X0002 Spray for Osteoarthritis

Recruiting at 42 trial locations

Overseen By Mark Hermann, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Techfields Pharma Co. Ltd

Must not be taking: Opiates, Corticosteroids, Antidepressants, others

Disqualifiers: Knee surgery, Chronic inflammatory disease, 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: 2

399 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new spray called X0002 to relieve knee pain in people with osteoarthritis. The spray is applied to the skin and works by reducing pain directly in the knee area. The study will compare different doses of the spray to see which works best and check for any side effects.

Will I have to stop taking my current medications?

Yes, you will need to stop taking NSAIDs (non-steroidal anti-inflammatory drugs) and other pain relievers like aspirin and acetaminophen during the study, except for a small dose of aspirin for heart health. You can use acetaminophen as a backup for pain, but not right before certain study visits.

Is X0002 Spray safe for humans?

The treatment with D-002 (beeswax alcohols), which may be related to X0002 Spray, was well tolerated in clinical studies for osteoarthritis, showing a good safety profile. ^{1 2 3 4 5}

How does the X0002 Spray treatment for osteoarthritis differ from other treatments?

The X0002 Spray treatment for osteoarthritis is unique because it is a topical application, which may offer a more convenient and potentially safer alternative to oral medications that can have adverse effects. While the specific components of X0002 Spray are not detailed, similar treatments like D-002 (beeswax alcohols) and D-003 (sugarcane wax acids) have shown effectiveness in reducing osteoarthritis symptoms with fewer side effects compared to traditional nonsteroidal anti-inflammatory drugs. ^{1 2 6 7 8}

What data supports the effectiveness of the X0002 Spray treatment for osteoarthritis?

Research on intra-articular therapies, like corticosteroids and hyaluronate, shows benefits such as increased effectiveness and fewer side effects when delivered directly into joints. Additionally, glucosamine sulphate has been shown to help with osteoarthritis symptoms and may slow disease progression, suggesting that similar treatments could be effective. ^{9 10 11 12 13}

Who Is on the Research Team?

Chongxi Yu, PhD

Principal Investigator

Techfields Inc

Are You a Good Fit for This Trial?

This trial is for adults aged 35-85 with knee pain from osteoarthritis (OA) who've had symptoms for at least 6 months and meet specific clinical criteria. They must not be pregnant, planning pregnancy, or breastfeeding, and agree to use birth control if applicable. Participants should have a BMI between 18.5 and 45 kg/m2 and can't use certain medications or treatments that might affect the study.

Inclusion Criteria

You have experienced knee pain while standing, walking, or moving for at least 2 weeks before the screening.

You have experienced symptoms of knee OA for at least six months.

age of ≥50 years

Exclusion Criteria

Has uncontrolled hypertension defined as systolic blood pressure >170 mmHg and diastolic blood pressure >90 mmHg at the Screening or Baseline Visit (may be repeated after 5 minutes rest to verify).

Is receiving systemic chemotherapy, has an active malignancy, lymphoproliferative disorder, or blood dyscrasia of any type, or has been diagnosed with cancer within 5 years before Screening. Subjects with completely excised squamous or basal cell carcinoma of the skin will be allowed.

Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, or renal disease, or any other condition that, in the Investigator's opinion, could confound the study results, compromise the subject's welfare, interfere with the ability to communicate with the study staff, or otherwise contraindicate study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Double-blind Treatment

Participants receive either a low-dose or high-dose of X0002 or placebo for 22 weeks

22 weeks

Regular visits for assessments

Open-label Treatment

Participants receive X0002 spray for 30 weeks

30 weeks

Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• X0002 Spray

Trial Overview The trial is testing X0002 Spray's effectiveness in relieving knee pain caused by OA over a period of up to 52 weeks. It involves an initial double-blind phase where neither participants nor researchers know who receives the spray or placebo, followed by an open-label phase where everyone knows they're getting the spray.

How Is the Trial Designed?

Group I: Group A Experimental Treatment 1 Intervention

High dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)

Group II: Group B Placebo Group 1 Intervention

Low dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)

Who Is Running the Clinical Trial?

Techfields Pharma Co. Ltd

Lead Sponsor

Trials

2

Recruited

400+

Published Research Related to This Trial

The adoption of the OMERACT-OARSI core outcome set (COS) in hip and knee osteoarthritis trials decreased significantly from 61% in 1997-2001 to 38% in 2012-2016, highlighting a concerning trend in trial reporting.

While pain and physical function were the most commonly included domains in these trials, the patient's global assessment was notably underrepresented, being included in only 48% of studies, indicating a need for improved adherence to COS guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017. Smith, TO., Mansfield, M., Hawker, GA., et al.[2023]

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]

Citations

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

Progress in intra-articular therapy. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Long-term effects of glucosamine sulphate on osteoarthritis progression: a randomised, placebo-controlled clinical trial. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of corticosteroid in the treatment of hand osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of osteoarthritis crystalline glucosamine sulphate/a review of the clinical effcacy]. [2013]

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

Effects of a Combined Therapy With D-002 (Beeswax Alcohols) Plus D-003 (Sugarcane Wax Acids) on Osteoarthritis Symptoms. [2018]

7. Argentina pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and tolerability of chondroitin plus glucosamine and D-002 (beeswax alcohols) in subjects with osteoarthritis symptoms. [2017]

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

A randomised, placebo controlled, comparative trial of the gastrointestinal safety and efficacy of AZD3582 versus naproxen in osteoarthritis. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Systematic review of the nutritional supplements dimethyl sulfoxide (DMSO) and methylsulfonylmethane (MSM) in the treatment of osteoarthritis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Recent developments in the treatment of osteoarthritis with NSAIDs. [2019]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Evaluation of the effect of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms. [2021]

12. 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]

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

Notoginseng Radix and Rehmanniae Radix Preparata Extract Combination (YH23537) Reduces Pain and Cartilage Degeneration in Rats with Monosodium Iodoacetate-Induced Osteoarthritis. [2018]