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X0002 Spray for Osteoarthritis
Phase 3
Waitlist Available
Research Sponsored by Techfields Pharma Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, 4, 8, 12 and 22 of treatment
Awards & highlights
Pivotal Trial
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with topical treatments may include skin irritation at the application site, allergic reactions, itching, redness, and possible systemic effects if absorbed through the skin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2, 4, 8, 12 and 22 of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 4, 8, 12 and 22 of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
WOMAC pain subscale score in the target knee at Week 12 compared to Baseline
Secondary study objectives
Average eDiary daily (NRS) score in the target knee
Subject's Global Assessment of Disease Status at Week 12.
WOMAC (NRS) pain subscale in the target knee at Week 2, 4, 8, and 22
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group AExperimental Treatment1 Intervention
High dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)
Group II: Group BPlacebo Group1 Intervention
Low dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
X0002
2021
Completed Phase 3
~650
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for osteoarthritis (OA) primarily target pain relief and inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the production of inflammatory mediators.
Glucocorticoids, administered orally or via intraarticular injections, suppress inflammation by inhibiting multiple inflammatory pathways. These treatments are crucial for OA patients as they provide symptomatic relief, improving mobility and quality of life, although they do not alter the disease's structural progression.
The X0002 Spray, being studied for knee OA, likely aims to offer similar pain relief through a topical application, potentially reducing systemic side effects associated with oral medications.
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Who is running the clinical trial?
Techfields Pharma Co. LtdLead Sponsor
1 Previous Clinical Trials
Mark UknisStudy ChairTechfields Inc
Mark E Uknis, MD, FACSStudy ChairTechfields Inc
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Eligibility Criteria:
This trial includes the following eligibility 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.You are female and either not of childbearing potential or willing to practice at least 1 of the following medically acceptable methods of birth control.You have arthritis in your knee or other joints in your leg that could affect how we measure pain and movement in your knee.You have received stem cell therapy through injection or intravenous (IV) in the 6 months before being screened for this study.You have knee pain that has been bothering you for at least 6 months.You have a long-term inflammatory condition like arthritis or inflammatory bowel disease, or a chronic pain condition like fibromyalgia. You may also have other conditions that can affect the joint being assessed for pain and function.The doctor thinks you have a problem with drinking too much alcohol or using drugs.You have had a strong reaction, intolerance, or allergy to ibuprofen, aspirin, acetaminophen, or other similar medications in the past.You have knee pain and at least three of the following: you are over 50 years old, your knee stiffness lasts less than 30 minutes, your knee makes a crunching sound when you move it, your knee is tender to touch, your knee is enlarged, and there is no warmth in the area.You feel pain when pressure is applied to your bones.You have severe depression or other mental health conditions that are not under control. If you have controlled depression or another mental health condition and take medication, you must be on a stable dose of medication (except for certain types) for at least 12 weeks before the study.You have had to take strong medications for asthma in the past year. However, if you only use asthma inhalers, you can still participate.You are able to read and provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and applicable regulations.Subject must have a body mass index (BMI) between 18.5 and 40 kg/m2, inclusive.You have stiffness that lasts less than 30 minutes.You experience a cracking or popping sensation when you move your knee.You have been experiencing knee pain and other symptoms of osteoarthritis for at least 6 months.You have experienced knee pain while standing, walking, or moving for at least two weeks before the screening.You have knee pain that is rated between 4 and 9 on a scale of 0 to 10, on most days for at least a week before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Knee osteoarthritis Patient Testimony for trial: Trial Name: NCT03081806 — Phase 3
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