Open Pain Management Studies

A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL, NERVE BLOCK PAIN MANAGEMENT THERAPY IN DOGS WITH VARYING PAINFUL CONDITIONS

February 7th, 2019 Posted by Pain Management, Pain Studies 0 thoughts on “A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL, NERVE BLOCK PAIN MANAGEMENT THERAPY IN DOGS WITH VARYING PAINFUL CONDITIONS”

Trial Specifics:

This study is designed to evaluate the tolerability, safety and effectiveness of a novel therapy (not yet approved by FDA) to manage various painful conditions in dogs. Examples include bone tumors, chronic orthopedic pain refractory to conventional treatment, and oral tumors. The investigational drug is administered as a peri-nerual injection via a situationally appropriate nerve block. There is no placebo treatment. The one-time treatment will be administered under sedation or general anesthesia to approximately 15 client-owned dogs. Owners are required to complete periodic pain assessment surveys and record short at-home videos assessing their dog’s daily activities. The study staff will train owners on how to complete the assessments. Study visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, 21, 28, and 56. During the course of the study, dogs are permitted to continue other pain medications provided they have been administered for at least 2 weeks prior to enrollment, and are not thought to be continuously improving pain symptoms. If the treated condition is cancer, no new anti-cancer therapy should be administered within 21 days of enrollment.

Trial Funding:

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

Trial Eligibility:

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

Dogs are eligible if they meet the following inclusion criteria:

  • The dog is at least 6 months of age
  • Historical evidence of a localized severe painful condition, reported by owner, but confirmed by the study veterinarian based on a specific pain scale
  • In general, good health or stabilized for chronic conditions as assessed by physical examination, medical history and clinical pathology evaluations
  • Dog is experiencing severe locoregional pain that is refractory to standard pain management or the 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 that is pregnant or lactating
  • Dog has clinical pathology findings considered abnormal and clinically significant that may interfere with the objectives of the study
  • Dog has a condition or requires medications that may interfere with anesthesia safety
  • Dog’s life expectancy is less than 2 months
  • Dog may be unavailable for the entire study duration or is felt to be unsuitable by the investigator for any other reason
  • Dog has acute locoregional pain due to an infection that requires treatment with antibiotics
  • Dog has evidence of a pathological fracture (cancer)
  • Dog is participating in another study
  • Dog that requires medications or supplements that interfere with the objectives of the study including but not limited to TRPV1 agonist or antagonist drug that could interfere with RTX mode of action (such as cannabinoids like CBD and anandamide)

 

NorthStar Vets
Raphael Vezina-Audette, DVM, MSc
315 Robbinsville-Allentown Rd.
Robbinsville, NJ, 08691
Phone: 609-259-8300

FULLY FUNDED CLINICAL STUDY OF A NOVEL THERAPY FOR THE TREATMENT OF MALADAPTIVE PAIN FOLLOWING DECLAW IN CATS

November 27th, 2018 Posted by Chronic Post-Declaw Pain, Pain Management, Pain Studies 0 thoughts on “FULLY FUNDED CLINICAL STUDY OF A NOVEL THERAPY FOR THE TREATMENT OF MALADAPTIVE PAIN FOLLOWING DECLAW IN CATS

Trial Specifics

The purpose of this study is to evaluate the safety and analgesic effect of a novel therapy locally administered by subcutaneous nerve block injection in cats suffering from persistent and localized pain, such as that observed in some cats following onychectomy (declaw). The trial involves a one-time treatment with an investigational product administered via a subcutaneous injection around the nerves responsible the pain sensation in the front paws of declawed cats. The treatment will be administered under sedation or general anesthesia. There is no placebo in this study. An estimated 30 client-owned cats will be enrolled. Owners will be required to complete quality of life and pain surveys during the study (6 of each total). The trial site will train the owners on evaluation techniques. Trial visits include the cats’ initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, and 28. Other medications for declaw-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 and no changes in regimen are expected in the next 4 weeks.

Trial Funding

The trial is fully funded for the full study duration (28 days). Funding includes the initial consultation, the study treatment and administration, recheck visits, required bloodwork, and management of side effects that are thought to be directly related to participation in the study.

Trial 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 localized forelimb pain following onychectomy (declaw) surgery.
  • The cat is experiencing pain that is refractory to pain management or the owner has chosen to pursue pain management that is distinct from conventional treatment.
  • The cat has experienced a significant decrease in quality of life due to refractory pain (i.e., pain and mobility are negatively impacting quality of life).
  • Declaw procedure was performed at least 90 days before the day of RTX treatment.


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 may be unavailable for the entire study duration.
  • The cat is participating in another study.
  • The cat is pregnant or lactating.

 

This clinical trial is offered at the following location:

The Feline Medical Center
Dr. Nicole Martell-Moran
1600 Clear Lake City Blvd,
Suite B
Houston, TX 77062
Email: nicole.martell@nvanet.com
Phone: 281-480-5500

The Pet Doctor, Inc
Marcy Hammerle DVM DABVP
2301 Technology Drive
OFallon, Mo. 63303
Email: Thepetdoctorinc@gmail.com
Phone: 636-561-9122

For more information about future site locations, please contact our Clinical Trial Team: cct@animalci.com

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, Pain Studies 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 effect of a novel therapy in dogs with bladder transitional cell carcinoma (TCC). A secondary goal is to assess potential anti-cancer effect. 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, Pain Studies 0 thoughts on “A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH SEVERE ELBOW DYSPLASIA”

Trial Specifics

This study is designed to evaluate the tolerability, safety and effectiveness of a novel therapy (not yet approved by FDA) to manage pain associated with moderate to severe elbow dysplasia and secondary osteoarthritis in dogs. The investigational drug is administered as an intra-articular injection into both elbows. There is no placebo treatment. The one-time treatment will be administered under sedation or general anesthesia to approximately 28 client-owned dogs. Owners are required to complete periodic pain assessment surveys and record short at-home videos assessing the dog’s gait. The study staff will train owners on how to complete the assessments. The dog’s activity also will be tracked through the use of an activity monitor worn on the dog’s collar. Study 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 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 study is fully funded for its entire duration (approximately 84 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not already performed within 2 weeks of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to study participation.

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

Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd
San Diego, CA 92121
858-875-7500