LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
NCT ID: NCT01257477
Last Updated: 2013-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2010-11-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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®.
18 Years
65 Years
FEMALE
No
Sponsors
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Prometheus Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Emil Chuang, MD
Role: STUDY_DIRECTOR
Prometheus Therapeutics and Diagnostics
Locations
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Gastroenterology Consultants Inc.
Tuscaloosa, Alabama, United States
Digestive Health Research Unit
Scottsdale, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Adam D. Karns, MD
Beverly Hills, California, United States
Behavioral Research Specialists, LLC
Irvine, California, United States
Torrance Clinical Research
Lomita, California, United States
Community Clinical Trials
Orange, California, United States
Inland Gastroenterology Medical Associates
Redlands, California, United States
Digestive Care Associates
San Carlos, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
Precision Research Institute, LLC
San Diego, California, United States
Delta Waves Sleep Disorders & Research Center
Colorado Springs, Colorado, United States
Clinical Research of the Rockies
Lafayette, Colorado, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, United States
Sanitas Research
Coral Gables, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Southern Clinical Research Consultants
Hollywood, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Gulf Regions Clinical Research Institute
Pensacola, Florida, United States
Accord Clinical Research, LLC
Port Orange, Florida, United States
Bearss Medical
Tampa, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists
Arlington Heights, Illinois, United States
GI Solutions
Chicago, Illinois, United States
Investigative Clinical Research of Indiana, LLC
Elwood, Indiana, United States
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Troy Gastroenterology, PC
Troy, Michigan, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, United States
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Howard Guss, DO
Ocean City, New Jersey, United States
Synergy First, LLC
Brooklyn, New York, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
New York Center for Clinical Research
Lake Success, New York, United States
Concorde Medical Group
New York, New York, United States
NY Center for Women's Health Research
New York, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Carolina Digestive Diseases
Greenville, North Carolina, United States
Carolinas Research Associates
Harrisburg, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Consultants for Clinical Research of Cincinnati
Cincinnati, Ohio, United States
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, United States
The Orgeon Clinic - West Hills Gastroenterology
Portland, Oregon, United States
Pennsylvania Research Institute
Bensalem, Pennsylvania, United States
Research Across America
Reading, Pennsylvania, United States
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, United States
Franklin Gastroenterology, PLLC
Franklin, Tennessee, United States
HCCA Clinical Research Solutions
Jackson, Tennessee, United States
Murfreesboro Medical Clinic
Murfreesboro, Tennessee, United States
Academy of Clinical Research
Arlington, Texas, United States
ARAYVAN Clinical Research
Arlington, Texas, United States
Austin Center for Clinical Research
Austin, Texas, United States
Trinity Clinical Research
Carrollton, Texas, United States
Digestive Health Center
Pasadena, Texas, United States
Spring Gastroenterology
Spring, Texas, United States
Granger Medical Clinic
West Valley City, Utah, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Advanced Gastroenterology
Vancouver, Washington, United States
Countries
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References
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Lacy BE, Nicandro JP, Chuang E, Earnest DL. Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint. Therap Adv Gastroenterol. 2018 May 8;11:1756284818771674. doi: 10.1177/1756284818771674. eCollection 2018.
Other Identifiers
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10LOT01
Identifier Type: -
Identifier Source: org_study_id
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