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Nonsteroidal Anti-Inflammatory Drug
AMZ001 Gel for Knee Arthritis (AMZ001 Trial)
Phase 3
Waitlist Available
Research Sponsored by Amzell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Femorotibial osteoarthritis (OA) of the knee, according to the American College of Rheumatology (ACR) clinical and radiographic criteria (Altman et al. 1986)
Radiological OA grade 2, or 3 of the target knee, using the Kellgren-Lawrence method (Kellgren & Lawrence 1957) as graded by central, independent reading of X-ray obtained during screening, or on a recent (within 6 months) X-ray image which fulfils the specifications for central reading.
Must not have
Presence of severe pain in either knee, defined as > 45 out of 50 in response to the WOMAC pain sub-score (5 questions), at the time of screening and baseline, regardless of the eligibility of the contralateral knee.
High dose (equivalent to > 10 mg of prednisone/day) systemic corticosteroid treatment of more than 14 days during the past 6 months prior to screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 8
Awards & highlights
Pivotal Trial
Summary
This trial will test a new medication called AMZ001 once a day for 6 weeks, compared to a placebo pill, in multiple centers.
Who is the study for?
This clinical trial is for individuals with knee osteoarthritis who are seeking treatment for their symptoms. Participants should be adults who meet the study's specific health requirements, but details on these criteria have not been provided.
What is being tested?
The trial is testing AMZ001 Diclofenac gel, a medication aimed at treating knee osteoarthritis symptoms, against a placebo gel. The study randomly assigns participants to either the test drug or placebo and compares results over six weeks.
What are the potential side effects?
While specific side effects of AMZ001 are not listed here, typical side effects of topical diclofenac gels include skin irritation at the application site, itching, dryness, redness, scaling or numbness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with knee osteoarthritis according to ACR criteria.
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My knee has moderate to severe arthritis according to a recent X-ray.
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My usual knee pain without medication is 4 or more on a scale of 10.
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I have had knee pain for most of the last month due to arthritis.
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My target knee hurts more than my other knee.
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My knee pain score is between 20 and 45 out of 50.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe knee pain, scoring over 45 on the WOMAC pain scale.
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I haven't taken high doses of steroids for more than 2 weeks in the last 6 months.
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I have more pain in my hip(s) than in my knee, or I suffer from significant pain that spreads from my back.
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My kidney function is severely reduced.
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I haven't used any skin medication on the area for the last 15 days.
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My knee osteoarthritis is due to previous injury or surgery.
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I can apply gel to my knee without any physical problems.
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I haven't had steroid or hyaluronic acid injections in my knee in the last 6 months or in any joint in the last 30 days.
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I am scheduled for knee surgery within the next year.
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I haven't had major knee surgery or fluid removal from the knee in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in the WOMAC pain sub-score in the target knee at week 2.
Secondary study objectives
Change from baseline in daily pain at Day 8 using an 11-point Numeric Rating Scale (NRS)
Change from baseline in the WOMAC pain sub-score at week 1, in the target knee
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AMZ001 diclofenac gelExperimental Treatment1 Intervention
Group II: Placebo gelPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
AmzellLead Sponsor
4 Previous Clinical Trials
552 Total Patients Enrolled
1 Trials studying Osteoarthritis
444 Patients Enrolled for Osteoarthritis
NBCD A/SIndustry Sponsor
10 Previous Clinical Trials
1,791 Total Patients Enrolled
7 Trials studying Osteoarthritis
1,299 Patients Enrolled for Osteoarthritis