A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH CHRONIC OR REFRACTORY PAIN ASSOCIATED WITH BONE TUMORS DISTAL TO THE ELBOW

April 25th, 2018 Posted by Osteosarcoma 0 thoughts on “A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH CHRONIC OR REFRACTORY PAIN ASSOCIATED WITH BONE TUMORS DISTAL TO THE ELBOW”

Trial Specifics

This trial is designed to evaluate the tolerability, safety and effectiveness of a novel pain management therapy in dogs with chronic or refractory pain associated with bone tumors distal to the elbow. The drug is administered as 2 perineural injections in a single treatment. The injections will be administered under general anesthesia. There is no placebo in this trial. An estimated 12 client-owned dogs with pain associated with bone tumors distal to the elbow will be enrolled at 2 different locations in the U.S. Owners will be required to complete pain assessment surveys and record short at-home videos assessing the dog’s gait. The trial site will train the owners on all of these assessments. Trial visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, 28, and 56. If the dog is receiving bisphosphonates or radiation therapy, a 28-day washout is required prior to enrollment. Other pain medication(s) are accepted so long as the dog has been receiving a consistent regimen for at least 14 days prior to enrollment.

Trial Funding

The trial is fully funded for the full trial duration (56 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not performed within 2 weeks of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to the trial.

Study Eligibility

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

Dogs are eligible if they meet the following inclusion criteria:

  • Owner or owner’s agent has provided written informed consent
  • Dog’s body weight is equal to or greater than 20 kg and less than or equal to 50 kg
  • Investigator has documented cytological or histological diagnosis of primary appendicular bone cancer or strong suspicion of bone cancer based on radiographs, MRI or CT scan
  • Dog’s cancer affects the thoracic limb distal to the elbow with no known metastasis to other bones
  • Dog has a lameness score of 2 or higher as determined by the Investigator


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

  • Dog’s life expectancy less than 2 months
  • Dog has an underlying disease that may, as determined by the Investigator in consultation with the Sponsor and/or medical director, affect the study objectives or patient safety
  • Dog is receiving bisphosphonates or radiation therapy. If dog has received either of these therapies, a 28-day washout is required prior to enrollment. Other pain medication(s) are accepted so long as the dog has been receiving a consistent regimen for at least 14 days prior to enrollment
  • Dog has evidence of a pathological fracture
  • Dog is participating in another study
  • Dog may not be available for the entire study duration
  • Investigator feels the dog or owner is not well suited to the study for another reason

 

This clinical trial is offered at the following locations:

Hope Veterinary Specialists
40 Three Tun Road
Malvern, PA 19355
610-296-2099

Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd.
San Diego, CA 92121

A STOOL SAMPLE COLLECTION STUDY TO DEVELOP A DIAGNOSTIC TOOL FOR DISTINGUISHING GASTROINTESTINAL LYMPHOMA FROM INFLAMMATORY BOWEL DISEASE IN CATS

April 25th, 2018 Posted by Lymphoma, Oncology 0 thoughts on “A STOOL SAMPLE COLLECTION STUDY TO DEVELOP A DIAGNOSTIC TOOL FOR DISTINGUISHING GASTROINTESTINAL LYMPHOMA FROM INFLAMMATORY BOWEL DISEASE IN CATS”

Study Overview

The study seeks to identify 50 cats that have a confirmed diagnosis of IBD or GI lymphoma (endoscopy/colonoscopy, surgery with biopsies or ultrasound guided FNA that confirms large cell lymphoma). Stool samples will then be collected from these cats. Tumor samples may ultimately be collected from cats undergoing surgical biopsies and formalin fixed. All cats that are eligible for the study will require pretreatment stool samples, a demographic sheet that will be filled out by the pet owner determining the age, breed, medications, etc., and a clinical report that will be filled out by the treating veterinarian that provides the disease diagnosis. Logistics associated with collection are as followed:

Study Eligibility

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

Cats are eligible if they meet the following inclusion criteria:

  • Cat has undergone a procedure (endoscopy, colonoscopy, laparotomy or ultrasound-guided FNA) for a diagnosis of IBD or GI lymphoma. FNA will only be accepted for those cats that have a diagnosis of large cell lymphoma
  • Cat has a confirmed diagnosis of IBD or GI lymphoma
  • Owner understands and signs informed consent
  • Stool sample collected prior to treatment for IBD or GI lymphoma


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

  • Cats diagnosed with any other cancer
  • Cats receiving anti-inflammatory or immunosuppressive therapy
  • Cats, that within the last 3 months, have had a positive fecal examination for parasitic, bacterial, or viral infection.


Study Funding

For a cat enrolled in the study to be considered complete, the stool sample and demographic data must be received by Sponsor and the site must have filled-out all clinical data on the online interface. The Sponsor will reimburse the pet owner by mailing him or her a gift card and ACI will reimburse the site for every 5 completed cases or at the end of the study.
This study is offered at the following locations:

Friendship Hospital for Animals
4105 Brandywine St. NW
Washington, DC 20016
202.363.7300

Care Veterinary Center
1080 W. Patrick St.
Frederick, MD 21703
301.662.2273

Veterinary Specialty Hospital – San Diego
10435 Sorrento Valley Rd.
San Diego, CA 92121
868.875.7500

Veterinary Specialty Hospital – North County
2055 Montiel Rd. #104
San Marcos, CA 92069
760.466.0600

Premier Chicago
3927 W. Belmont Ave.
Chicago, IL 60618
773.516.5800

Premier Crestwood
13715 S. Cicero Ave.
Crestwood, IL 60418
708.388.3771

Premier Grayslake
1810 E. Belvidere Rd.
Grayslake, IL 60030
847.548.5300

Boston West Veterinary Emergency and Specialty
5 Strathmore Road
Natick, MA 01760
508.319.2117

The Life Centre
165 Fort Evans Rd NE
Leesburg, VA 20176
703.777.5755

BluePearl – Southfield, MI
29080 Inkster Road
Southfield, MI 48034
248.354.6640

A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH ELBOW DYSPLASIA

January 25th, 2018 Posted by Osteoarthritis 0 thoughts on “A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH ELBOW DYSPLASIA”

Trial Specifics

This trial is designed to evaluate the tolerability, safety and effectiveness of a novel pain management therapy in dogs with elbow dysplasia with osteoarthritis. The drug is administered as one-time intra-articular injections into both elbows in most dogs. A small group of dogs will receive a 2nd treatment 2 weeks after the first injection. The injection will be administered under sedation or general anesthesia. There is no placebo in this trial. An estimated 15 client-owned dogs with will be enrolled. Owners will be required to complete pain assessment surveys, track their dog’s activity through the use of an activity monitor worn on the dog’s collar, and record short at-home videos assessing the dog’s gait. The trial site will train the owners on all of these assessments. Trial visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 14, 28, 56, and 84. Medications targeted at the treatment of osteoarthritis/ elbow dysplasia associated pain are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study.

Trial Funding

The trial is fully funded for the full trial duration (84 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not performed within 4 months of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to the trial.

Trial Eligibility

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

Dogs are eligible if they meet the following inclusion criteria:

  • Dog’s body weight 10-50 kg
  • Dog has clinical signs and radiographic evidence of elbow dysplasia
  • Dog is experiencing elbow-associated pain that is refractory to standard pain management or owner opts for pain management that is distinct from conventional treatments


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

  • Dog has a life expectancy of < 3 months
  • Dog has any underlying disease that will affect the study objectives or patient safety
  • Dog has concurrent or prior immune-mediated or other disease resulting polyarthropathy
  • Dog is impaired due to neurological disease or other orthopedic disease
  • Dog is pregnant or lactating
  • Dog is participating in another study
  • Dog may be unavailable for the entire trial duration or is felt to be unsuitable by the investigator for any other reason
  • Dog requires medications or supplements during the course of the study that interfere with the objectives of the study

 

This clinical trial is offered at the following locations:

Peak Performance Veterinary Group
Dr. James Gaynor
700 Summit Blvd.
Frisco, CO 80443
970-233-0795

Friendship Hospital for Animals
Dr. Mathieu Glassman
4105 Brandywine St. NW
Washington, DC 20016
202-363-7300

Veterinary Specialty and Emergency Center – Conshohocken
625 Ridge Pike, Building B
Conshohocken, PA 19428
484-567-7999

Animal Surgical Clinic of Seattle
14810 15th Ave. NE
Shoreline, WA 98155
206-545-4322

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

Coming Soon

No studies are scheduled at this time.