AMZ001 Gel for Knee Arthritis

(AMZ001 Trial)

Not currently recruiting at 12 trial locations

Overseen By Amzell

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amzell

Must not be taking: Opioids, Duloxetine, Pregabalin, Gabapentin

Disqualifiers: Rheumatoid arthritis, Gout, Malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a gel called AMZ001 to determine its effectiveness in reducing knee pain caused by osteoarthritis, a condition that wears down joint cartilage, leading to pain and stiffness. Participants will receive either the AMZ001 gel or a placebo (a substance with no therapeutic effect) to compare results. It suits individuals who have experienced knee osteoarthritis pain for at least 14 days in the past month. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop all current medications, but you cannot use certain medications like moderate or higher strength opioids, duloxetine, pregabalin, or gabapentin shortly before joining. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that AMZ001 gel is likely to be safe for humans?

Previous studies have shown that AMZ001 diclofenac gel is safe for treating knee arthritis. Research indicates that participants tolerated the gel well, with most experiencing no serious side effects. AMZ001 is a topical gel, which often results in fewer side effects compared to oral medications. Overall, evidence suggests that AMZ001 is generally safe for individuals with knee arthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard options for knee arthritis, which typically include oral NSAIDs and injections, AMZ001 is a topical diclofenac gel that offers a different delivery method. This gel is applied directly to the skin over the knee, potentially reducing systemic side effects commonly associated with oral medications. Researchers are excited because AMZ001 might provide targeted pain relief with fewer gastrointestinal risks, making it a promising alternative for people who can't tolerate traditional oral medications.

What evidence suggests that AMZ001 gel might be an effective treatment for knee arthritis?

Research has shown that AMZ001, a new diclofenac gel, may help relieve knee arthritis pain. Some studies found that using the gel once a day significantly reduced knee pain. The gel proved generally effective and well-tolerated. Participants in this trial will receive either the AMZ001 diclofenac gel or a placebo gel. However, using the gel twice a day did not provide clear benefits, with no significant pain relief. Overall, AMZ001 could be beneficial for knee arthritis pain when used correctly. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Except for OA, the participant is in reasonably good health as determined by the Investigator.

I have been diagnosed with knee osteoarthritis according to ACR criteria.

My knee has moderate to severe arthritis according to a recent X-ray.

Exclusion Criteria

I have severe knee pain, scoring over 45 on the WOMAC pain scale.

I have used duloxetine, pregabalin, or gabapentin in the last 4 weeks.

Observed standard deviation of the Daily osteoarthritis (OA) knee pain diary average NRS intensity score for 7 days immediately preceding baseline (Day 1) must not exceed 1.5

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AMZ001 diclofenac gel or placebo gel applied to the target knee once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AMZ001

Trial Overview 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.

How Is the Trial Designed?

Group I: AMZ001 diclofenac gel Experimental Treatment 1 Intervention

Group II: Placebo gel Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Amzell

Lead Sponsor

Trials

5

Recruited

1,100+

NBCD A/S

Industry Sponsor

Trials

11

Recruited

2,300+

Published Research Related to This Trial

In a study involving 444 subjects with knee osteoarthritis, the new 3.06% diclofenac gel (AMZ001) applied once daily showed significant pain reduction compared to placebo, indicating its efficacy as a topical analgesic.

AMZ001 was generally well tolerated, with most adverse events being mild or moderate, and no serious adverse events reported, suggesting a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial. Bihlet, AR., Byrjalsen, I., Simon, LS., et al.[2021]

In a subgroup analysis of 311 patients with knee osteoarthritis, Gel-200 showed significant improvements in pain and stiffness compared to phosphate buffered saline (PBS) at both 12 weeks (P = 0.031) and 26 weeks (P = 0.019).

The study confirms that a single injection of Gel-200 is effective in reducing symptoms of knee osteoarthritis, demonstrating clinically important improvements in WOMAC scores, which are consistent with results from other viscosupplementation trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial. Takamura, J., Seo, T., Strand, V.[2023]

In a study involving 379 patients, retreatment with Gel-200 for knee osteoarthritis showed a safety profile comparable to the first injection, with no significant differences in adverse events reported.

The effectiveness of Gel-200 remained similar between the first and second injections, indicating that patients can safely receive multiple treatments without increased risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials. Strand, V., Lim, S., Takamura, J.[2022]

In a study involving 555 patients with osteoarthritis knee pain, the ketoprofen ultradeformable vesicle gel (IDEA-033) was found to be less effective than a ketoprofen-free gel (TDT 064) in reducing pain and improving joint function over 12 weeks.

While both treatments led to decreases in pain and improvements in function, the ketoprofen-free gel resulted in a higher percentage of patients achieving significant pain relief (50.5% vs. 41.2% for IDEA-033), indicating that IDEA-033 may not be the best option for managing moderate OA knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. Rother, M., Conaghan, PG.[2013]

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

In a comprehensive analysis of 65,099 patient-years of tocilizumab (TCZ) exposure, the rates of serious adverse events (SAEs) reported in postmarketing data were found to be similar to those observed in clinical trials and external comparator populations, indicating consistent safety profiles across different settings.

The study highlights that the rates of specific SAEs, such as serious hepatic events and myocardial infarctions, were comparable to those seen in anti-tumor necrosis factor (aTNF) treated rheumatoid arthritis patients, suggesting that TCZ's safety profile is in line with existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tocilizumab in rheumatoid arthritis: a case study of safety evaluations of a large postmarketing data set from multiple data sources. Curtis, JR., Perez-Gutthann, S., Suissa, S., et al.[2019]

Topical NSAIDs, like diclofenac sodium 1% gel, provide effective pain relief for osteoarthritis (OA) with less risk of serious side effects compared to oral NSAIDs, making them a preferred option for patients with mild-to-moderate OA.

Clinical trials indicate that diclofenac sodium 1% gel offers significant analgesia with a low incidence of systemic adverse events, supporting its use as a safe and effective treatment for OA in the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical therapy for osteoarthritis: clinical and pharmacologic perspectives. Altman, R., Barkin, RL.[2013]

Current treatments for rheumatoid arthritis (RA) can lead to a significant burden of adverse events (AEs), with serious AEs being low in individuals at risk for RA, but nonserious AEs are often not consistently reported.

For effective prevention of RA in high-risk patients, it is crucial to quantify the benefits and harms of treatments accurately and consider patient preferences, especially regarding serious AEs like infections and malignancies that may not reverse after stopping the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events Associated With Medications in the Treatment and Prevention of Rheumatoid Arthritis. Costello, R., David, T., Jani, M.[2020]

In a trial involving 79 participants with mild to moderate knee osteoarthritis, applying Arnica montana gel twice daily resulted in significant reductions in pain, stiffness, and overall function after 3 and 6 weeks, as measured by the WOMAC index.

The gel was found to be safe and well-tolerated, with only a 7.6% rate of local adverse events and a high satisfaction rate, as 87% of patients rated its tolerability positively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arnica montana gel in osteoarthritis of the knee: an open, multicenter clinical trial. Knuesel, O., Weber, M., Suter, A.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33059293/

A novel diclofenac gel (AMZ001) applied once or twice ... Conclusions: Treatment with AMZ001 BID for 4 weeks improved WOMAC pain sub-scores; however, only QD application conferred nominally statistically significant ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06693648

NCT06693648 | A Study to Evaluate Efficacy and Safety of ... This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 6-week trial of a formulation of AMZ001 once daily versus placebo once ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S004901722030250X

A novel diclofenac gel (AMZ001) applied once or twice ... Conclusions. AMZ001 applied BID for 4-weeks for the treatment of knee OA symptoms did not statistically significantly improve WOMAC pain sub-score compared with ...

4. ard.bmj.com ard.bmj.com/content/79/suppl_1/1735.1.full

A NOVEL DICLOFENAC SODIUM 3.06% GEL Conclusion: AMZ001, a novel topical diclofenac formulation, either once or twice daily was efficacious in the treatment of knee OA pain with a good tolerability ...

5. trial.medpath.com trial.medpath.com/clinical-trial/18a5ceec9ddb1a9d/euctr2018-001934-16-dk-diclofenac-gel-amz001-knee-osteoarthritis

A study of the safety and efficacy of Diclofenac Gel AMZ001 ... A study of the safety and efficacy of Diclofenac Gel AMZ001 3.06 % for the treatment of knee osteoarthritis symptoms. ... Outcome data and publication updates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11892197/

Efficacy and safety of different topical diclofenac ... All formulations were well-tolerated, with no significant increase in adverse events.