Open Pain Management Studies

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.

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.

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.