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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
Must have a history of clinically symptomatic OA of the knee for ≥6 months.
Bony Tenderness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, 4, 8, 12 and 22 of treatment
Awards & highlights

Study Summary

This trial is testing a new spray to see if it is effective in relieving pain for people with osteoarthritis of the knee. The trial will last 22 weeks and will have a 30-week extension.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have experienced symptoms of knee OA for at least six months.
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You feel pain when pressure is applied to your bones.
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You have stiffness that lasts less than 30 minutes.
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You experience a cracking or popping sensation when you move your knee.
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You have been experiencing knee pain and other symptoms of osteoarthritis for at least 6 months.
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You have experienced knee pain while standing, walking, or moving for at least two weeks before the screening.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 4, 8, 12 and 22 of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 4, 8, 12 and 22 of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
WOMAC pain subscale score in the target knee at Week 12 compared to Baseline
Secondary outcome measures
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 more

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

Find a Location

Who is running the clinical trial?

Techfields Pharma Co. LtdLead Sponsor
1 Previous Clinical Trials
1 Trials studying Osteoarthritis
Chongxi Yu, PhDStudy ChairTechfields Inc
Mark UknisStudy ChairTechfields Inc

Media Library

X0002 Spray (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03081806 — Phase 3
Osteoarthritis Research Study Groups: Group A, Group B
Osteoarthritis Clinical Trial 2023: X0002 Spray Highlights & Side Effects. Trial Name: NCT03081806 — Phase 3
X0002 Spray (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03081806 — Phase 3
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03081806 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are included in this experiment?

"That is correct. The clinical trial in question, which was first advertised on September 24th 2021, according to the website clinicaltrials.gov, is still recruiting patients. They are looking for a total of 408 participants at 35 different medical sites."

Answered by AI

Which patients are qualified to take part in this experiment?

"This study is in search of 408 individuals that are experiencing pain related to osteoarthritis of the knee, and meet the following age, gender, reproductive health, body mass index, and symptom criteria: 35-85 years old, male or female (that are not pregnant or breastfeeding), a BMI between 18.5-40 kg/m2 , stiffness lasting less than 30 minutes, crepitus on knee motion, and bony tenderness."

Answered by AI

Would this particular clinical trial be appropriate for elderly patients?

"According to the guidelines set out by the researchers, individuals aged 35 to 85 are eligible for this trial. For reference, there are 39 other similar studies that test subjects who are under 18 years old and 688 comparable trials with a subject pool of people over 65."

Answered by AI

Are there any unfilled appointments for this research project?

"That is correct, the online clinicaltrials.gov registry currently lists this study as open and recruiting new participants. The trial was first posted on September 24th, 2021 with the most recent update being October 21st, 2022. At present, there are 35 different locations seeking a total of 408 patients."

Answered by AI

How many different research centers are in charge of this clinical trial?

"Enrolment for this clinical study is currently ongoing at 38 different medical facilities. These locations include Coastal Orthopedics in Bradenton, Florida; Providence Clinical Research in North Hollywood, California; and Affinity Health Corp in Oak Brook, Illinois."

Answered by AI

What are the objectives of this experiment?

"The purpose of this study is to evaluate the efficacy of X0002 spray in reducing pain levels in subjects with osteoarthritis (OA) of the target knee, as measured by the WOMAC pain subscale score. Secondary outcomes include the proportion of responders based on OMERACT-OARSI Responder Criteria definition for pain, Subject's Global Assessment of Disease Status, and average eDiary daily (NRS) score in the target knee. This study will be assessed over a 12-week period."

Answered by AI

Are there any risks associated with taking X0002?

"X0002's safety is estimated to be a 3. This is because it is a Phase 3 trial, meaning that there have been multiple rounds of clinical trials supporting both the efficacy and safety of the medication."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
Illinois
District of Columbia
Other
How old are they?
18 - 65
65+
What site did they apply to?
Biosolutions Clinical Research Center
Orthovirginia
Upstate Clinical Research Associates LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want help with my knees. I have been suffering with this knee pain but scared to take cortisone injection.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Orthovirginia: < 24 hours
  2. DelRicht Research: < 48 hours
Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
~114 spots leftby Mar 2025