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LiNKA Study Launched In North America Seeks Patients With Hunner’s Lesions

linka001Do you or someone you know suffer from IC with Hunner’s Lesions? If so, you are familiar with the pain that can make it difficult to enjoy life. Allergan, Inc. (http://www.allergan.com/home) is enrolling participants for a research study investigating a drug device to evaluate the safety and effectiveness of a continuous release of lidocaine inserted into the bladder compared with placebo for treating the symptoms of IC with Hunner’s Lesions in female patients. All patients will have the opportunity to receive the active study drug if they request and satisfy the criteria.

Name of Study:

201025-001 – A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females with Interstitial Cystitis with Hunner’s Lesions

Sponsoring Organization: Allergan, Inc.

Who is eligible for the study?

  • Adult female patients with a history of IC with Hunner’s Lesions along with the associated symptoms of IC per AUA guidelines (Hanno et al, 2014).

Who is not eligible for the study?

    • Female patient who is pregnant, nursing, or planning a pregnancy during study participation.

Other criteria apply which will be assessed to determine eligibility of the patients during the screening visit.

Recruitment End Date for IC with Hunner’s Lesion (201025-001): November 2016

Time Commitment: If you qualify for the study, you will have between 16 and 24 clinic or phone study visits. Your participation in the study may last up to 9 months.

Cost to Patient:

  • No-cost study medication
  • No-cost study-related care from a local doctor

LiNKA Study Participating Investigators:

Alabama

Charles White, MD
Coastal Clinical Research, Inc.
100 Memorial Hospital Drive,
Annex Building Suite 3B
Mobile, AL 36608
Study Coordinator: Pam Rowe
(251)414-1984 ext. 125
prowe@ccr-research.com

California

Monisha Crisell, MD
Tri Valley Urology Medical Group
25495 Medical Center Drive Suite 204
Murrietta, CA 92562
Study Coordinator: Anita Deeds
(951) 698-1901 Ext. 232
research@trivalleyurology.com

Gary Leach, MD
Tower Urology
8635 W Third Street
Los Angeles, CA 90048
Study Coordinator: Terry Williams
(310) 854-9898 Ext. 178
williamst@towerurology.com

Edward Levin, MD
Institution: Sutter Health
770 Mason Street
Vacaville, CA 95688
Study Coordinator: Cammy Rieger
Phone: 916-453-5740
riegerc@sutterhealth.org

Connecticut

Jill Peters-Gee, MD
Women’s Health Specialty Care
499 Farmington Avenue, Suite 220
Farmington, CT 06032
Study Coordinator: Madelyn Vasquez
860-678-0365
mvazquez@womenshealthct.com

Georgia

John Miklos, MD
Atlanta Medical Research Institute
3400 Old Milton Pkwy
Building C, Suite 330
Alpharette, GA 30005
Study Coordinator: Melissa Lang
(770) 475-1395
melissa@miklosandmoore.com

Idaho

Joseph Williams, MD
Idaho Urologic Institute
2855 E. Magic View Drive
Meridian, ID 83642
Study Coordinator: Shanna Vail
(208) 639-4900
svail@idurology.com

Indiana

Craig Hanson, MD
Associated Surgeons and Physicians
Women’s Health Advantage
2518 E Dupont Rd
Ft. Wayne, IN 46825
Study Coordinator: Teresa Brousseau
Phone: 260-432-4400 ext 6367
tbrousseau@isapin.com

Illinois

Charles E Miller MD
The Advanced Gynecologic Surgery Institute
120 Osler Dr. Naperville,Il 60540
surgery4women.com
P 630-364-1112
F 847-517-9243
mjohnston@charlesemillermd.org

Maryland

Kent Krejci, MD
Anne Arundel Urology, P.A.
600 Ridgely Avenue, Suite 130
Annapolis, MD 21401
Study Coordinator:   Elizabeth D’Antonio
(410) 266-8049 Ext. 143
ldantonio@aaurology.com

Kannan Mannickam, MD
Chesapeake Urology Research Associates
Renee M. Hammond, LPN, CRC
6820 Hospital Dr., Suite 210
Baltimore, MD 21237
443-471-5749
rhammond@cua.md

Michigan

Roger Beyer, MD
Beyer Research
7110 Stadium Drive
Kalamazoo, MI 49009
Study Coordinator: Lucy Pelletier
Phone: 269-372-7800
lwpelletier@beyerresearch.com

Kenneth Peters, MD
William Beaumont Hospital
3535 West 13 Mile Road, Suite 438
Royal Oak, MI 48073
Study Coordinator: Maureen Cooney
Phone: 248-551-9477
Maureen.cooney@beaumont.edu

New York

Philip Aliotta, MD
Western New York Urology Associates
3085 Harlem Road, Suite 200
Cheektowaga, NY 14225
Study Coordinator: Stephanie Malczewski
(716) 844-5553
smalczewski@wnyurology.com

Alfred Kohan, MD
Urology Institute of Long Island
700 Old Country Road, Suite 101
Plainview, NY 11803
Study Coordinator:  Debra Langone
(516) 433-0049 Ext. 2
dlangone@imppllc.com

Robert Moldwin, MD
The Smith Institute for Urology
North Shore-Long Island Jewish Health System
450 Lakeville Road
Lake Success, New York 11042-1133
Study Coordinator: Monica Johnson
(516) 734-8515

North Carolina

Robert Evans, MD
Wake Forest University Urology Clinic
140 Charlois Blvd
Winston-Salem, NC 27103
Study Coordinator: Janet Shuping
Phone: 336-716-2612
Email: jshuping@wakehealth.edu

Michael Kennelly, MD
McKay Urology
1023 Edgehill Road South
Charlotte, NC 28207
Study Coordinator: Robbin Clark
Robbin.Clark@Carolinashealthcare.org

Jonathan Hamilton, MD
Eastern Urological Associates, PA
275 Bethesda Drive
Greenville, NC 27834
Study Coordinator:   Carla Griffin
(252) 481-0203
cgriffin@easternurological.com

Ohio

Jeffrey Mangel, MD
MetroHealth System
2500 MetroHealth Drive
Rammelkamp Bldg R113
Cleveland, OH 44109
Study Coordinator: Rozina Aamir
Phone: 216-778-8445
Email: raamir@metrohealth.org

Pennsylvania

Kristene Whitmore, MD
Female Sexual and Pelvic Health Institute
207 Broad Street
Philadelphia, PA 19107
(215)863-8100

Washington

Suzette Sutherland, MD
University of Washington Medical Center
1959 NE Pacific Street, Box 356158
1st Floor, SP1266
Seattle, WA 98195
Study Coordinator: Mike Donahue
206-290-8294
mgd@uw.edu

Canada

John Kinahan, MD
Silverado Research Inc
102-1503 Hillside Avenue
Victoria, British Columbia V8T 2C1
Study Coordinator: Amanda Pawlowski
(250) 592-9998
amanda@silveradoresearch.org

By | 2017-01-31T08:40:50+00:00 February 28th, 2016|Clinical Trials, Interstitial Cystitis Network Blog|Comments Off on LiNKA Study Launched In North America Seeks Patients With Hunner’s Lesions

About the Author:

My Google Profile+ Jill Heidi Osborne is the president and founder of the Interstitial Cystitis Network, a health education company dedicated to interstitial cystitis, bladder pain syndrome and other pelvic pain disorders. As the editor and lead author of the ICN and the IC Optimist magazine, Jill is proud of the academic recognition that her website has achieved. The University of London rated the ICN as the top IC website for accuracy, credibility, readability and quality. (Int Urogynecol J - April 2013). Harvard Medical School rated both Medscape and the ICN as the top two websites dedicated to IC. (Urology - Sept 11). Jill currently serves on the Congressionally Directed Medical Research Panel (US Army) where she collaborates with researchers to evaluate new IC research studies for possible funding. Jill has conducted and/or collaborates on a variety of IC research studies on new therapeutics, pain care, sexuality, the use of medical marijuana, menopause and the cost of treatments, shining a light on issues that influence patient quality of life. An IC support group leader and national spokesperson for the past 20 years, she has represented the IC community on radio, TV shows, at medical conferences. She has written hundreds of articles on IC and its related conditions. With a Bachelors Degree in Pharmacology and a Masters in Psychology, Jill was named Presidential Management Intern (aka Fellowship) while in graduate school. (She was unable to earn her PhD due to the onset of her IC.) She spends the majority of her time providing WELLNESS COACHING for patients in need and developing new, internet based educational and support tools for IC patients, including the “Living with IC” video series currently on YouTube and the ICN Food List smartphone app! Jill was diagnosed with IC at the age of 32 but first showed symptoms at the age of 12.