Open Pain Management Studies

SEEKING DOGS FOR ENROLLMENT IN A CLINICAL TRIAL EVALUATING A NOVEL THERAPY FOR THE TREATMENT OF TRANSITIONAL CELL CARCINOMA

October 2nd, 2018 Posted by Bladder Cancer, Pain Management 0 thoughts on “SEEKING DOGS FOR ENROLLMENT IN A CLINICAL TRIAL EVALUATING A NOVEL THERAPY FOR THE TREATMENT OF TRANSITIONAL CELL CARCINOMA”

Trial Specifics

This trial is designed to evaluate the safety and preliminary pain management and anti-cancer effectiveness of a novel therapy in dogs with bladder transitional cell carcinoma (TCC). The trial involves one-time treatment administered directly into the bladder using a urinary catheter. Dogs may receive a second treatment one month after enrollment if warranted. The treatment 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 quality of life surveys, collect a daily urine sample for visual analysis, and record the urine collection results in a provided journal. The trial site will train the owners on collection and evaluation techniques. Trial visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, 28, 56, and 84. Anti-cancer therapies must be discontinued 21 days prior to enrollment. Medications targeted at the treatment of TCC-associated pain, except for CBD and other cannabinoids, 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, thoracic radiographs at the beginning and end of the study, monthly abdominal ultrasounds, recheck visits, trial-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 presenting with a diagnosis of TCC exclusively associated with the bladder (metastasis is acceptable).
  • Dog with accompanying lower urinary tract clinical signs associated with bladder cancer.
  • Bladder lesion does not prevent the passage of urinary catheter.


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

  • Dog with urethral or prostatic involvement of TCC.
  • Dog has any underlying disease that will affect the study objectives or patient safety.
  • Dog has evidence of hydronephrosis.
  • Dog has an active urinary tract infection (dogs presenting for screening will have a urine culture performed prior to enrollment).
  • Dog has a urethral obstruction.
  • Dog is pregnant or lactating.
  • Dog is participating in another study.

 

This clinical trial is offered at the following locations:

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

Las Vegas Veterinary Specialty Center
8650 W. Tropicana Avenue, Ste. B-107
Las Vegas, NV 89147
702-871-1152

BluePearl Specialty and Emergency
11950 West 110th St
Overland Park, KS 66210
913-642-9563

The Oncology Service – Dogwood
5918 West Broad St
Richmond, VA 23230
804-716-4710

The Veterinary Cancer Center
129 Glover Ave, Norwalk
Norwalk, CT 06850
203-838-6626

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

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

Trial Specifics

This trial is designed to evaluate the tolerability, safety and effectiveness of a novel pain management therapy in dogs with severe elbow dysplasia with osteoarthritis. The drug is administered as one-time intra-articular injections into both elbows in most dogs. The injection will be administered under sedation or general anesthesia. There is no placebo in this trial. An estimated 28 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, except for CBD and other cannabinoids, 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 including but not limited to TRPV1 agonist or antagonist drugs that could interfere with RTX mode of action (such as cannabinoids like CBD and anandamide)

 

This clinical trial is offered at the following locations:

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

Veterinary Specialty and Emergency Center
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

Colorado Canine Orthopedics
5528 N. Nevada Ave.
Colorado Springs, CO 80918
719-264-6666

Boston West Veterinary Emergency and Specialty
5 Strathmore Rd
Natick, MA 01760
508-319-2117