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

Condition(s) targeted: Irritable Bowel Syndrome

Phase: N/A

Status: Completed

Sponsored by: Prometheus Laboratories

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

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®.

Gastroenterology Consultants Inc., Tuscaloosa, Alabama 35406, United States

Digestive Health Research Unit, Scottsdale, Arizona 85260, United States

Lynn Institute of the Ozarks, Little Rock, Arkansas 72205, United States

Adam D. Karns, MD, Beverly Hills, California 90211, United States

Behavioral Research Specialists, LLC, Irvine, California 92604, United States

Torrance Clinical Research, Lomita, California 90717, United States

Community Clinical Trials, Orange, California 92868, United States

Inland Gastroenterology Medical Associates, Redlands, California 92374, United States

Digestive Care Associates, San Carlos, California 94070, United States

Clinical Applications Laboratories, Inc., San Diego, California 92103, United States

Precision Research Institute, LLC, San Diego, California 92115, United States

Delta Waves Sleep Disorders & Research Center, Colorado Springs, Colorado 80918, United States

Clinical Research of the Rockies, LaFayette, Colorado 80026, United States

Gastroenterology Associates of Fairfield County, Bridgeport, Connecticut 06606, United States

Consultants for Clinical Research of South Florida, Boynton Beach, Florida 33426, United States

Sanitas Research, Coral Gables, Florida 33134, United States

Avail Clinical Research, LLC, Deland, Florida 32720, United States

Southern Clinical Research Consultants, Hollywood, Florida 33021, United States

Borland-Groover Clinic, Jacksonville, Florida 32256, United States

Advanced Gastroenterology Associates, LLC, Palm Harbor, Florida 34684, United States

Gulf Regions Clinical Research Institute, Pensacola, Florida 32514, United States

Accord Clinical Research, LLC, Port Orange, Florida 32129, United States

Bearss Medical, Tampa, Florida 33613, United States

Florida Medical Clinic, PA, Zephyrhills, Florida 33542, United States

Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists, Arlington Heights, Illinois 60005, United States

GI Solutions, Chicago, Illinois 60631, United States

Investigative Clinical Research of Indiana, LLC, Elwood, Indiana 46036, United States

Gastrointestinal Clinic of Quad Cities, Davenport, Iowa 52087, United States

Louisiana Research Center, LLC, Shreveport, Louisiana 71103, United States

Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States

Meritus Center for Clinical Research, Hagerstown, Maryland 21742, United States

Commonwealth Clinical Studies, Brockton, Massachusetts 02302, United States

Troy Gastroenterology, PC, Troy, Michigan 48098, United States

Gastroenterology Associates of Western Michigan, Wyoming, Michigan 49519, United States

Center for Digestive and Liver Diseases, Inc., Mexico, Missouri 65265, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Howard Guss, DO, Ocean, New Jersey 07712, United States

Synergy First, LLC, Brooklyn, New York 11230, United States

Long Island Clinical Research Associates, Great Neck, New York 11021, United States

New York Center for Clinical Research, Lake Success, New York 11042, United States

Concorde Medical Group, New York, New York 10016, United States

NY Center for Women's Health Research, New York, New York 10038, United States

Asheville Gastroenterology Associates, PA, Asheville, North Carolina 28801, United States

Carolina Digestive Diseases, Greenville, North Carolina 27834, United States

Carolinas Research Associates, Harrisburg, North Carolina 28075, United States

Wake Research Associates, Raleigh, North Carolina 27612, United States

Consultants for Clinical Research of Cincinnati, Cincinnati, Ohio 45219, United States

Gastroenterology Research Consultants of Greater Cincinnati, Cincinnati, Ohio 45242, United States

Great Lakes Gastroenterology, Mentor, Ohio 44060, United States

Gastroenterology United of Tulsa, Tulsa, Oklahoma 74135, United States

The Orgeon Clinic - West Hills Gastroenterology, Portland, Oregon 97225, United States

Pennsylvania Research Institute, Bensalem, Pennsylvania 19020, United States

Research Across America, Reading, Pennsylvania 19606, United States

Anderson Gastroenterology Associates, LLC, Anderson, South Carolina 29621, United States

Franklin Gastroenterology, PLLC, Franklin, Tennessee 37067, United States

HCCA Clinical Research Solutions, Jackson, Tennessee 38305, United States

Murfreesboro Medical Clinic, Murfreesboro, Tennessee 37129, United States

Academy of Clinical Research, Arlington, Texas 76011, United States

ARAYVAN Clinical Research, Arlington, Texas 76015, United States

Austin Center for Clinical Research, Austin, Texas 78756, United States

Trinity Clinical Research, Carrollton, Texas 75007, United States

Digestive Health Center, Pasadena, Texas 77505, United States

Spring Gastroenterology, Spring, Texas 77386, United States

Granger Medical Clinic, West Valley, Utah 84120, United States

Gastroenterology Associates of Tidewater, Chesapeake, Virginia 23320, United States

Digestive and Liver Disease Specialists, Norfolk, Virginia 23502, United States

Advanced Gastroenterology, Vancouver, Washington 98686, United States

Starting date: November 2010
Last updated: April 1, 2013