Do you have knee pain
due to osteoarthritis?

You might be a candidate for the study if you:
- are between 40 to 80 years old
- are willing to fill out an e-diary every evening for 16 weeks
- are willing to set time aside to visit a clinic 7 times within 20 weeks
- are willing to avoid other medication than the study medication and Acetaminophen/Paracetamol during the study period
- have not received one or more injections in one or both knees during the past 3 months
- do not have knee surgery scheduled during the period of the study
- have experienced knee pain on most days for at least 6 months before signing up for the study

Sponsor:
Biosplice Therapeutics, Inc are the sponsor of the study. The study is conducted by NBCD in collaboration with Studies&Me

Phase:
Phase 3

Duration:
The duration of the study is 20 weeks
The screening period may last up to 28 days

Is a placebo being used?
Yes. Participants are divided into two groups. One of these groups will receive a placebo.

Will the results of the study be published?
Yes

Will participants be able to continue taking the medication after the trial?
No

Purpose of the study
The study will evaluate a potential osteoarthritis treatment that is being developed to potentially reduce the pain of the affected knee.
The investigated treatment consists of a single injection into the affected knee. The injection will be given under ultrasound guidance. The result of the study may help researchers to develop treatments to improve the symptoms and quality of life of people living with osteoarthritis

What will happen at the clinic?
While visiting the clinic, a healthcare professional will conduct a knee examination, including an x-ray, to assess whether your knee pain is due to osteoarthritis, and to determine the severity of your condition. Furthermore, your medical history will be obtained.
The healthcare professionals at the clinic will also inform you about the study in detail, including what participation entails. If they assess that your condition matches the criteria for participation, you will then decide whether you are willing to participate or not.

What if I regret my sign-up?
Signing up for the study online and answering the questions does not oblige you to participate in the study and you have the right to withdraw from the study at any time and for any reason during the study.

How many will participate?
Approximately 550 participants with moderate to severe osteoarthritis will participate in the study.

Treatment or placebo?
The 550 participants will be enrolled and randomized into 1 of 2 treatment groups, where one of the groups will receive a placebo.

What is expected of me?
During the study you will visit the clinic seven times and you will score your pain level on a daily basis from home, via a tablet that will be handed out at the second visit in the clinic.

All study-related medications, analyses, clinic visits, and procedures will be provided at no cost. Travel compensation for participation will be provided and can be discussed with the study personnel at the clinic.

Yes, the confidentiality and protection of participant information is a priority in clinical trials. Clinical trial data is often protected by federal laws, such as the Health Insurance Portability and Accountability Act (HIPAA) in the US, which regulates the handling and storage of participant information. In addition, clinical trials typically have confidentiality agreements in place, and participants' data is usually de-identified to protect their privacy.

A clinical trial is a type of research study that investigates a new medical treatment, drug, or device in human volunteers. The goal of a clinical trial is to determine the safety and efficacy of the treatment being studied, as well as to gather information about its side effects. Participants are carefully selected and monitored throughout the trial to ensure their safety and well-being.

Eligibility for a clinical trial varies depending on the study. Factors that may be considered include age, gender, medical history, and current health status.

Benefits of participating in a clinical research project include:
- The possibility of receiving experimental treatments that may be more effective than current treatments
- The opportunity to contribute to medical research and potentially help others in the future
- Close monitoring of health by study staff
- Access to new diagnostic tests or treatments
- Reimbursement for time and travel expenses


Risks of participating in a clinical research project include:
- The possibility of experiencing side effects from the treatment being studied
- The chance that the experimental treatment may not be effective
- The risk that the study may not provide any direct benefit to the participant

It is important to note that all clinical research projects are subject to oversight by institutional review boards (IRBs) or ethics committees to ensure the protection of the rights and welfare of the participants. It is also important for the participant to understand the details of the study before making the decision to participate, which will include an informed consent process.

Yes, participants in a clinical research project have the right to withdraw from the study at any time, for any reason, without penalty or loss of future medical care. This is known as the right to "informed consent," and it means that participants are informed about the study and are able to make an informed decision about whether or not to participate.

They also have the right to stop participating at any point after they have started. The participant should inform the study staff if they decide to withdraw from the study, and in some cases, the study staff will ask the participant to undergo a follow-up examination or procedure to ensure the participant's safety. If a participant leaves a study, they will still be followed up by the research team to ensure their safety and well-being.

A placebo is an inactive substance that is used in some clinical trials as a control to compare the effects of an experimental treatment. Participants in a clinical trial may be randomly assigned to receive either the experimental treatment or a placebo. The purpose of using a placebo is to determine if the experimental treatment has a real effect on the medical condition being studied or if any observed changes are due to other factors, such as natural disease progression or the placebo effect.

The amount of time required to participate in a clinical trial can vary depending on the specific study and the individual participant. Some clinical trials may only require a few visits over several weeks, while others may require more frequent visits and last several months or even years. Make sure to get information about the study duration as part of the informed consent process.

It can be disappointing to hear that you're not eligible for a clinical trial that you're interested in, but it's important to remember that not everyone can participate in every trial. Every trial has specific criteria for inclusion and exclusion, and if you don't meet those criteria for one trial, it doesn't mean that you're not a valuable person or that you won't benefit from a trial in another way.

The good news is that there are often other trials in your area that you may be eligible for. You can speak to your doctor or healthcare team to explore other options that might be a good fit for you. They can also help you understand why you weren't eligible for the trial you were initially interested in and what steps you can take to increase your chances of participating in future trials.

Studies&Me is a platform that connects patients with clinical research studies across the world. Studies&Me cooperates with multiple clinics that carry out clinical research and we only work with clinical research studies that have been approved by institutional review boards (IRBs) or ethics committees to ensure the protection of the rights and welfare of the participants.

The study has been approved by the local institutional review board, and is registered on clinicaltrials.gov.