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X0002 Spray for Osteoarthritis
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Group A
- Group 2: Group B
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Orthovirginia: < 24 hours
- DelRicht Research: < 48 hours
Typically responds via
Average response time
- < 2 Days
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