Phase 1:Best Practices + Duloxetine + Pain coping skills for Osteoarthritis

Q: Can I enroll in this clinical trial?

<p>Osteoarthritis patients that <a href="https://www.withpower.com/clinical-trials/als">als</a>o have <a href="https://www.withpower.com/clinical-trials/knee-pain">knee pain</a> and are between 18 and 90 years old are good candidates for this clinical trial, of which there are 2700 total slots.</p>

University of Utah, Salt Lake City, UT

Duloxetine +5 morePhase 3RecruitingLed by Steven Cohen, MDResearch Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upat 8 weeks post-treatment for phase 1; at 12 weeks post-treatment for phase 2

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Study Summary

This trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA. The results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.

Eligible Conditions

Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 8 weeks post-treatment for phase 1; at 12 weeks post-treatment for phase 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 8 weeks post-treatment for phase 1; at 12 weeks post-treatment for phase 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 weeks post-treatment for phase 1; at 12 weeks post-treatment for phase 2 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 Pain Intensity as assessed by the Modified 4-item BPI Pain Scale

Secondary outcome measures

Change in Pain Interference as assessed by the BPI

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

Patient Global impression of Change (PGIC)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Active Control

Group I: Phase 1:Best Practices + Duloxetine + Pain coping skillsActive Control3 Interventions

Participants will receive Duloxetine and pain coping skills training in addition to an intervention from the best practices.

Group II: Phase 1: Best Practices + DuloxetineActive Control2 Interventions

Participants will receive Duloxetine in addition to an intervention from the best practices.

Group III: Phase 1: Best PracticesActive Control1 Intervention

Participants will receive an intervention from the best practices.

Group IV: Phase 2: Intra-Articular Injection (HA+)Active Control1 Intervention

Participants will receive an intra-articular injection of hyaluronic acid mixed with steroid and bupivacaine.

Group V: Phase 2: Nerve Procedure: Long Acting BlocksActive Control1 Intervention

Participants will receive a nerve blocking procedure, long-acting local anesthetic, and steroid injection.

Group VI: Phase 2: Nerve Procedure: Nerve AblationActive Control1 Intervention

Participants will receive a nerve ablation procedure and steroid injection.

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,149 Previous Clinical Trials

14,806,656 Total Patients Enrolled

9 Trials studying Osteoarthritis

823 Patients Enrolled for Osteoarthritis

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

464 Previous Clinical Trials

1,082,188 Total Patients Enrolled

49 Trials studying Osteoarthritis

45,132 Patients Enrolled for Osteoarthritis

Steven Cohen, MDPrincipal Investigator

Johns Hopkins University

11 Previous Clinical Trials

1,164 Total Patients Enrolled

Media Library

Best Practices Clinical Trial Eligibility Overview. Trial Name: NCT04504812 — Phase 3

Osteoarthritis Research Study Groups: Phase 1:Best Practices + Duloxetine + Pain coping skills, Phase 1: Best Practices + Duloxetine, Phase 1: Best Practices, Phase 2: Intra-Articular Injection (HA+), Phase 2: Nerve Procedure: Long Acting Blocks, Phase 2: Nerve Procedure: Nerve Ablation

Osteoarthritis Clinical Trial 2023: Best Practices Highlights & Side Effects. Trial Name: NCT04504812 — Phase 3

Best Practices 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504812 — Phase 3

Osteoarthritis Patient Testimony for trial: Trial Name: NCT04504812 — Phase 3

Frequently Asked Questions

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

How many patients will be treated with this new medication?

"To move this study forward, we need 2700 participants that fit the bill in terms of our specified inclusion criteria. Patients can come from various locations, such as Brigham and Women's Hospital in Boston, Massachusetts and Johns Hopkins in Baltimore, Maryland."

Answered by AI

Can I enroll in this clinical trial?

"Osteoarthritis patients that also have knee pain and are between 18 and 90 years old are good candidates for this clinical trial, of which there are 2700 total slots."

Answered by AI

Have there been any other research projects that explore similar methods for managing pain?

"Right now, there are 4 Phase 3 and 26 Phase 1 clinical trials ongoing for the combination of duloxetine and pain coping skills. Most of the Phase 1 trials are taking place in Redwood City, California, but there are a total of 786 research sites for this phase of the study."

Answered by AI

In how many different cities is this trial being run?

"patients can enroll in this study at Brigham and Women's Hospital in Boston, Johns Hopkins in Baltimore, the University of California San Diego in San Diego, or one of the 17 other sites."

Answered by AI

Are there any empty slots in this research project that patients could fill?

"That is accurate. The clinical trial is currently recruiting patients, with the first posting on February 1st, 2021 and the most recent update on August 29th, 2022. There are 1700 patients needed for the trial, which will be conducted at 17 different locations."

Answered by AI

Does the age limit for this research extend to people over 65 years old?

"The age limit for this particular trial is 18-90. However, there are other studies with different age brackets. For those under 18, there are 39 studies, and for patients over the age of 65, there are 701 studies."

Answered by AI

What psychological and physical ailments does Phase 1:Best Practices + Duloxetine + Pain coping skills typically address?

"Duloxetine in combination with best practices and pain coping skills is most often used to treat diabetic peripheral neuropathy. However, this phase 1 treatment can also be used to ameliorate other conditions such as knee pain, major depressive disorder, and disorders of the musculoskeletal system."

Answered by AI

Has the FDA cleared Phase 1:Best Practices + Duloxetine + Pain coping skills for use?

"Given that this is a Phase 3 trial with evidence of efficacy and multiple rounds of data supporting safety, our team rates the safety of Phase 1:Best Practices + Duloxetine + Pain coping skills as a 3."

Answered by AI

Who else is applying?

What state do they live in?

Oregon

Washington

Other

Maryland

How old are they?

18 - 65

65+

What site did they apply to?

University of Minnesota

Johns Hopkins

University of Washington

Other

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I can no longer take Antiinflammatory meds for my arthritis due to Stage 3 CKD and am I a lot of extra pain.

Patient

Already on duloxitine. Still have knee pain. Have had corticosteroid injection. Almost had a knee replacement but didn't.

Patient

Had 3 surgeries on my left knee (revision of prior TKR and two surgeries to repair torn quads). I want to avoid any surgery on the right knee.

Patient

I have osteoarthritis in the outside of my right knee due to 2 acl surgeries and the lack of a meniscus. I am a relatively fit 41 year old who remains active.

Patient

The chronic low level of pain that I live with undermines my physical,social,and mental health, interfers with my home and work life that I am dissatisfied with.

Patient