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.