A CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN CATS WITH FELINE IDIOPATHIC CYSTITIS

February 16th, 2021 Posted by Pain Management 0 thoughts on “A CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN CATS WITH FELINE IDIOPATHIC CYSTITIS”

Study Specifics

The purpose of this study is to evaluate the safety and pain management effect of a novel therapy administered into the bladder for cats suffering from non-obstructive feline idiopathic cystitis (FIC), with a focus on clinical and behavioral response. Due to its mode of action this novel therapy is known to delete chronic pain pathways, which are responsible for transmitting pain and propagating the inflammation of the bladder cats with FIC . The study involves a one-time treatment with this novel therapy, administered  into the bladder, targeting the nerves responsible for the pain sensation in cats with FIC. The treatment will be administered under general anesthesia.  There is a placebo group in this study. Owners will be required to complete a survey evaluating the cystitis symptoms each week for the duration of the study. The study site will train the owners on evaluation techniques. Study visits include the cats’ initial consultation, treatment day (Day 0), and then recheck visits on Days 14 and 28. Other medications for FIC, except for CBD and other cannabinoids, are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study and no changes in regimen are expected in the next 4 weeks. Each study site will  need to have a masked Investigator and an unmasked Treatment Administrator.


Study Funding

The study is fully funded for the full study duration (28 days). Funding includes the initial consultation, the study treatment and administration, recheck visits, required bloodwork, required imaging, and management of side effects that are thought to be directly related to participation in the study.


Study Eligibility

Trained veterinarians at the study sites will evaluate each cat for eligibility. Cats are eligible if they meet the following inclusion criteria:

  • The cat has active non-obstructive FIC with a minimum of two episodes of FLUTD within the preceding 6 months and is experiencing refractory clinical signs.
  • The cat has signs related to non-obstructive FIC including, but not limited to vocalizing while urinating, inappropriate elimination, dysuria, and / or pollakiuria.
  • The cat reaches the minimum clinical symptom scoring requirements, as assessed by the veterinarian.
  • Urinalysis results show no presence of aggregate crystals. However, occasional crystals on urinalysis are acceptable.
  • Medications commonly used for the treatment of behavioral changes or clinical signs, even if they have been prescribed for another reason (e.g., corticosteroids for a dermatological condition) are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study, and no changes in regimen are expected in the next 4 weeks.
  • If the cat is receiving a TRPV1 agonist or antagonist including but not limited to, cannabinoids (e.g., cannabidiol (CBD), anandamide), a 28-day washout period is required.

 

Cats are not eligible if they meet any of the following exclusion criteria:

  • The cat is less than 12 months of age.
  • The cat’s body weight is less than 2 kg.
  • The cat is unlikely to survive a 30-minute anesthesia or sedation procedure.
  • The cat would be unlikely to survive 4-weeks due to health issues other than FIC.
  • The cat presents with urolithiasis, bacterial infection, bladder neoplasia or congenital deformity.
  • The cat may be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for another reason.
  • The cat is participating in another study.
  • The cat is pregnant or lactating.
  • The cat requires medication or supplements during the course of the study that may interfere with the objective of the study.

 

The Pet Doctor, Inc.
2301 Technology Dr, O’Fallon, MO 63368
(636) 561-9122
https://thepetdoctorinc.com/

A CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN CATS WITH FELINE CHRONIC GINGIVOSTOMATITS

February 16th, 2021 Posted by Pain Management 0 thoughts on “A CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN CATS WITH FELINE CHRONIC GINGIVOSTOMATITS”

Study Specifics

The purpose of this study is to evaluate the safety and analgesic effect of a novel therapy topically administered for the control of pain associated with Feline Chronic Gingivostomatitis, or FCGS. The study involves a one-time treatment with an investigational product administered topically to the oral lesions. The treatment will be administered under sedation or general anesthesia. This study does contain a placebo group, but cats enrolled into this group will have the opportunity to receive the investigational therapy upon study completion. An estimated 40 client-owned cats will be enrolled. Owners will be required to complete daily observation logs for the duration of the study. Study visits include the cats’ initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, and 28.


Study Funding

The study is fully funded for the full study duration (28 days). Funding includes the initial consultation, the study treatment and administration, recheck visits, required bloodwork, and management of side effects that are thought to be directly related to participation in the study.


Study Eligibility

Trained veterinarians at the study sites will evaluate each cat for eligibility. Cats are eligible if they meet the following inclusion criteria:

  • The cat has documented diagnosis of FCGS.
  • The cat is experiencing FCGS clinical signs related to oral pain for at least 3 months following the diagnosis of FCGS.
  • The owner expresses that the cat has experienced a significant decrease in quality of life due to oral pain or is considering euthanasia due to clinical signs related to oral pain (i.e., pain is negatively impacting quality of life).
  • Medications commonly used for the treatment of pain, except for corticosteroids (see Exclusion Criteria), are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study, and no changes in regimen are expected while the cat is in the study.
  • The cat meets the minimum pain scale requirements, as assessed by the study Veterinarian.

 

Cats are not eligible if they meet any of the following exclusion criteria:

  • The cat is less than 12 months of age.
  • The cat’s body weight is less than 2 kg.
  • The cat is unlikely to survive a 30-minute anesthesia or sedation procedure.
  • The cat would be unlikely to survive 4-weeks due to health issues other than oral pain.
  • The cat may be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for another reason.
  • The cat is participating in another study.
  • The cat is pregnant or lactating.
  • The cat has received oral corticosteroids within 1 week of starting the study or injectable corticosteroids within 6 weeks of starting the study and/or requires medication or supplements during the study that may interfere with the objective of the study.
  • The cat has received cannabinoid agonists such as cannabidiol (CBD) or anandamide within 28 days of starting the study.

 

The Pet Doctor, Inc.
2301 Technology Dr, O’Fallon, MO 63368
(636) 561-9122
https://thepetdoctorinc.com/

EXPLORATORY STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF PERINEURAL ADMINISTRATION OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE CONTROL OF HIND LIMB LOCO-REGIONAL PAIN ASSOCIATED WITH BONE CANCER IN CLIENT OWNED DOGS

November 20th, 2020 Posted by Oncology, Pain Management 0 thoughts on “EXPLORATORY STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF PERINEURAL ADMINISTRATION OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE CONTROL OF HIND LIMB LOCO-REGIONAL PAIN ASSOCIATED WITH BONE CANCER IN CLIENT OWNED DOGS”

Investigators:

Corey Saba, DVM, DACVIM (Oncology faculty)
Michele Barletta, DVM, MS, PhD, DACVAA (Anesthesia faculty)

If interested, please have your primary veterinarian request additional information through the UGA Oncology service by calling the small animal referral coordinator at 706-542-5362.

 

Study Description:

Primary bone tumors are common in middle aged to older, large and giant breed dogs.  Pain is often the quality and quantity of life limiting factor in dogs that do not undergo limb amputation. The objectives of this study are to evaluate the safety and effectiveness of pain control of an investigational veterinary product when administered as a single perineural (around the nerve) injection in dogs with primary bone sarcomas of the pelvic limb. Dogs must have a cytology or biopsy confirmed diagnosis of bone sarcoma to be eligible for participation in this study. In addition, the following conditions must be met:

Inclusion criteria:

  • Dogs must be otherwise healthy, have adequate bone marrow and organ function, and be deemed safe to undergo anesthesia.
  • Dogs must be demonstrating refractory pain associated with this cancer at the time of screening/enrollment.
  • Prior treatment with radiation therapy and/or bisphosphonates (e.g. zoledronate) is allowed but requires a 28-day washout period before trial enrollment.
  • Owners must sign a consent form.


Exclusion criteria:

  • Dogs with bone sarcomas at sites other than the pelvic limb (back leg).
  • Dogs that have pathologic fractures secondary to the tumor.

Dogs will undergo preliminary staging tests including initial consultation and physical examination, complete blood count (CBC), serum biochemical profile, urinalysis, and review of radiographs of the affected bone. The study period is 28 days. Once enrolled into the study, the intent will be to administer one treatment while the dog is under general anesthesia. Thereafter, owners will be asked to complete outcome measurement logs and record videos of their dogs once weekly. In addition, dogs must return to UGA 2 and 4 weeks after treatment for exams and additional videos.

Owners are responsible for the costs of initial evaluation and staging. Once a dog is enrolled, the study will cover all routine costs associated with the study including office exams, scheduled lab work, anesthesia and treatment with the investigational veterinary product. Owners will be responsible for the costs of any ancillary medications. Upon completion of the study, owners will be given a $100 gift card.

 

Duration of study:

The study is currently OPEN.

 

Potential benefits to veterinary medicine:

This trial is expected to provide valuable information about the safety and efficacy of perineural an investigational veterinary product for pain control in dogs with primary bone sarcomas. We expect the treatment will be safe. Our ultimate goal is to improve the quality of life of dogs with primary bone sarcomas.

A FUNDED CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN DOGS WITH OSTEOSARCOMA

November 3rd, 2020 Posted by Bone Cancer, Pain Management 0 thoughts on “A FUNDED CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN DOGS WITH OSTEOSARCOMA”

Study Overview

The objective of this study is to assess the pain management effect and safety of a novel combination of compounds dogs with appendicular (front legs or back legs) osteosarcoma. The study involves the pet owners administering the investigational compounds as 3 times weekly subcutaneous injections, for a total of 4 weeks. There is no placebo group in this study.


Study Eligibility

Trained veterinarians at the trial sites will evaluate each dog for eligibility based on the following criteria:

  • The dog has a cytological or histopathological diagnosis of osteosarcoma (high suspicion of OSA on radiographs may also be accepted)
  • Dog has gross appendicular OSA.
  • The dog is at least 1 year old.
  • The dog weighs more than 11 pounds.
  • The dog is feeling reasonably well other than the discomfort associated with the cancer.
  • The dog has a minimum pain index based on interpretation by the study veterinarian and in communication with the owner.
  • Prior glucocorticoid therapy, chemotherapy, bisphosphonates, radiation therapy or small molecule inhibitor therapy is acceptable following a 21-day washout.
  • Prior immunotherapy or targeted monoclonal antibody therapy is acceptable following a 42-day washout.
  • Prior use of NSAIDs are permitted granted the dog has been receiving the current regimen for at least 14 days prior to enrollment. Further, ongoing treatment should maintain the same dosage and treatment schedule as use prior to enrollment.
  • No other major medical problems.

 
*Other study criteria may apply. The veterinary investigator will determine eligibility at the time of consultation.*


Study Funding

If dogs are enrolled, the following funding is provided:

  • Full for the diagnostic tests and procedures required by the study
  • Metabolic therapy, including administration costs
  • Side effects if attributable to the metabolic therapy
  • $1,000 incentive upon completion of the 4-week study and associated owner assessments

A FUNDED CLINICAL STUDY FOR DOGS WITH OSTEOSARCOMA, MELANOMA, SOFT TISSUE SARCOMA, TRANSITIONAL CELL CARCINOMA, OR SQUAMOUS CELL CARCINOMA

November 3rd, 2020 Posted by Oncology 0 thoughts on “A FUNDED CLINICAL STUDY FOR DOGS WITH OSTEOSARCOMA, MELANOMA, SOFT TISSUE SARCOMA, TRANSITIONAL CELL CARCINOMA, OR SQUAMOUS CELL CARCINOMA”

Study Overview

The goal of this study is to assess the safety and preliminary anti-cancer activity of an oncolytic virus administered as an intravenous injection or intravenous and intratumoral injections (if tumors are in locations amenable to injection) Oncolytic viruses are genetically modified to directly destroy cancer cells and recruit immune cells to assist with the anti-cancer effect. In addition, the genetic modification makes these products non-virulent to normal cells.

The study duration is 4 weeks per dog. Enrolled dogs will receive up to 4 weekly treatments during this time. There is no placebo group in this study, which means all dogs receive the oncolytic virus.


Study Eligibility

Trained veterinarians at the trial sites will evaluate each dog for eligibility.

  • Confirmed diagnosis of osteosarcoma, melanoma, soft tissue sarcoma, transitional cell carcinoma, or squamous cell carcinoma.
  • At least 1 year old.
  • Weighs more than 11 pounds.
  • At least one measurable lesion greater than 2 cm.
  • Dogs has not received anti-cancer therapy within 3 weeks of enrollment.
  • Prior surgery to remove mass(es) is permitted so long as the procedure was performed at least 14 days prior to enrollment and measurable disease remains.
  • Prior use of NSAIDs are permitted provided the dog has been receiving the current regimen for at least 30 days prior to enrollment.
  • No other major medical problems.
  • Has not received routine vaccinations within 14 days prior to enrollment.

*Other study criteria may apply. The veterinary investigator will determine eligibility at the time of consultation.*


Study Funding

If dogs are enrolled, the following funding is provided:

  • Screening tests required by the study
  • Oncolytic virus including administration costs
  • Study-related exams and diagnostics (e.g. Bloodwork, radiographs “x-rays”, abdominal ultrasound).
  • Side effects if attributable to the oncolytic virus

A CLINICAL RESEARCH STUDY FOCUSING ON PAIN MANAGEMENT IN DOGS LIVING WITH OSTEOARTHRITIS OF THE ELBOW

January 17th, 2020 Posted by Pain Management 0 thoughts on “A CLINICAL RESEARCH STUDY FOCUSING ON PAIN MANAGEMENT IN DOGS LIVING WITH OSTEOARTHRITIS OF THE ELBOW”

Trial Overview

This study aims to confirm the effectiveness and safety of a new medicine to control pain associated with osteoarthritis of the elbow in dogs. If your dog qualifies for this study, you should expect to stay in the study for 90 days and have 7 scheduled visits with the veterinarian conducting the study. You will also be required to provide weekly behavioral assessments of your dog.

Because this is a study that is intended to support the drug’s approval, it needs to be “controlled”. This means some dogs receive treatment and others undergo the preparation and everything leading up to an injection of the medication, but do not actually receive the medication being tested. This study is also “blinded” or “masked”, meaning neither you nor the veterinarian making observations will know if your dog received the treatment or not until the end of the study. All owners of the untreated dogs will be given an opportunity at the end of the study for their dogs to receive the investigational treatment at no charge.

More than 200 dogs have been treated with the drug in safety studies, including pet dogs with elbow pain. This study is primarily focused on confirming the effectiveness of the drug. All dogs will be closely monitored and treated, in the event of any side effect. Please feel free to discuss any hesitations with the treating veterinarian, and if at any time prior to treatment you decide not to enroll your dog, you can do so at no charge and with no questions asked.


Trial Eligibility

Trained veterinarians at the trial sites will evaluate each dog for eligibility.

  • At least 1 year old.
  • Weighs more than 11 pounds.
  • Confirmed diagnosis of bilateral elbow pain due to osteoarthritis impacting mobility and quality of life.
  • If suffering from additional conditions other than joint pain, those conditions are stable and under medical care.
  • Is not intended for breeding and is not pregnant or lactating.
  • Has not had a medical or surgical procedure in the past 30 days.

 
*Other study criteria may apply. The veterinary investigator will decide if your dog is a good candidate for this study after examination.*


Trial Funding

If qualified, your dog would receive (at no cost to you):

  • Investigational medicine or the procedure without injection of the medication.
  • Study-related exams and tests.
  • Time with a local veterinarian.


Participating Sites

Veterinary Specialty Hospital
10435 Sorrento Valley Rd, San Diego, CA 92121
Phone: (858) 875-7500

Advanced Care Veterinary Services
1609 West Hebron Parkway; Ste 108, Carrollton, TX 75010
Phone: (972) 394-6422

Limestone Companion Animal Hospital
4224 Airport Rd, Bartonville, IL 61607
Phone: (309) 697-8000

Quakertown Veterinary Clinic
2250 N. Old Bethlehem Pike, Quakertown PA 18951
Phone: (215) 536-6245

Bradford Park Veterinary Hospital
1255 E. Independence, Springfield, MO 65804
Phone: (417) 886-0777

BluePearl Pet Hospital
3000 Busch Lake Blvd, Tampa, FL 33614
Phone: (813) 933-8944

BluePearl Pet Hospital
9500 Marketplace Road, Fort Myers, FL 33912
Phone: (239) 947-0588

Midwestern University Companion Veterinary Clinic
5715 W. Utopia Rd., Room 202, Glendale, AZ 85308
Phone: (623) 806-7387

Veterinary Specialty Hospital of the Carolinas
6405-100 Tryon Road, Cary, NC 27518
Phone: (919) 233-4911

Franklin Animal Clinic
2990 N Morton St, Franklin, IN 46131
Phone: (317) 736-9246

Veterinary Specialty and Emergency Clinic
625 Ridge Pike, Building B, Conshohocken, PA 19428
Phone: (484) 567-7998

Animal Care Center
562 East Castle Pines Pkwy #C5, Castle Rock, CO 80108
Phone: (303) 688-3660

KIDNEY DISEASE SAMPLE COLLECTION PROJECT

January 17th, 2020 Posted by Other 0 thoughts on “KIDNEY DISEASE SAMPLE COLLECTION PROJECT”

Project Overview

The project is being conducted by ACI and involves collection of blood and kidney samples in cats and dogs with all stages of Chronic Kidney Disease (CKD) and/or acute kidney injury (AKI). The objective is to identify differentially expressed genes and over-represented pathways contributing to this disease in pets.


Project Details

Dogs and cats of any breed, age or sex are eligible so long as they are at least 1.5 kg and have CKD or AKI of any IRIS stage.  Prior to enrollment, the owner must provide written consent for participation.  A CBC/Chemistry/Urinalysis will be sent to a central lab before the day of euthanasia or on the day of euthanasia to confirm CKD stage.  There is an option to run in-house bloodwork to confirm the presence of CKD or AKI so long as an additional sample is sent to a central lab for analysis.  Immediately ante-mortem, up to 4ml of blood will be collected for serum and plasma.  These samples will be stored at -20C and eventually batch shipped.  Following euthanasia (within 1 hour), both kidneys will be removed for formalin and RNAlater processing.  These samples will also be batch shipped.

Additionally, the project is designed to collect serum, plasma and kidneys from 15 dogs and 15 cats that are euthanized without having CKD or AKI.  Samples for these pets will also be processed according to the plan above.


Project Compensation

Owner incentive

  • Free euthanasia and cremation
  • Free CBC/chemistry/Urinalysis
  • Donation in pet’s name

 
Site compensation (per case)

  • Blood and urine collection (submit to central lab – collection only)
  • In-house CBC/chemistry if necessary
  • Serum/plasma collection for genetics analysis
  • Serum/plasma sample processing
  • Kidney sample collection (if collected by non-ACI personnel)
  • Kidney sample processing (formalin and RNA storage)
  • Completion of case report forms (if site completes paper only)
  • Completion of case report forms (if entered electronically)
  • ACI will pay for batch shipping of all samples


Participating Sites

Olney Sandy Spring Veterinary Hospital
1300 Olney Sandy Spring Rd.
Sandy Spring, MD 20860
Phone: (301) 774-9500

Quakertown Veterinary Clinic
2250 North Old Bethlehem pike
Quakertown, PA 18951
Phone: (215) 536-6245

Wilson Veterinary Hospital – West
12000 Durham Road
Washington Twp., MI 48095
Phone: (586) 752-6217

Animal Hospital of Dauphin County
241 South Hershey Road
Harrisburg, PA 17112
Phone: (717) 652-1270

Liverpool Animal Health Center
8205 Oswego Rd
Liverpool, NY 13090
Phone: (315) 622-2882

Bradford Park Veterinary Hospital
1255 East Independence St.
Springfield, MO 65804
Phone: (417) 886-0777

Coming Soon

Nothing at this time.