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Center for Comparative and Translational Research Clinical Studies Core College of Veterinary Medicine
The mission of the Clinical Studies Core is to
support interactions between clinical and basic
research groups and to facilitate collaborative
relationships with academic and industrial partners,
practicing veterinarians, and animal owners.
Expanding and Facilitating Translational Opportunities
Clinical Studies CoreClinical Studies Core
InvestigatorInvestigator PAGE 1 F O R M O RE
I N F O R MA T I O N , C O N T A C T : C C M T R C L I N I C A L S T U D I ES C O R E
C C M T R _ C S C @ N C S U . E D U
Janet Bogan
919-515-2633
Lyndy Harden
919-513-6384
November Pet
Health Awareness
Events
National Pet Diabetes Month National Pet Cancer Awareness Month ASPCA Adopt a Senior Pet Month
The translation of basic science discoveries into human clinical patients is fundamental to
the advancement of human health care and disease prevention. However, this translation
is often high risk and is associated with significant costs. Increasingly, researchers are
turning to naturally occurring animal models of human disease processes in which to test
putatively translatable therapies as in intermediate stage prior to testing in human patients.
The fidelity of many naturally occurring animal diseases to human conditions is high, both
in terms of biology and anatomy.
North Carolina State University (NCSU) College of Veterinary Medicine, ranked number 3
globally, houses world-leading expertise in naturally occurring diseases and conditions in
animals. This expertise includes knowledge of diseases and the comparative similarity to
human conditions, expertise in phenotyping and outcome measures and expertise in
specialized surgery and medical disciplines.
The Clinical Studies Core works for: • Sponsors: The CSC works with Sponsors, such as animal health companies, to conduct clinical studies for development of animal health products.
• Investigators: The CSC works with faculty Investigators at the College of Veterinary Medicine to provide expertise, labor, and resources for clinical studies.
• Veterinarians: The CSC works with veterinary practitioners in the region and state to recruit patients and provide opportunities for veterinary professional, clinic, client, and patient participation in clinical studies.
• Patient Owners: The CSC provides information and referral assistance for owners interested in clinical study participation for their pet.
I N S I D E T H I S I S S U E :
NOVEMBER 2013
Featured Clinical Trials 2
Clinical Studies Core
Tip of the Day
2
Clinical Studies Core
Support & Services
3
Volunteer Opportunities 3
Recruiting information for
Current Clinical Trials
4-5
FEATURFEATURED CLINICAL TRIALSED CLINICAL TRIALS
PAGE 2
Clinical Studies Core Tip of the Day:
Be a clinical research ambassador! Conducting clinical research is an essential part of advancing our profession and improving animal health, and is one of our central missions at the CVM. Get to know the available study opportunities, and be willing to share this important mission with your clients.
Regenerative Medicine Approaches to the Treatment of Urinary Incontinence
Purpose:
Urinary incontinence affects more than 20% of spayed female dogs, with medium and large breeds more commonly affected. In the
majority of the cases urinary incontinence is caused by dysfunction of the muscles controlling the urethral sphincter. This results in
uncontrolled loss of urine and can lead to serious bladder and kidney infections, in addition to irritation and/or ulceration of the skin in
contact with the urine. The purpose of this project is to examine the usefulness of cultured muscle cells for the restoration of function
of the urethral sphincter in dogs with naturally occurring urinary incontinence.
Study Design:
Dogs will be evaluated for eligibility by the Internal Medicine Service at the NC State Veterinary Health Complex. Upon your consent,
eligible dogs will have a small muscle biopsy collected; muscle stem cells will be isolated and grown in culture. After the cells have
been grown, they will be injected into the urethral muscle either surgically or cystoscopically while the dog is under general
anesthesia. Dogs will be followed for a period of 24 months to determine the long-term effects of the procedure.
Location:
All initial and follow-up visits will be performed at the NCSU Randall B. Terry, Jr. Companion Animal Veterinary Medical Center.
Eligibility:
Female dogs diagnosed with Urethral Sphincter Mechanism Incompetence (USMI) or “spay incontinence” are eligible to
participate in this study.
Dogs should be in generally good health and have no illnesses that may interfere with the study evaluation.
Dogs newly diagnosed with USMI are eligible to participate, as aredogs already diagnosed and undergoing treatment for USMI.
Study Incentives:
Study visits, anesthesia, biopsy, and stem cell injection (surgical orcystoscopic) will be provided at no cost to the owner.
Contact: NCSU Internal Medicine Service: (919) 513-6670
Dr. Kristen Manning: [email protected] or the CSC:[email protected]
Dogs with Mitral Valve Insufficiency and Heart Failure
Description: The cardiology section is participating in a multicenter clinical trial evaluating a medical therapy for congestive heart failure in dogs. To qualify for the study dogs must have been diagnosed with mitral valvular insufficiency and resultant heart failure (shortness of breath/cough with accompanying radiographic evidence of pulmonary edema). Only dogs which have received medical therapy for congestive heart failure for less than 7 days are eligible for enrollment. Patients will be seen by the NCSU cardiologists at the time of enrollment and again at 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.
Eligibility: minimum body weight of 5.5 lbs
radiographic evidence of pulmonary edema and cardiomegaly (Vertebral Heart Score > 10.5).
left sided murmur consistent with acquired valvular heart disease, grade 3/6 or louder.
treatment for CHF no longer than 7 days prior to enrollment in the study.
The pet can receive furosemide and any other rescue drug for up to 7 pre-enrollment days. After enrollment, oral furosemide, study drug, control drug (a cardiac drug, not placebo) and digoxin and/or diltiazem to control heart rate in atrial fibrillation are the only cardiac drugs that can be used until heart failure recurs and the pet leaves the study.
Financial incentive: The study will cover essentially all cardiac related medical costs (travel, office visits with an NCSU cardiologist, echocardiogram, ECG, radiographs, lab work, blood pressure, and study drug or control) for up to 1 year.
Contact: NCSU Cardiology 919-513-6694
FEATURED CLINICAL TRIALS & VOLUNTEER OPPORTUNITIES PAGE 3
Measurement of Central Sensitization Associated
with Chronic Painful Disease in the Dog
Description: This project aims to determine whether or
not central sensitization occurs in chronically painful
naturally occurring disease. The study will focus on the
dog, and the disease of osteoarthritis. We will develop
techniques to measure central sensitization in vivo, in dogs
with naturally occurring painful disease. From this we will
determine whether or not the quantitative sensory testing
(mechanical, heat, cold) is different between
normal dogs and dogs with osteoarthritis. Later we will be
developing methods to measure nociceptive withdrawal
reflexes and descending noxious inhibitory control.
Eligibility:
Dogs must have decreased mobility in the hind limb
region (stifle and/or hip).
Patients with suspected or confirmed osteoarthritis are
eligible.
Be at least 2 years of age and weigh more than 15 kg
(33 lbs).
Study Incentives:
The study will cover the cost of the physical and
orthopedic examinations, radiographs, serum chemistry
profile, and complete blood count (CBC). No other
financial incentives are offered for participation.
Contact: Dr. David Knazovicky at 919-513-6019
CLINICAL STUDIES CORE
SUPPORT & SERVICES
The CSC provides support for clinical research:
Study preparation including grant, budget, and IACUC
assistance.
Study coordination via patient recruitment, enrollment,
visits, and follow-up.
Data acquisition and management from collection to
quality assurance (QA).
Study monitoring under Good Clinical Practice (GCP)
quality standards.
Technical support through laboratory and clinical
veterinary assistance.
Investigational product management by
randomization, distribution, and disposition.
Resources for Investigators in the design, publicity,
and implementation of clinical studies.
Collaborations with practicing veterinarians, animal
owners, and industry partners. Repository of veterinary tissue samples to support
ongoing and developing studies.
Biospecimen procurement services.
Statistical consulting.
DO YOU HAVE A HEALTHY SPANIEL OR POODLE?
WHY: We are performing a study to compare the daily activity levels of healthy dogs against the activity of dogs
with heart disease.
HOW: Dogs that match our needs will get FREE health
screening to include a physical examination, blood work
(CBC/Chemistry panel/Thyroid test/Urinalysis) and
chest x-rays. Your dog will wear a small activity monitor on their collar for about 15 days and you will be asked to
complete some short questionnaires.
Risk: None
Rewards: Lots of free services (valued ~$300) and help us
finish our study. Also you will get a print out of your
dog’s activity and find out what he/she does when you
are not around!
HERE’S WHO WE NEED:
*Does he/she use stairs regularly?
Contact: Comparative Pain Research Lab,
[email protected], or Clinical Studies Core
[email protected]; 919-513-6384.
BREED AGE RANGE
(years)
WEIGHT
RANGE
(pounds)
USES
STAIRS*
CHILDREN/
OTHER
DOGS
Spaniel 8.6-14.6 18-29 Yes No/no
Poodle/
Poodle mix 10.1-16.1 18-27 Yes Yes/yes
Cavalier
King
Charles
Spaniel
6.2-10.6 21-32 Yes Yes/no
Calling all cats and dogs!
Your dog or cat could help us by participating in a national study investigating
the occurrence of Salmonella infections in pet dogs and cats.
We need stool samples from pet dogs or cats:
with diarrhea; can be presenting complaint or can develop during
hospitalization.
healthy pets, or pets with conditions other than diarrhea.
Eligibility: All cats and dogs are eligible. Only one pet per household may
participate.
Requirements: Culture requires a minimum 1 gram fecal sample.
Sample must be <24 hours collected.
Accepting samples MONDAY-FRIDAY.
Contact: Clinical Studies Core, 919-515-2633
Recruiting Information for Current Clinical TrialsRecruiting Information for Current Clinical TrialsRecruiting Information for Current Clinical Trials
One Medicine
PAGE 4
Effectiveness and safety of Imepitoin in dogs with idiopathic epilepsy.
PI: Dr. Karen Munana
Needs: Presumptive diagnosis of idiopathic epilepsy; < 7 days of prior treatment with anti-seizure medication.
Special considerations: No previous history of seizure clusters or status epilepticus.
Contact: Julie Osborne, [email protected], 919-513-6812
Population pharmacokinetics of ciproflaxin in dogs.
PI: Dr. Mark Papich
Needs: Dogs receiving oral ciproflaxin for at least 24 hours.
Special considerations: Study participants will receive a hospital credit of $50 upon completion of the study.
Contact: Clinical Studies Core,
[email protected], 919-513-6384
Dogs with proteinuric renal disease.
PI: Dr. Shelly Vaden
Needs: Dogs with proteinuric renal disease, urine protein:creatinine ratio >3.0 in
absence of lower urinary tract disease.
Contact: Tonya Harris 919-513-6206, [email protected].
Identification of TCC markers in canine urine.
PI: Dr. Matthew Breen
Needs: Dogs with suspected/confirmed cystitis and dogs with suspected/confirmed TCC or other urogenital cancers.
Contact: Clinical Studies Core, [email protected], 919-513-6384.
Effect of a probiotic on gastrointestinal toxicity in dogs receiving doxorubicin.
PI: Dr. Korinn Saker
Needs: Dogs with cancer diagnosis scheduled to undergo chemotherapy.
Special considerations: Study will cover the cost of oral probiotic, pre-study serum chemistry profile, and 5 days of Cerenia.
Contact: Clinical Studies Core, [email protected], 919-513-6384.
Effect of cranberry extract on myelopathy-associated urinary tract infections.
PI: Dr. Natasha Olby
Needs: Thoracolumbar spinal cord injury due to a disc herniation; treated with decompressive surgery. Contact: Tonya Harris, 919-513-6206, [email protected].
Canine anti-CD20 antibody in combination with CHOP therapy in dogs with untreated B-cell lymphoma.
PI: Dr. Marlene Hauck
Needs: Dogs diagnosed with B-cell lymphosarcoma scheduled to undergo CHOP-based chemotherapy.
Special considerations: Dogs must have at least one lymph node target lesion with a LD of at least 20 mm that can be
measured to assess response to treatment.
Contact: Dr. Marlene Hauck; [email protected]
Evaluation of Bed-side Lung Ultrasound for Emergencies (Vet BLUE) for emergency evaluation of dyspnea in
dogs and cats.
PI: Dr. Jessica Ward
Needs: Dogs and cats presenting with respiratory distress (emergency clinic).
Special considerations: Pet will be stabilized with oxygen and sedation at the discretion of the emergency doctor. Study will
provide a $50 credit toward pet’s visit bill.
Contact: Dr. Jessica Ward; [email protected]; 919-949-0746.
Full Circle
PAGE 5
Recruiting Information for Current Clinical TrialsRecruiting Information for Current Clinical TrialsRecruiting Information for Current Clinical Trials
Genetic evaluation of crystalline corneal dystrophy in Siberian huskies.
PI: Dr. Keith Montgomery
Needs: Ophthalmic exam and DNA samples from affected and unaffected Siberian huskies consistent with a recessive mode
of inheritance.
Special considerations: Recruitment incentive for unaffected subjects (> 8 years of age) includes ophthalmic exam with
slit-lamp biomicroscopy and indirect ophthalmoscopy.
Contact: Dr. Montgomery; [email protected]; 919-515-8117.
Genetic evaluation of canine corneal endothelial dystrophy (CCED) in Boston terriers.
PI: Dr. Keith Montgomery
Needs: Ophthalmic exam and DNA samples from affected and unaffected Boston terriers.
Special considerations: Unaffected dogs > 10 years of age and no known relation to affected dogs.
Contact: Dr. Montgomery; [email protected]; 919-515-8117.
Efficacy and safety of canonized anti-TNF-alpha monoclonal antibody therapy to treat refractory canine atopic
dermatitis in dogs.
PI: Dr. Theirry Olivry
Needs: Dogs with spontaneous nonseasonal (perennial) AD and free of skin and ear infections at the time of enrollment.
Special considerations: Dogs must have demonstrable IgE hypersensitivity to at least one allergen using either
allergen-specific IgE serology or intradermal testing.
Contact: Dr. Olivry; [email protected]; 919-513-7711
Evaluation of pain alleviating effects of NV-01 in dogs with osteoarthritis-associated pain.
PI: Dr. Duncan Lascelles
Needs: Dogs with osteoarthritis in one or more joints for at least 6 months and weighing over 15 kg.
Special considerations: Dogs not on any treatment or dogs that are intolerant of NSAIDS will be preferentially recruited.
Contact: Beth Case; [email protected]; 919-513-6853
Identification of genetic modifiers impacting clinical expression of ARVC in Boxers.
PI: Dr. Kathryn Meurs
Needs: Boxers < 7 years of age; Identify 100 subjects positive heterozygous for the striatin mutation.
Special considerations: Positive subjects will be selected into two groups of 50 each, classified as “low disease expression”
(less than 100 VPC’s/24 hours) and “high disease expression” (at least 500 VPC’s/24 hours).
Contact: Dr. Kathryn Meurs; [email protected]
A randomized controlled trial of the benefit of Royal Canin Anallergenic Veterinary Diet in dogs with
spontaneous pruritic chicken hypersensitivities.
PI: Dr. Petra Bizikova
Needs: Dogs with a history of non-seasonal pruritic skin condition currently controlled with a non-chicken based diet.
Special considerations: Dogs should not be receiving systemic or topical glucocortoids and antihistamines at time of
enrollment (3 weeks wash-out for short-acting oral glucocorticoids; 6 weeks for long-acting injectable glucocorticoids; and
7 days for antihistamines).
Contact: Dr. Petra Bizikova; [email protected]
FOR MORE INFORMATION ON THESE STUDIES VISIT THE CLINICAL STUDIES CORE WEBSITE AT: www.cvm.ncsu.edu/ccmtr/csc-studies.html
