AMZ001 Gel for Knee Arthritis

(AMZ001 Trial)

Recruiting at 11 trial locations

Overseen By Amzell

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Amzell

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

Disqualifiers: Rheumatoid arthritis, Gout, Malignancy, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 6-week trial of a formulation of AMZ001 once daily versus placebo once daily.

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 AMZ001 Gel safe for use in humans?

The clinical trial for AMZ001 Gel, which contains 3.06% diclofenac, investigated its safety in people with knee osteoarthritis. Diclofenac is a common medication used for pain relief, and the trial aimed to ensure the gel is safe when applied topically. ^{1 2 3 4 5}

How is AMZ001 Gel different from other drugs for knee arthritis?

AMZ001 Gel is a new 3.06% diclofenac gel that requires fewer applications per day compared to other topical treatments, offering a faster onset and longer duration of pain relief for knee arthritis. ^{3 6 7 8 9}

Eligibility Criteria

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.

I haven't used any experimental drugs or devices in the last 3 months.

Trial Timeline

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

Treatment Details

Interventions

• AMZ001 (Nonsteroidal Anti-Inflammatory Drug)

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events Associated With Medications in the Treatment and Prevention of Rheumatoid Arthritis. [2020]

2. Canada 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. [2013]

3. United States 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. [2012]

5. United States 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. [2019]

6. England 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Arnica montana gel in osteoarthritis of the knee: an open, multicenter clinical trial. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Topical therapy for osteoarthritis: clinical and pharmacologic perspectives. [2013]

9. United States 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. [2023]