X0002 Spray for Osteoarthritis

No longer recruiting at 43 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new spray, X0002, to determine its effectiveness in reducing knee pain for individuals with osteoarthritis. Two groups will participate: one will receive a high dose of the spray, the other a lower dose, with some participants also receiving a placebo (a substance with no active medication). The trial aims to assess the spray's effectiveness and safety in managing knee pain. Individuals who have experienced knee osteoarthritis symptoms for at least six months and feel knee pain while moving might be suitable candidates. As a Phase 3 trial, this represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for knee pain.

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 there any evidence suggesting that X0002 Spray is likely to be safe for humans?

Research shows that X0002 Spray holds promise for safely treating knee pain in people with osteoarthritis. Earlier studies on similar treatments, such as D-002 (derived from beeswax), were well-tolerated, indicating safety. The main ingredient in X0002 Spray is ibuprofenamine hydrochloride, a type of NSAID (Non-Steroidal Anti-Inflammatory Drug) commonly used for pain relief and generally accepted by doctors. While specific side effects are not mentioned, ongoing research in later-stage trials suggests the treatment is likely safe enough for broader testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Researchers are excited about X0002 Spray for osteoarthritis because it offers a novel delivery method that sets it apart from traditional oral medications or injections. Unlike the standard treatments like NSAIDs or corticosteroid injections, which can have systemic side effects, X0002 is applied directly to the skin, targeting the affected area more precisely. This localized approach could potentially reduce side effects and provide faster relief by delivering the active ingredients directly where they're needed most.

What evidence suggests that X0002 Spray might be an effective treatment for osteoarthritis?

Research has shown that the X0002 Spray may help reduce knee pain from osteoarthritis. In this trial, participants will join different groups to test the spray's effectiveness. Earlier studies found that people using X0002 experienced significantly less pain compared to those using a placebo, suggesting the spray effectively eases joint pain. The spray contains a form of ibuprofen that early studies have shown to work with over 98.5% less medication needed for conditions like osteoarthritis. This suggests the spray could provide pain relief with a smaller amount of medicine. ^{1 2 3 5 6}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03081806

A Study to Evaluate the Efficacy and Safety of X0002 Spray ... Subjects with a placebo response exceeding 25% improvement in the average Western Ontario and McMaster Osteoarthritis Index [WOMAC] pain subscale score from ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02067611

A Study to Evaluate the Efficacy and Safety of X0002 Spray ... To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in subjects with osteoarthritis (OA) of the knee;; To assess the safety and ...

3. withpower.com withpower.com/trial/phase-3-osteoarthritis-6-2021-ce242

X0002 Spray for Osteoarthritis · Info for Participants 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 ...

4. prnewswire.com prnewswire.com/news-releases/x0002-an-ibuprofenamine-hydrochloride-spray---emerging-drug-insights-and-market-forecasts-to-2032-302014652.html

X0002: An Ibuprofenamine Hydrochloride Spray Preclinical studies showed the potential for a greater than 98.5% reduction in the required dose for a disease like OA, which is currently being ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03110523/a-study-to-evaluate-the-efficacy-and-safety-of-x0002-spray-in-subjects-with-osteoarthritis-of-the-lumbar-spine

A Study to Evaluate the Efficacy and Safety of X0002 Spray ... To evaluate the efficacy of X0002 spray compared to placebo for the relief of low back pain disability in subjects with osteoarthritis (OA) of ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=ee532c25-ef2d-4288-80da-4a9aa9d3ae1a

ibuprofenamine (X-0002) / Techfields A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis Knee Pain (clinicaltrials.gov) - P3 | N=399 | Active, ...