of pain on relevant aspects of one's life. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. BPI Interference ranges from 0-10 with higher scores reflecting greater pain interference in activities of daily living.

    Measured: Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2

  5. Compare Morphine Milligram Equivalent (MME) doses

    Participants will be queried regarding their analgesic use over the past week (for all participants including those prescribed an opioid/other analgesic from non-study providers) to determine morphine equivalents. Adherence to prescription medication instructions will be monitored by self-report. This outcome will be applicable to: Phase 1- participants prescribed opioids prior to study initiation; Phase 2- participants prescribed opioids prior to study initiation and those who receive an opioid prescription from a study clinician during the course of the study or longer-term follow-up.

    Measured: Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2

  6. Time to receipt of additional treatment for to KOA

    Healthcare utilization will be measured as it relates to KOA on an ongoing basis throughout the study

    Measured: Up to 2 years

  7. Treatment response as a binary outcome for Phase 1 and 2 intervention arms using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) guidelines

    BPI intensity will be measured, per IMMPACT cut off guidelines and will also incorporate changes in opioid dose. A 20% decrease in pain intensity is minimally important, ⩾30% moderately important and ⩾50% substantial. Each of these brackets will be evaluated to determine responders at the pain criteria cut points.

    Despite meeting guideline criteria, anyone meeting the following will not be considered a treatment responder:

    1. Increase in new opioid use of >15 morphine milligram equivalents (MME) or;
    2. Increase of >100mg Tramadol

    Measured: Opioid use and pain are measured at all follow-up time points and will be used through Phase1: 8 weeks post-rand. and 8 weeks post-treatment; Phase 2: 12 weeks post-rand. and 8 weeks post-treatment

  8. Treatment response as a binary outcome for Phase 1 and 2 intervention arms based on OARSI-OMERACT guidelines, incorporating changes in opioid dose.

    BPI intensity, KOOS, PGIC and opioid use will be measured, and define a categorical outcome based on Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OARSI-OMERACT) guidelines (pain, function measures, and patient assessment), incorporating changes in opioid dose.

    A treatment responder will be defined as either:

    High improvement in pain or in function ≥50% and absolute change of >2 for BPI and ≥20 for KOOS,

    Or

    Improvement in at least 2 of the 3 following:

    • pain ≥20% and absolute change of >1
    • function ≥20% and absolute change ≥10
    • patient's global impression of change ≥minimal improvement

    Despite meeting guideline criteria, anyone meeting the following will not be considered a treatment responder:

    1. Increase in new opioid use of >15 morphine milligram equivalents (MME) or;
    2. Increase of >100mg Tramadol

    Measured: Opioid use and pain assessed up to 2 years. PGIC assessed at main outcome visit (8 and 12 weeks for Phase 1 and Phase 2, respectively). The treatment response categorical outcome will be analyzed separately for mITT and per- protocol analyses.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2020
  2. Study start1 Feb 2021
  3. Primary completion8 Apr 2025
  4. Study completion8 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Using a stepped care model, Phase 1 participants will be randomly assigned to minimally invasive treatments, including best practices, best practices plus duloxetine, and best practices plus duloxetine combined with a web-based pain coping skills training program. Those who note interest in additional treatment following completion of Phase 1, as well as those that are not eligible for Phase 1 treatment, will be randomly assigned to more aggressive procedures: intra-articular hyaluronic acid, steroid and local anesthetic injection, or a nerve procedure that would either include a long acting block or nerve ablation. Interim analyses will be completed for both phases, and pre-specified stopping rules will determine if all study arms will continue. Modified Intention to Treat (mITT) and per protocol analyses will be conducted.
Masking
Single blind
Who is masked
Participant
Enrolment
1,937 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04504812
Sponsor's protocol ID
IRB00238678
Other IDs
1UG3AR077360-01
Acronym
SKOAP
Status last verified
Apr 2026
First submitted
5 Aug 2020
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Upon completing data collection, specifically after the last patient's main outcome visit (excluding long-term follow-up), the HEAL Pain Management Effectiveness Research Network (ERN) Data Coordinating Center (DCC) at the University of Utah will compile the final study dataset. This dataset will undergo statistical analyses and form the basis for publishing both primary and secondary trial results. The SKOAP dataset, recognized as valuable for pain management and opioid use research communities, will be formatted for accessibility to non-ERN investigators. Additionally, a data dictionary will accompany the dataset, offering concise definitions for each included data element. Any peculiarities impacting interpretation or analysis will be outlined within the dictionary. Unreliable data elements will be removed, with documentation provided accordingly.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duloxetine, Intra-Articular Injection and Nerve Procedure with long acting blocks in people with Knee Osteoarthritis, run by Johns Hopkins University at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity as assessed by the Modified 4-item Brief Pain Inventory (BPI) Pain Scale (time frame: Change from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04504812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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