LOTRONEX� in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Condition(s) targeted: Irritable Bowel Syndrome

Phase: N/A

Status: Recruiting

Sponsored by: Prometheus Laboratories

Official(s) and/or principal investigator(s):
Emil Chuang, MD, Study Director, Affiliation: Prometheus Therapeutics and Diagnostics

Overall contact:
Julio Juarez, Phone: 858-587-4117, Email: julio.juarez@prometheuslabs.com

An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.

Official title: Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment

Study design: Time Perspective: Prospective

Primary outcome:

Change in stool consistency

IBS pain severity

Secondary outcome:

Change from baseline in quality of life scores (IBSQOL).

Change from baseline stool frequency.

Change from baseline in fecal urgency.

Change from baseline in lost productivity.

Detailed description: This observational study will evaluate the effect of Lotronex® as used in the current clinical practice setting on symptom relief, specifically, improvement in bowel habits and IBS pain. Patients planning to initiate commercially available LOTRONEX® therapy will be consented for study participation. Patients will complete study questionnaires related to bowel symptoms, prior therapies, quality of life, productivity loss and treatment outcome. Investigators will also be asked to complete questionnaires related to the patient's disease characteristics, patient progress on study medication and treatment outcome.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

1. Be a female between 18 and 65 years of age (inclusive) at Visit 1.

2. Sign and date a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications.

3. Be diagnosed with severe, diarrhea-predominant IBS.

4. Have experienced chronic IBS symptoms lasting 6 months or longer.

5. Have not responded adequately to other IBS therapy.

6. Be able to read, understand and sign the informed consent and, if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements.

Exclusion Criteria:

1. Has had a period of 3 consecutive days without a bowel movement in the past 14 days.

2. In the past 14 days, has had evidence of chronic or severe constipation, or has a history of chronic or severe constipation, or a history of sequelae from constipation.

3. Has recurrent bowel obstruction of the small intestine or colon.

4. Has had bloody diarrhea or abdominal pain with rectal bleeding in the past 14 days (except rectal bleeding due to hemorrhoids).

5. Has a known biochemical or anatomical abnormality of the gastrointestinal tract.

6. Has a history of thrombophlebitis or hypercoagulable state.

7. Has a history of atherosclerosis.

8. Has any medical or surgical condition that in the judgment of the investigator makes the patient an inappropriate candidate for Lotronex® therapy (e. g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, hematologic, or neurological condition; recent or ongoing malignancy; evidence of hepatic dysfunction; or renal impairment.)

9. Mental impairment of inability to understand the medication guide and instructions for study participation or refusal to comply with protocol.

10. Current (within 7 days from start of Lotronex® use) use of fluvoxamine.

11. Chronic (≥ 6 months) use of narcotics or opioids.

12. The patient has used an investigational drug or participated in an investigational study within 30 days of Visit 1/ Screening Visit.

13. The patient is hypersensitive or has a known negative response to 5-HT3 antagonists.

14. Had a significant adverse event during previous treatment with Lotronex® or is currently using Lotronex®.

Julio Juarez, Phone: 858-587-4117, Email: julio.juarez@prometheuslabs.com

Gastroenterology Consultants Inc., Tuscaloosa, Alabama 35406, United States; Recruiting
Abbey Holthaus, Phone: 205-345-0010, Email: holthaus5@gmail.com
Adisesha Reddy, MD, Principal Investigator

Digestive Health Research Unit, Scottsdale, Arizona 85260, United States; Recruiting
Tricia Duffey, Phone: 480-219-6662, Email: tricia@cdhsaz.com
Nizar Ramzan, MD, Principal Investigator

Lynn Institute of the Ozarks, Little Rock, Arkansas 72205, United States; Recruiting
Kathryn Allen, Phone: 501-975-1966, Email: kallen@lhsi.net
Glenn Davis, MD, Principal Investigator

Adam D. Karns, MD, Beverly Hills, California 90211, United States; Recruiting
Jackie Moreno-Bral, MD, Phone: 323-954-8084, Email: docnhurd@yahoo.com
Adam Karns, MD, Principal Investigator

Behavioral Research Specialists, LLC, Irvine, California 92604, United States; Recruiting
Harry Chung, Phone: 818-524-0000, Email: harrykchung@gmail.com
Samy Younis, MD, Principal Investigator

Torrance Clinical Research, Lomita, California 90717, United States; Recruiting
Mansoreh Afshar, Phone: 310-373-8120, Email: mraikhel@msn.com
Marina Raikhel, MD, Principal Investigator

Community Clinical Trials, Orange, California 92868, United States; Recruiting
Sonia Cummings, Phone: 714-835-1870, Email: cct3@comclintri.com
Craig Ennis, MD, Principal Investigator

Inland Gastroenterology Medical Associates, Redlands, California 92374, United States; Recruiting
Pedro A Bernal, MD CCRC, Phone: 909-796-0363, Email: pedrob@inlandgi.com
Won Jo, MD, Principal Investigator

Digestive Care Associates, San Carlos, California 94070, United States; Recruiting
Colleen Stewart, Phone: 650-596-8800, Email: dcadmin@sbcglobal.net
Scott Levenson, MD, Principal Investigator

Clinical Applications Laboratories, Inc., San Diego, California 92103, United States; Recruiting
Sergio Rodriguez, Phone: 619-260-1012, Email: sergio@calincresearch.com
Vijaya Pratha, MD, Principal Investigator

Precision Research Institute, LLC, San Diego, California 92115, United States; Recruiting
Tamara Packard, Phone: 619-266-3332, Email: tamara@prisandiego.com
Taddese Desta, M.D., Principal Investigator

Delta Waves Sleep Disorders & Research Center, Colorado Springs, Colorado 80918, United States; Recruiting
Val Davis, Phone: 719-262-9283, Email: val@deltawaves.org
Kent Roberson, MD, Principal Investigator

Clinical Research of the Rockies, LaFayette, Colorado 80026, United States; Recruiting
Diana Beckner, Phone: 303-604-5000, Email: diana.beckner@gastrorockies.com
David Gatof, MD, Principal Investigator

Gastroenterology Associates of Fairfield County, Bridgeport, Connecticut 06606, United States; Recruiting
Janet Kusick, Phone: 203-333-3328, Email: jkusick@gidox.com
Strick Woods, MD, Principal Investigator

Consultants for Clinical Research of South Florida, Boynton Beach, Florida 33426, United States; Recruiting
MaryLu Sullivan-Wells, Phone: 561-732-9722, Email: mwells@ccrstudy.com
Madeleine Dupree, MD, Principal Investigator

Sanitas Research, Coral Gables, Florida 33134, United States; Recruiting
William Cisneros, Phone: 800-844-1824, Email: william@sanitas-research.com
Rogelio Bardinas- Rodriguez, MD, Principal Investigator

Avail Clinical Research, LLC, Deland, Florida 32720, United States; Recruiting
Donna Flowers, Phone: 386-740-0770, Email: dflowers@availclinical.com
John Hill, MD, Principal Investigator

Southern Clinical Research Consultants, Hollywood, Florida 33021, United States; Recruiting
Aileen Kirziver, Phone: 954-985-0019, Email: akirzner@gastro-consults.com
Wayne Schonfeld, MD, Principal Investigator

Borland-Groover Clinic, Jacksonville, Florida 32256, United States; Recruiting
Jackie Hazelip, Phone: 904-680-0871, Email: jhazelip@bgclinic.com
Joseph Bradford, MD, Principal Investigator

Advanced Gastroenterology Associates, LLC, Palm Harbor, Florida 34684, United States; Recruiting
Joanne Root, Phone: 727-786-0017, Email: research@advancedgastro.com
Jawajar Taunk, MD, Principal Investigator

Gulf Regions Clinical Research Institute, Pensacola, Florida 32514, United States; Recruiting
Jamie Mattina, Phone: 850-969-2561, Email: jamie.mattina@medicalcenterclinic.com
Ronald Powell, M.D., Principal Investigator

Accord Clinical Research, LLC, Port Orange, Florida 32129, United States; Recruiting
Lori LaChapelle, Phone: 386-760-3862, Email: llachapelle@accordclinical.com
Donato Ricci, MD, Principal Investigator

Bearss Medical, Tampa, Florida 33613, United States; Recruiting
Olayemi Claridge, Phone: 813-977-7804, Email: yemic.jcr@gmail.com
Eugene Ward, MD, Principal Investigator

Florida Medical Clinic, PA, Zephyrhills, Florida 33542, United States; Recruiting
Sandi Ellis, Phone: 813-780-8368, Email: sellis@floridamedicalclinic.com
Tawfik Chami, Principal Investigator

Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists, Arlington Heights, Illinois 60005, United States; Recruiting
Sandy Gochnour, Phone: 847-439-1005, Email: sgochnour@northwestgastro.com
Laura Boskey, Phone: 847-439-1005
David Sales, MD, Principal Investigator

GI Solutions, Chicago, Illinois 60631, United States; Recruiting
Joseph Simi, Phone: 773-631-2728, Email: sjesto@gisolutioninc.com
Arun Ohri, MD, Principal Investigator

Investigative Clinical Research of Indiana, LLC, Elwood, Indiana 46036, United States; Recruiting
Leslie Weitman, Phone: 317-297-2208, Email: leslieweitman@sbcglobal.net
Robert Helm, MD, Principal Investigator

Gastrointestinal Clinic of Quad Cities, Davenport, Iowa 52087, United States; Recruiting
Yvonne Bonick, Phone: 563-359-9696, Email: clinicalphasesinc@hotmail.com
Bettaiah Gowda, MD, Principal Investigator

Louisiana Research Center, LLC, Shreveport, Louisiana 71103, United States; Recruiting
Debbie Hatfield, Phone: 318-525-3233, Email: dhatfield@gis.md
Humberto Aguilar, MD, Principal Investigator

Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States; Recruiting
Susana Hernandez, Phone: 301-652-5520, Email: suzy.hernandez@capitaldigestivecare.com
Robert Hardi, MD, Principal Investigator

Meritus Center for Clinical Research, Hagerstown, Maryland 21742, United States; Recruiting
Angela Angstadt, Phone: 301-665-4608, Email: Angela.Angstadt@meritushealth.com
Juan Tayler, MD, Principal Investigator

Commonwealth Clinical Studies, Brockton, Massachusetts 02302, United States; Recruiting
Beth Olson, Phone: 508-588-6700, Email: bolson@gisdoc.com
Jerry Stern, MD, Principal Investigator

Troy Gastroenterology, PC, Troy, Michigan 48098, United States; Recruiting
Dawn Gedvilas, Phone: 248-267-8489, Email: dgedvilas@troygastro.com
John Weber, MD, Principal Investigator

Gastroenterology Associates of Western Michigan, Wyoming, Michigan 49519, United States; Recruiting
Jodi Mcpherson, Phone: 616-328-5335, Email: jhost@gastro-assoc-wm.com
Allan Coates, DO, Principal Investigator

Center for Digestive and Liver Diseases, Inc., Mexico, Missouri 65265, United States; Recruiting
Nick Steiner, Phone: 573-581-7196, Email: Nick.Steiner@gutdoc.us
Glenn Gordon, MD, Principal Investigator

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Barbara Hewitt, Phone: 603-653-3651, Email: Barbara.A.Hewitt@Hitchcock.ORG
Brian Lacy, MD, Principal Investigator

Howard Guss, DO, Ocean, New Jersey 07712, United States; Recruiting
Karen Norek, Phone: 732-775-9000, Email: cardiokar19@aol.com
Guss Howard, DO, Principal Investigator

Synergy First, LLC, Brooklyn, New York 11230, United States; Recruiting
Mordecai Erps, Phone: 718-339-7500, Email: merps@synergyfirstmed.com
Jeffrey Ben-Zvi, MD, Principal Investigator

Long Island Clinical Research Associates, Great Neck, New York 11021, United States; Recruiting
Kuntal Shastri, Phone: 516-466-1051, Email: kuntal.shastri@yahoo.com
Lev Ginzburg, MD, Principal Investigator

New York Center for Clinical Research, Lake Success, New York 11042, United States; Recruiting
Margaritte DeFalco, Phone: 516-326-2700, Email: nyccrnurse@aol.com
David Eskreis, MD, Principal Investigator

Concorde Medical Group, New York, New York 10016, United States; Recruiting
Juanita Jones, Phone: 212-889-5544, Email: jjones@concordemed.com
Jonathan Cohen, MD, Principal Investigator

NY Center for Women's Health Research, New York, New York 10038, United States; Recruiting
Ruby Wu, Phone: 646-290-9560, Email: ruby@pelvicpainnewyork.com
Kenneth Levey, MD, Principal Investigator

Asheville Gastroenterology Associates, PA, Asheville, North Carolina 28801, United States; Recruiting
Roberta Golden, Phone: 828-254-0881, Email: Roberta.golden@ashevillegastro.com
Thea Mueller, Phone: 828-254-0881
Kisha Weiser, MD, Principal Investigator

Carolina Digestive Diseases, Greenville, North Carolina 27834, United States; Recruiting
Katrina Strickland, Phone: 252-758-8181, Email: katrina.strickland@yahoo.com
Stefano Marcuard, MD, Principal Investigator

Carolinas Research Associates, Harrisburg, North Carolina 28075, United States; Recruiting
Jenny Norton, Phone: 704-996-0934, Email: jnorton@carolinasresearch.com
Fred Fowler, MD, Principal Investigator

Wake Research Associates, Raleigh, North Carolina 27612, United States; Recruiting
Brent Woolard, Phone: 919-781-2514, Email: twoolard@wakeresearch.com
Charles Barish, MD, Sub-Investigator

Consultants for Clinical Research of Cincinnati, Cincinnati, Ohio 45219, United States; Recruiting
Connie McNanie, Phone: 513-872-4549, Email: cmcnanie@ccrstudy.com
Michael Safdi, MD, Principal Investigator

Gastroenterology Research Consultants of Greater Cincinnati, Cincinnati, Ohio 45242, United States; Recruiting
Vivian Bawtenheimer, Phone: 513-794-5656, Email: research@giconsults.com
Maritza Palusiak, MD, Principal Investigator

Great Lakes Gastroenterology, Mentor, Ohio 44060, United States; Recruiting
Judy Holmes, Phone: 440-205-1225, Email: glgresearch@hotmail.com
Keith Friedenberg, MD, Principal Investigator

Gastroenterology United of Tulsa, Tulsa, Oklahoma 74135, United States; Recruiting
Lela Brewer, Phone: 918-749-3399, Email: Lela@DrGut.com
David James, DO, Principal Investigator

The Orgeon Clinic - West Hills Gastroenterology, Portland, Oregon 97225, United States; Recruiting
Sara Parton, Phone: 503-292-6452, Email: sparton@orclinic.com
David Grunkemeier, MD, Principal Investigator

Pennsylvania Research Institute, Bensalem, Pennsylvania 19020, United States; Recruiting
Carole Brown, Phone: 817-470-4212, Email: carole-brown@comcast.net
Stevan Smallow, M.D., Principal Investigator

Research Across America, Reading, Pennsylvania 19606, United States; Recruiting
Jolene Sponhewer, Phone: 610-779-7061, Email: JSponhower@researchacrossamerica.com
Maxine Beaner, Phone: 610-779-7061, Email: mbeaner@researchacrossamerica.com
Michael Warren, MD, Principal Investigator

Anderson Gastroenterology Associates, LLC, Anderson, South Carolina 29621, United States; Recruiting
Allison McClellan, Phone: 864-225-7401, Email: amcclellan34@bellsouth.com
Charles Scowcroft, MD, Principal Investigator

Franklin Gastroenterology, PLLC, Franklin, Tennessee 37067, United States; Recruiting
Monica Strawther, Phone: 615-771-8786, Email: fgi.researchsc@gmail.com
Wilmot Burch, MD, Principal Investigator

HCCA Clinical Research Solutions, Jackson, Tennessee 38305, United States; Recruiting
Vickie Grisby, Phone: 731-431-5027, Email: vgrigsby@hccacrs.com
Bob Souder, MD, Principal Investigator

Murfreesboro Medical Clinic, Murfreesboro, Tennessee 37129, United States; Recruiting
Kimberly Dymond, PA-C, Phone: 615-867-8070, Email: kdymond@mmclinic.com
Kimberly Dymond, PA-C, Principal Investigator

Academy of Clinical Research, Arlington, Texas 76011, United States; Recruiting
Umer Hafeez, Phone: 817-470-4212, Email: aocrdoctors@gmail.com
Robert Kent, M.D., Principal Investigator

ARAYVAN Clinical Research, Arlington, Texas 76015, United States; Recruiting
Adina Williams, Phone: 817-375-1560, Email: adina.williams@arayvan.com
Marc Wilson, MD, Principal Investigator

Austin Center for Clinical Research, Austin, Texas 78756, United States; Recruiting
Joaquin Sosa, Phone: 512-537-4201, Email: jsosa.accr@gmail.com
Aziz Laurent, MD, Principal Investigator

Trinity Clinical Research, Carrollton, Texas 75007, United States; Recruiting
Rimla Joseph, Phone: 214-793-8341, Email: rimla.joseph@yahoo.com
Farida Valliani, MD, Principal Investigator

Digestive Health Center, Pasadena, Texas 77505, United States; Recruiting
Kim Brown, Phone: 713-946-9513, Ext: 225, Email: kim.brown@digestivehealth.cc
Julie Lynn Erps, PA-C, Principal Investigator

Spring Gastroenterology, Spring, Texas 77386, United States; Recruiting
Aijaz Hussain, Phone: 281-302-5193, Email: ahussain@springclinicalresearch.com
Ravi Moparty, M.D., Principal Investigator

Granger Medical Clinic, West Valley, Utah 84120, United States; Recruiting
Kim Beaulieu, Phone: 801-965-3670, Email: cbriscoe@grangermedical.com
Deb Plasman, PA-C, Principal Investigator

Gastroenterology Associates of Tidewater, Chesapeake, Virginia 23320, United States; Recruiting
Crystal Beaber, Phone: 757-842-6009, Email: cbeaber@gatgi.com
Pramod Malik, MD, Principal Investigator

Digestive and Liver Disease Specialists, Norfolk, Virginia 23502, United States; Recruiting
Pamela Hoisington, Phone: 757-466-0165, Email: pamelah@dlds.org
Whitney Brooks, MD, Principal Investigator

Advanced Gastroenterology, Vancouver, Washington 98686, United States; Recruiting
Courtney Scott, Phone: 360-576-5060, Email: cscott@agipractice.com
Son Do, MD, Principal Investigator

Starting date: November 2010
Last updated: October 3, 2012