G001 Gel for Osteoarthritis

No longer recruiting at 16 trial locations

Overseen By Heather M Karabaich

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BUZZZ Pharmaceuticals Limited

Must not be taking: Opioids, Antidepressants, Antipsychotics, others

Disqualifiers: Severe OA, Other arthritis, Neurological, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical gel, G001, for individuals with osteoarthritis (OA) of the knee to determine if it can reduce pain and improve safety compared to a placebo gel. Participants will discontinue their usual pain medications to evaluate the gel's effectiveness on its own. This trial may suit those who have experienced mild to moderate knee OA for at least six months and currently endure significant daily knee pain. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important advancements in OA treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking NSAIDs and acetaminophen before starting the trial to allow for a washout period (time without taking certain medications) and to assess your pain levels without them.

Is there any evidence suggesting that G001 Topical Gel is likely to be safe for humans?

Research has shown that treatments like G001 gel applied to the skin are generally safe. However, caution is advised. Some individuals have reported skin reactions, such as redness or itching, when using topical gels. Serious reactions are rare but possible, so monitoring for any changes is crucial. In this study, the gel is applied to the knee, which may reduce the risk of side effects compared to oral medication. Report any unusual symptoms to the study team immediately. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for osteoarthritis of the knee, which often include oral medications like NSAIDs or injectable options such as corticosteroids and hyaluronic acid, G001 Topical Gel offers a unique approach. This treatment is applied directly to the skin over the affected knee, potentially minimizing systemic side effects associated with oral medications. Researchers are excited about G001 because it promises targeted relief while maintaining a convenient and non-invasive application method. Additionally, the topical nature of G001 may allow for more frequent dosing, which could enhance its effectiveness in managing pain and inflammation associated with osteoarthritis.

What evidence suggests that G001 Topical Gel might be an effective treatment for OA of the knee?

Studies have shown that topical diclofenac products, such as G001 Topical Gel, significantly aid individuals with knee osteoarthritis by reducing pain and enhancing movement compared to a placebo. Earlier research found that participants using diclofenac gel experienced less knee pain and improved mobility. These improvements were measured using the WOMAC pain index, a standard method for assessing pain levels and movement ease. Additionally, diclofenac gels are generally safe and well-tolerated over several weeks of use. These findings suggest that G001 Topical Gel, which participants in this trial may receive, could effectively reduce knee pain and assist with daily activities for those with osteoarthritis. ^{6 7 8 9 10}

Who Is on the Research Team?

Deirdre O'Keeffe, PhD

Principal Investigator

Buzzz Pharma

Are You a Good Fit for This Trial?

Inclusion Criteria

Documented diagnosis of OA of the knee, meeting American College of Rheumatology (ACR) criteria for classification of idiopathic (primary) OA for at least 6 months prior to Screening

Radiologic evidence of OA of the knee of grade 2 (mild) or grade 3 (moderate) according to Kellgren and Lawrence Radiographic Grading

Worst daily pain (within 24 hours prior to Screening and Baseline) in the index knee between 4 and 8 on the 11-point pain NRS

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive G001 or Vehicle topical gel applied to the index knee four times a day

4 weeks

3 visits (in-person) at Weeks 2, 4, and 5

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person) for end-of-study evaluations

What Are the Treatments Tested in This Trial?

Interventions

• G001 Topical Gel
• Vehicle

How Is the Trial Designed?

Group I: G001 Topical Gel Experimental Treatment 1 Intervention

G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.

Group II: Vehicle Topical Gel Placebo Group 1 Intervention

Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.

Who Is Running the Clinical Trial?

BUZZZ Pharmaceuticals Limited

Lead Sponsor

Trials

1

Recruited

210+

Veristat, Inc.

Collaborator

Trials

12

Recruited

2,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21174485/

Safety and efficacy of topical diclofenac sodium gel for ... Conclusions: DSG was effective and generally well tolerated in adults regardless of age. These data support the topical application of DSG for relief of OA knee ...

2. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08465-7

Efficacy and safety of different topical diclofenac formulations ... Topical diclofenac formulations (gel, solution, patch) significantly improve pain and function in knee osteoarthritis compared to placebo.

3. haleonhealthpartner.com haleonhealthpartner.com/en-us/pain-relief/brands/voltaren/science/knee-efficacy-clinical-study-data/

Clinical Study Data: Knee Efficacy Results: Patients treated with DSG 1% exhibited significant improvement compared to vehicle in: Mean WOMAC pain index at Week 12; Mean WOMAC physical function at ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085454/

Evaluating the Real-World Use of Topical Diclofenac Sodium ... In clinical studies, DSG1% was shown to be safe and well-tolerated in patients with hand or knee OA for up to 8 weeks' and 12 weeks' duration, ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-of-diclofenac-gel-amz001-for-treating-knee-osteoarthritis-pain-in-adults/

Study on the Effectiveness of Diclofenac Gel AMZ001 for ... The purpose of the study is to evaluate how effective and safe the diclofenac gel AMZ001 is in reducing knee pain and symptoms associated with ...

6. safcodental.com safcodental.com/media/catalog/SDS/$3350006.pdf?srsltid=AfmBOoon6TB4RyMDWcHhZK5vuYi0Eui_4tY98Tq3FwnlfSfG6eUVAJEF

SAFETY DATA SHEET Precautionary statements. Prevention. : Wear protective gloves. Wear eye or face protection. Wash hands thoroughly after handling. Response.

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=8aeb1434-6a8a-4ac1-9c9a-b488bd483119&type=pdf

GELATO TOPICAL ANESTHETIC Other Ingredients. Ingredient Kind. Ingredient Name. Quantity. May contain. FD&C YELLOW NO. 5 (UNII: I753WB2F1M). May contain. FD&C YELLOW NO.

8. germiphene.com germiphene.com/wp-content/uploads/2022/02/ZAP-EN-DIN-01930699.pdf

ZAP - Safety Data Sheet Hazard statements (GHS-CA). : H317 - May cause an allergic skin reaction. H319 - Causes serious eye irritation. H370 - Causes damage to organs.

9. fda.report fda.report/DailyMed/923636fb-8f9a-480b-e053-2995a90a618e

SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount ...

10. dhpsupply.com dhpsupply.com/msds/120-20118.pdf

SAFETY DATA SHEETS This SDS ... Primary Routes of Exposure. Ingestion: May cause gastrointestinal tract irritation with nausea, vomiting, diarrhea. May affect.