What is a veterinary clinical TRIAL?


​A veterinary clinical trial is a scientific investigation conducted to evaluate the safety and efficacy of a drug, treatment, or procedure in animals. 

We have a strong work ethic where integrity and commitment to animal welfare are paramount.
​We ensure that our developments are scientifically sound and contribute to animal well-being.
​Therefore, everything we do is tested multiple times and backed by data. 

​More info: [email protected] o +598 096 498 300



 The objective of the study  is to validate the development of Xep01, for the treatment of chronic pain associated with osteoarthritis in dogs.


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​The treatment consist of the Xep01 vaccine that stimulates the production of antibodies that decrease pain and inflammation in vaccinated dogs. 



​All costs associated with the study, such as diagnosis, laboratory analysis during the trial, and clinical follow-up, will be covered by the sponsoring company.

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WHO CAN PARTICIPATE IN OUR CLINICAL TRIAL?

Inclusion criteria
  • Presents pain in any joint or area of the spine (with at least 3 months of evolution), with moderate intensity.

  • Presents limping without neurological alterations. 
 
  • Does not suffer from additional diseases (such as infectious, autoimmune, cardiac, renal, hepatic, neurological, etc.) at the time of the recruitment.
 
  • Resides in Montevideo or the Metropolitan Area. 
 
  • Is under 14 years of age. 
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  • Weighs more than 8 kilograms. 
exclusion criteria
  • Patients who have concomitant diseases (infectious-contagious, neurological, renal, oncological, etc)

  • Patients whose guardians plan to make changes of residence, introduction of new pets or people to the home, or plan to travel during the course of the trial. 
 
  • Canines that do not positively tolerate manipulation and interaction with the Veterinarian. 
 
  • Pregnant, lactating or breeding females that will be used during the course of the trial. 
 
  • Patients who have participated in any clinical trial in the last 30 days, were previously treated with monoclonal antibodies, and/or who may potentially present any adverse reaction to the active principle. 
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  • Canines that are undergoing tratment with any type of corticosteroids that cannot be interrupted and those that during the clinical trial period are immunized (annual vaccine).

what do we know about the efficacy ​
​and security of ​our technology?



​Previous animal studies have demonstrated that the Xep01 vaccine is safe, well-tolerated, and effective for treating pain associated with canine osteoarthritis. 

The vaccine has been shown to provide long-lasting pain relief, improve mobility and anial well-being, and reduce the need for pain medication in dogs with advanced osteoarthritis.

Most recently, a safety pilot trial in healthy dogs confirmed that vaccination with Xep01 does not cause any significant local or systemic adverse effects.

Overall, the evidence from these studies supports the safety and efficacy of the Xep01 vaccine for managing pain and improving outcomes in canine osteoarthritis patients.

FAQs

How can I ARRANGE FOR my DOG to participate in the clinical trial?
It's very simple! You just need to call 096 498 300, and we will be happy to assist you. Initially, we conduct an evaluation preferably through WhatsApp or a phone call, where we exchange information and details to determine if your dog meets the participation criteria.
How can I coordinate a visit?
If during the first evaluation we confirm that your dog meets the criteria, our clinical team will schedule a home visit to get to know them better. For those residing in Montevideo and the metropolitan area, our veterinarians will come to your home.
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For logistical reasons, we do not conduct visits to other departments. However, if you are available and the transfer is not stressful for your dog, we can arrange for visits to be at the Faculty of Veterinary Medicine.
What prior studies do I need?
This time, we are looking for dogs diagnosed with osteoarthritis in the spine, hips, or joints (elbows, shoulders, wrists, and knees). If you already have X-rays or images, our team will be happy to review them to assess whether the diagnosis is compatible.

If your pet does not have prior studies, don't worry. We can analyze the symptoms through videos and some questions. If necessary, and after coordinating a visit, our clinical team will take care of managing the required X-rays or images.
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We want the process to be as easy and comfortable as possible. We are here to help you at all times!
Why might my dog not qualify?
To ensure the safety and effectiveness of the study, there are some criteria that may exclude certain dogs from participation:
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  • Age: If your dog is 14 years old or older, they cannot participate.
  • Pre-existing conditions: Dogs with additional diseases such as chronic allergies, kidney disease, seizures, heart problems, or neurological issues cannot participate. Symptoms and conditions unrelated to their osteoarthritis.
  • Behavior: If your dog shows defensive reactions that make approaching difficult, such as extreme distrust, aggression to touch, or requires the use of a muzzle.
  • Severity of pain: If they suffer from very intense pain or have severely reduced mobility (requiring analgesics or anti-inflammatories regularly, losing stability, falling occasionally, dragging their legs, or self-harming due to pain).​
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If you have doubts about whether your dog meets the requirements, do not hesitate to consult us. We are here to help!
How long does the clinical trial last?
The trial lasts approximately 84 days, during which your dog will be under continuous veterinary monitoring to ensure their well-being. Once their participation is confirmed, we will organize a personalized schedule with all the dates.

The treatment consists of 4 injections, administered every two weeks, and 6 scheduled veterinary visits every 14 days. These can be conducted at the Faculty of Veterinary Medicine clinic or at home, depending on what is most comfortable for you and your pet.

Do the evaluation and treatment have any cost?
No! The entire process, from the initial evaluation to the complete treatment, is completely free. However, if studies are required that are unrelated to osteoarthritis and outside the clinical trial, these will be at the expense of the guardians.
How do you ensure the safety of the dogs during the trial?
The well-being of your pet is our priority. Therefore, each participating dog is in the hands of highly trained and dedicated veterinarians who supervise the entire process responsibly. Each stage of the study is designed to ensure that the dogs feel comfortable, safe, and well cared for at all times.
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Additionally, this treatment has successfully passed a prior safety phase, ensuring that it poses no risks to the dogs. As with any veterinary application, it is important to follow some post-care instructions, such as protecting the vaccination site and avoiding prolonged sun exposure. The only possible reaction is slight local inflammation, similar to any annual vaccine, which disappears within a few days. Good home care is key to their recovery.