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Other

Blinded Study Medication for Osteoarthritis

Phase 2
Waitlist Available
Led By Claudia M Campbell, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of knee osteoarthritis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hour study session
Awards & highlights

Study Summary

This trial is testing the effectiveness of combining two drugs that are FDA approved, but have not yet been approved for use together, in reducing pain.

Who is the study for?
This trial is for adults with knee osteoarthritis who are not using opioids, have no allergies to the study medications, and do not use certain other pain or psychiatric medications. Participants must test negative for illicit drugs, be medically cleared to take the study meds, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing a combination of FDA-approved medications that haven't been approved together yet. The goal is to see if this new mix can better reduce knee pain in osteoarthritis patients compared to what's currently available.See study design
What are the potential side effects?
Since specific side effects aren't listed here, generally speaking, combining different medications could increase the risk of drowsiness, stomach upset, dizziness or more serious reactions depending on the drugs' profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with knee osteoarthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hour study session
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hour study session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Largest change from baseline on pain rating

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 4Experimental Treatment1 Intervention
Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
Group II: Arm 3Experimental Treatment1 Intervention
Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
Group III: Arm 2Experimental Treatment1 Intervention
Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
Group IV: Arm 1Experimental Treatment1 Intervention
Blinded study medication. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinded study medication
2017
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,542 Total Patients Enrolled
1 Trials studying Osteoarthritis
200 Patients Enrolled for Osteoarthritis
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,488 Total Patients Enrolled
20 Trials studying Osteoarthritis
4,777 Patients Enrolled for Osteoarthritis
Johns Hopkins UniversityLead Sponsor
2,258 Previous Clinical Trials
14,820,442 Total Patients Enrolled
9 Trials studying Osteoarthritis
2,543 Patients Enrolled for Osteoarthritis

Media Library

Blinded study medication (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03098563 — Phase 2
Osteoarthritis Research Study Groups: Arm 3, Arm 2, Arm 4, Arm 1
Osteoarthritis Clinical Trial 2023: Blinded study medication Highlights & Side Effects. Trial Name: NCT03098563 — Phase 2
Blinded study medication (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03098563 — Phase 2
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03098563 — Phase 2

Frequently Asked Questions

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

How many people are being chosen for this trial?

"The information on clinicaltrials.gov does show that the study is still recruiting patients. The first posting was on 11/1/2017, with the most recent update being on 11/7/2022. They are looking for 80 participants at 1 site."

Answered by AI

Is the medication for this study FDA approved?

"Since this is a Phase 2 trial, and thus there is only anecdotal evidence for the safety of the study medication, our team has given it a score of 2."

Answered by AI

Are people with the required qualifications able to join this clinical trial at this time?

"The information available on clinicaltrials.gov indicates that this trial is looking for participants. The first posting was on November 1st, 2017 and the most recent edit was on November 7th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Johns Hopkins
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I had a knee revision at Union Memorial in March 2021. Excessive meds were a contributing factor to my fall which damaged my quads in the same leg (left). Had a quad repair surgery in October 2021 utilizing mesh with Ron Delanois at Lifebridge Health. I have been diagnosed with osteoarthritis in my right knee and would like to avoid any surgery on that side. Have done quite a bit of reading regarding alternate therapies and am interested in trying something that will help alleviate the pain on that knee.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis
2017. "Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03098563.
~12 spots leftby Apr 2025
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