Posts by catharine

SAFETY OF AN INVESTIGATIONAL VETERINARY PRODUCT (IVP) IN PET DOGS WITH NATURALLY OCCURRING CANCER

November 10th, 2021 Posted by Oncology 0 thoughts on “SAFETY OF AN INVESTIGATIONAL VETERINARY PRODUCT (IVP) IN PET DOGS WITH NATURALLY OCCURRING CANCER”

Study Specifics

This is a non-randomized, open label, dose escalation proof of concept clinical study to evaluate the safety and potential efficacy of an investigational veterinary product for treatment of osteosarcoma, melanoma, transitional cell carcinoma and squamous cell carcinoma in dogs. A client-owned dog must have a cytology or biopsy confirmed diagnosis of one of the aforementioned cancers to be eligible for participation in this study. Dogs will undergo clinical screening at study site. Preliminary staging tests will include initial consultation, physical examination with target lesion (tumor) measurements, complete blood count (CBC), serum biochemical profile, thoracic radiographs, and abdominal ultrasound. Once enrolled into the study, the IVP will be administered once weekly for 6 treatments total. Dogs will be monitored as appropriate following treatment. Once the treatment course has been completed, dogs will return 2-weeks (Day 56), then 4 weeks later (Day 84) for recheck exams and tumor measurements. The total study period is 84 days. Owners will be required to report and record abnormal daily observations and complete questionnaires relating to their dog’s pain level throughout the study. 


Funding

This study is fully funded. Funding includes the initial study screening, the study treatment and administration, scheduled study lab work, recheck visits and exams, and management of side effects that are thought to be directly related to participation in the study. 


Eligibility

Dogs may be eligible if they meet the following inclusion criteria: 

  • ≥ 1 year of age and weigh at least 5 kg
  • Have at least one measurable lesion with a longest diameter of ≥ 20 mm at screening.
  • Have a VCOG Performance Score of 0 or 1 at screening.
  • Prior treatment is acceptable; however a treatment washout period may apply before trial enrollment.
  • Must not have another underlying disease that could affect the study objectives.
  • Owner must sign informed consent.

 

University of Georgia
Veterinary Teaching Hospital
Athens, GA 30602
(706) 296-7818 

University of Wisconsin – Madison
School of Veterinary Medicine
Madison, WI 53715
(608) 263-9754 

Tufts University
Cummings School of Veterinary Medicine
North Grafton, MA 01536
508-887-4498 

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

PILOT SAFETY AND EFFECTIVENESS STUDY OF A NOVEL STEM CELL THERAPY PREPARATION IN CLIENT-OWNED CATS WITH CHRONIC KIDNEY DISEASE (CKD)

November 10th, 2021 Posted by Chronic Kidney Disease 0 thoughts on “PILOT SAFETY AND EFFECTIVENESS STUDY OF A NOVEL STEM CELL THERAPY PREPARATION IN CLIENT-OWNED CATS WITH CHRONIC KIDNEY DISEASE (CKD)”

Study Specifics

This GCP study conducted at multiple clinical study sites will evaluate the safety and effectiveness of a novel stem cell therapy preparation in cats with naturally occurring chronic kidney disease (CKD). The study veterinarian will administer the stem cell therapy by intravenous injection on Day 0 and 14. The study will compare the investigational veterinary product (IVP) to a placebo control product (CP). Cats at a given clinic will be randomly assigned to treatment group with a 2:1 group enrollment ratio. Follow-up visits/testing or phone follow-ups are required monthly. Throughout the study the owner will be required to observe and record any abnormal observations and assess food and water intake.


Funding

This is a fully funded study that includes seven scheduled clinic visits occurring at least once before treatment for screening (2 to 3 weeks prior), once for each treatment (Day 0 and 14), and four times thereafter (Days 30, 60, 90, 180). Funding includes the initial consultation, the study treatment and administration, recheck visits, and management of side effects that are thought to be directly related to participation in the study. 


Eligibility

Cats that meet eligibility criteria and have a diagnosis of stage 2 or 3 CKD with no other diseases that would interfere with the study objectives, may enroll in the study. The study veterinarian will determine the stage of the cat’s kidney disease and discuss the complete list of study requirements. 

Friendship Hospital for Animals
4105 Brandywine St NW
Washington, DC 20016
(202) 363-7300 

Quakertown Veterinary Clinic
2250 N. Old Bethlehem Pike
Quakertown, PA 18951
(215) 515-8810 

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

DOSE DETERMINATION STUDY: INVESTIGATING THE USE OF PERI-NEURAL (PN) ADMINISTRATION OF RESINIFERATOXIN (RTX) FOR THE CONTROL OF CLINICAL SIGNS ASSOCIATED WITH NAVICULAR SYNDROME IN HORSES

November 9th, 2021 Posted by Pain Management 0 thoughts on “DOSE DETERMINATION STUDY: INVESTIGATING THE USE OF PERI-NEURAL (PN) ADMINISTRATION OF RESINIFERATOXIN (RTX) FOR THE CONTROL OF CLINICAL SIGNS ASSOCIATED WITH NAVICULAR SYNDROME IN HORSES”

Study Specifics

This is a non-GCP, randomized, masked, placebo-controlled study in client owned horses with a history of refractory navicular disease. The objective of this study is to evaluate the effectiveness and safety of an investigational veterinary product to control pain when administered perineurally to horses with refractory navicular disease or who are candidates for a neurectomy due to refractory navicular disease. Screening activities will take place at least 24 hours prior and up to 14 days in advance of treatment administration on Day 0. This 60-day study involves a one-time injectable treatment of investigational veterinary product administered to both forelimbs. An estimated 30 client-owned horses will be enrolled. After receiving treatment on Day 0, the horse will be required to either remain in the clinic until Day 3 or return to the study site on Days 3, 14, 28, and 60 for follow up evaluation visits. Owners will be required to report and record abnormal daily observations throughout the study. As necessary, the horse may return for additional evaluation during unscheduled visits. 


Funding

The study is fully funded for the entire duration of the study. Study visits includes the initial study consultation, treatment Day 0, evaluation visits on Day 3, 14, 28, and 60. In addition to management of side effects that are thought to be directly related to participation in the study. 


Eligibility

Horses are eligible if they meet the following inclusion criteria: 

  • Written informed owner consent has been obtained prior to screening procedures.
  • The horse is at least 2 years old.
  • In general good health or stabilized for chronic conditions as assessed by physical examination, medical history and clinical pathology evaluations.
  • Lack of response to treatment of navicular disease and/ or owner considering neurectomy as treatment for chronic navicular disease.
  • Unilateral or bilateral forelimb lameness of Grade 2, 3, or 4 using the AAEP Lameness Scale (0 to 5 scale).
  • Positive response to anesthesia of the medial and lateral distal palmar digital nerves of the affected forelimbs.
  • Radiographic evidence of degenerative changes associated with navicular disease (e.g. elevated number of or abnormally shaped lucent zones, subcortical stenosis, enthesiophyte formation of the navicular bone) in one or both navicular bones.

 

Horses are not eligible if they meet the following exclusion criteria: 

  • Hindlimb lameness or lameness other than in the front hooves that could confound the lameness exams
  • Horse is less than 2 years of age
  • A change in shoeing or trimming within 2 weeks of enrollment. Shoeing and trimming are required to remain consistent throughout the study.
  • Use of medications to treat navicular disease or drugs that could mask lameness (e.g. NSAIDs, isoxsuprine, steroids, clodronate (Osphos), tiludronic acid (Tildren)) within 2 weeks of starting the study
  • Evidence of a neurectomy
  • History of episodes of colic in the past 4 weeks preceding treatment with RTX
  • May be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for any other reason

 

McKey Equine Hospital
107793 S 4570 Rd.
Sallisaw, OK 74955
(918) 773-6460
https://mckeyequine.com/contact/

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

EVALUATING A NOVEL PET FOOD IN DOGS WITH DIFFERENT TYPES OF CANCER OR BENIGN TUMORS

November 9th, 2021 Posted by Oncology 0 thoughts on “EVALUATING A NOVEL PET FOOD IN DOGS WITH DIFFERENT TYPES OF CANCER OR BENIGN TUMORS”

Study Specifics

Benign and malignant tumors are common in dogs, which may or may not be associated with alterations in appetite. The purpose of this study is to evaluate a novel pet food in dogs with different types of cancer who are reported by their owner to have a normal or decreased appetite. A dog may be a possible candidate for this study, if they have been diagnosed with cancer or have a benign tumor. The study will be a multi-center clinical study conducted in at least 15 general and specialty practices in the United States. The intent is to include at least 90 total evaluable dogs in this study. Clinical study sites are expected to enroll a minimum of 5-10 dogs. 

Pet owners will receive the diet to feed their dog over a 28-day study period along with a scale to properly weigh the food. There is no “placebo diet”. Bloodwork will be collected on Day 1 and Day 28 for CBC and blood chemistry. Pet owners will be required to complete a daily log for the first 10 days of the study along with Day 14, Day 21, and Day 28. These logs will include an assessment of the amount of food eaten, enthusiasm for eating, quality of life, and stool quality. 


Funding

Your dog will receive the study diet and bloodwork described above free of charge. If your dog has a side effect that is related to the study diet, care for this side effect will be provide at no additional cost. 


Eligibility

Dogs are eligible if they meet the following inclusion criteria: 

  • Owner consent form is signed for the pet to participate in the study.
  • Is at least 1 year of age.
  • Is the only pet in the home OR owner agrees to feed the pet separately for the duration of study.
  • All current medications (including non-prescription supplements) have been disclosed to the veterinarian/investigator and there is an understanding that changes to medication including changes in dosing may result in dismissal from the study.
  • Owner is willing (at their expense) to maintain any current medications at their current dosing throughout the study without alteration and understands that any additional medications will not be reimbursed during the study unless approved or pre-approved by the study Sponsor.
  • Pet treats will be limited to less than 10% of daily food offered and food is fed as directed during the study.
  • Owner has a working email address, is willing to regularly check it, and consents to receiving necessary study-related communication through email.
  • Owner reports owning and is proficient in using a smartphone (Android or Apple only) which is 4 years old or newer.
  • Owner agrees to download and use study Apps. Pet parent(s) express that they are willing, able, and have experience setting up a Wi-Fi enabled App/device.
  • Owner consents to text messaging back and forth for any necessary study-related communication/troubleshooting.
  • Understanding that Wi-Fi, texting, or data cell phone charges while participating in this study will NOT be reimbursed.
  • Dog has history of cancer with a diagnosis as to cancer type including determination of whether the cancer is malignant or benign. OR a presumptive diagnosis can be made at time of enrollment and diagnostics are pending.
  • Dog’s owner DOES NOT elect referral for advanced therapy including interventions such as surgery, chemotherapy and/or radiotherapy where that treatment would interfere with the first 10 days of data collection and those days being free of medication except NSAIDs or topical or eye medications. Or dog is in remission.

 

Dogs are not eligible if they meet the following exclusion criteria: 

  • Has participated in any other clinical trials within the last 6 months.
  • Currently in need of hospitalization for underlying disease condition(s).
  • Plans scheduled surgery during the study timeframe.
  • Has a major concurrent systemic disease or condition, acute traumatic injuries, or intestinal parasites.
  • Has history of an unknown illness or a current illness that is not likely to obtain a diagnosis.
  • Is a fractious animal.
  • Is pregnant or likely to become pregnant during the trial period; the pet is lactating or nursing.
  • Expected to be boarded at any point during the study period or the pet lives partially or exclusively outdoors.
  • Currently receiving any therapeutic pet foods intended to manage specific disease conditions, except those for weight, dental tartar control, or those deemed acceptable.
  • Is unwilling or unable to exclusively consume the study food.
  • Has a history of complete surgical removal of their tumor.
  • Dogs will have surgery, chemotherapy, or radiotherapy where that treatment would interfere with the first 10 days of data collection and those days being free of medication except NSAIDs.
  • Dog has complete anorexia of multiple days duration and/or clinical evidence of dehydration and in need of intravenous fluid or immediate medical intervention.
  • Has active case of or history of pancreatitis.
  • Deemed by the veterinarian to necessitate appetite stimulating medications at the time of the first visit or is completely inappetant.
  • Cancer will not have a definitive diagnosis.
  • Unable to exclusively consume the study food due to an oral tumor or advanced gingivitis or has painful, infected teeth.
  • Has a nasal tumor that might interfere with his/her sense of smell.

 

Chippens Hills Veterinary Clinic
595 Clark Ave
Bristol, CT 06010
(860) 850-2187 

Friendship Hospital for Animals
4105 Brandywine St, NW
Washington, DC 20016
(202) 363-3700 

Kindness Animal Hospital
2130 University Blvd
Wheaton, MD 20902
(301) 949-2511 

Quakertown Veterinary Clinic
2250 N. Old Bethlehem Pike
Quakertown, PA 18951
(215) 515-8810 

Veterinary Cancer Group
2887 Edinger Ave
Tustin, CA 92780
(949) 552-8274 

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

PROOF OF CONCEPT STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF ORAL MUCOSA AND CUTANEOUS TOPICAL APPLICATION OF RESINIFERATOXIN (RTX) FOR THE CONTROL OF PAIN AND INFLAMMATION IN DOGS UNDERGOING RADIATION THERAPY

November 9th, 2021 Posted by Pain Management 0 thoughts on “PROOF OF CONCEPT STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF ORAL MUCOSA AND CUTANEOUS TOPICAL APPLICATION OF RESINIFERATOXIN (RTX) FOR THE CONTROL OF PAIN AND INFLAMMATION IN DOGS UNDERGOING RADIATION THERAPY”

Study Specifics

This is a study to determine the safety and effectiveness of an investigational veterinary product for the control of pain and inflammation associated with radiation therapy. A client-owned dog may be a possible candidate for the study if it appears to be suffering from pain and inflammation associated with radiation burns in the oral mucosa and or skin following radiation therapy. This study does not include a control group. An estimated 9 to 18 dogs will be enrolled. This 28-Day study involves a one-time topical application with investigational product under general anesthesia or sedation. Dogs will be monitored as appropriate following treatment. Dogs will be required to return to study site on Day 7, 14, and 28 for follow up evaluations. Owners will be required to report and record abnormal daily observations and complete questionnaires relating to their dog’s pain level throughout the study.


Funding

The study is fully funded for the entire duration of 28 days. Study visits include the dog’s initial consultation, treatment Day 0, follow up evaluation visits on Day 7, 14, and 28, and management of side effects that are thought to be directly related to participation in the study. 


Eligibility

Dogs are eligible if they meet the following inclusion criteria:

  • Written owner/legal representative informed consent is obtained prior to screening activities.
  • The dog has documented diagnosis of radiation burns or pain post radiotherapy.
  • The dog is experiencing pain and inflammation related to radiation burns.
  • 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 dog is in the study (unless RTX is not effective in controlling pain and inflammation related to radiation burns).
  • The dog has a composite VSOM for 3 activities selected by the Investigator of 10 or higher or a composite CSOM for 3 activities selected by the owner as 10 or higher.

 

Dogs are not eligible if they meet the following exclusion criteria:

  • Less than 12 months of age.
  • Unlikely to survive a 30-min anesthesia or sedation procedure.
  • Unlikely to survive 4-weeks.
  • May be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for another reason.
  • Is participating in another study.
  • Is pregnant or lactating.
  • 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, such as but not limited to, CBD products, during the study that may interfere with the objective of the study.

COLLECTION OF CYTOLOGY SAMPLES FROM DOGS WITH VARIOUS MEDICAL CONDITIONS

November 5th, 2021 Posted by Sample Collection 0 thoughts on “COLLECTION OF CYTOLOGY SAMPLES FROM DOGS WITH VARIOUS MEDICAL CONDITIONS”

Study Specifics

The study is a sample collection study conducted at 10 different ACI-affiliated clinics.  Oncology, Dermatology and Emergency clinics are involved.  1500 samples will be collected from cats and dogs.


Study Funding

The study provides a $20 stipend to owners who consent to a sample collection from their pet.


Study Eligibility

Any pet with a lesion in which routine cytology collection can be obtained is eligible
The Oncology Service Hospitals – Leesburg
134 Fort Evans Rd NE
Leesburg, VA 20176
(571) 439-6655

Las Vegas Veterinary Specialty Center
8650 W. Tropicana Ave B-107
Las Vegas, NV 89147
(702) 871-1152

Veterinary Cancer Group Tustin
2887 Edinger Ave
Tustin, CA 92780
(949) 552-8274

Southeast Veterinary Dermatology and Ear Clinic – Charlotte
9201-B S. Tryon St
Charlotte, NC 28273
(704) 588-7004

Southeast Veterinary Dermatology and Ear Clinic – Greenville
393 Woods Lake Rd
Greenville, SC 29607
(864) 385-6565

Veterinary Dermatology of Richmond
5918 W Broad St
Richmond, VA 23230
(804) 740-9555

Additional study sites coming soon!

A CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN CATS WITH FELINE CHRONIC GINGIVOSTOMATITIS (CAUDAL STOMATITIS)

November 5th, 2021 Posted by Pain Management 0 thoughts on “A CLINICAL STUDY FOR THE MANAGEMENT OF PAIN IN CATS WITH FELINE CHRONIC GINGIVOSTOMATITIS (CAUDAL STOMATITIS)”

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 (Caudal Stomatitis). 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 not contain a placebo group. 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, short-acting analgesic therapy for three days post-treatment (as needed), 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 (Caudal Stomatitis).
  • The cat is experiencing FCGS (Caudal Stomatitis) clinical signs related to oral pain for at least 3 months following the diagnosis of FCGS (Caudal Stomatitis).
  • 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 cat underwent an oral surgical procedure within 30 days prior screening.

 

The Cat Care Clinic
2638 N Tustin St
Orange, CA 92865
(714) 282-2287
office@catcare.com

Veterinary Dental Specialties & Oral Surgery
5775 Chesapeake Ct
San Diego, CA 92123
(858) 279-2108
https://www.dogbeachvet.com/

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

AN EXPLORATORY FIELD STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF CONCOMITANT INTRA-ARTICULAR (IA) AND PERI-NEURAL (PN) INJECTIONS OF RESINIFERATOXIN (RTX) FOR THE CONTROL OF ELBOW PAIN IN DOGS

October 25th, 2021 Posted by Pain Management 0 thoughts on “AN EXPLORATORY FIELD STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF CONCOMITANT INTRA-ARTICULAR (IA) AND PERI-NEURAL (PN) INJECTIONS OF RESINIFERATOXIN (RTX) FOR THE CONTROL OF ELBOW PAIN IN DOGS”

Study Specifics

This is an exploratory study to evaluate the safety and effectiveness of concomitant intra-articular (IA) and peri-neural (PN) injections of an investigational veterinary product for the control of elbow pain in dogs. This 28-day study also includes a long term follow up at 3 and 6 months. This study involves a one-time injectable treatment with investigational product under general anesthesia or sedation. This study does include a control group. An estimated 20 client-owned dogs will be enrolled. Owners will be required to report and record abnormal daily observations and complete questionnaires relating to dog’s pain level throughout the study. Study visits include the dog’s initial consultation, treatment Day 0, recheck visits on Day 7, 28, 90, and 180.


Funding

The study is fully funded for the entire duration of 28 days including the 3 and 6 month follow up visits. Funding includes the initial consultation, the study treatment and administration, recheck visits, and management of side effects that are thought to be directly related to participation in the study.


Eligibility

Dogs are eligible if they meet the following inclusion criteria:

  • In general good health or stabilized for chronic conditions
  • Has body weight of at least 15 kg or higher
  • Has clinically documented articular pain originating in at least one elbow and the only joint on that limb to show signs of pain
  • Has history of persistent lameness due to elbow pain for at least 2 months prior to enrollment
  • Any medication used for the treatment of pain has been discontinued at least 10 days prior to screening
  • In case of bilateral elbow pain, the most clinically affected joint will be selected.

 

Dogs are not eligible if they meet the following exclusion criteria:

  • Dog is < 1 year of age
  • Dog is intended for breeding or is a pregnant or lactating female dog
  • Pain is not related to elbow joint
  • The elbow to be treated is NOT the only joint with pain on that limb
  • The elbow pain is related to intra-articular or peri-articular tumors, recent trauma (less than 2 months), or unhealed fractures (excluding fragmented medial coronoid process)
  • The elbow pain is related to active or actively treated immune mediated joint diseases
  • The dog has undergone medical or surgical procedure that may affect study assessments within 120 days prior to enrollment
  • The dog has medical conditions or has been given medications that may interfere with treatment assessment or anesthesia safety

 

Cornell University Hospital for Animals
930 Campus Rd
Ithaca, NY 14853
(607) 253-3060
vet-research@cornell.edu

Veterinary Specialty Hospital
10435 Sorrento Valley Rd
San Diego, CA 92121
(858) 875-7500
https://vshsd.ethosvet.com/

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.