LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
RELIANCE
Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment
1 other identifier
observational
400
1 country
67
Brief Summary
An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
Typical duration for all trials
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 7, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 4, 2013
April 1, 2013
2.3 years
December 7, 2010
April 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in stool consistency
Stool consistency as measured by the Bristol Stool Form Scale. Change from baseline at Weeks 4 and 12 will be determined.
At Week 4 and Week 12
IBS pain severity
Pain intensity as measured by the 11-point numeric rating scale (NRS) will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined.
At Weeks 4 and 12
Secondary Outcomes (4)
Change from baseline in quality of life scores (IBSQOL).
Week 12
Change from baseline stool frequency.
Week 4 and Week 12
Change from baseline in fecal urgency.
Week 4 and Week 12
Change from baseline in lost productivity.
12 Weeks
Eligibility Criteria
Women ≥ 18 years of age with severe diarrhea-predominant IBS, who have chronic IBS symptoms lasting 6 months or longer and who have not responded adequately to other IBS therapy will be eligible to enroll in the study.
You may qualify if:
- Be a female between 18 and 65 years of age (inclusive) at Visit 1.
- Sign and date a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications.
- Be diagnosed with severe, diarrhea-predominant IBS.
- Have experienced chronic IBS symptoms lasting 6 months or longer.
- Have not responded adequately to other IBS therapy.
- 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.
You may not qualify if:
- Has had a period of 3 consecutive days without a bowel movement in the past 14 days.
- 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.
- Has recurrent bowel obstruction of the small intestine or colon.
- Has had bloody diarrhea or abdominal pain with rectal bleeding in the past 14 days (except rectal bleeding due to hemorrhoids).
- Has a known biochemical or anatomical abnormality of the gastrointestinal tract.
- Has a history of thrombophlebitis or hypercoagulable state.
- Has a history of atherosclerosis.
- 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.)
- Mental impairment of inability to understand the medication guide and instructions for study participation or refusal to comply with protocol.
- Current (within 7 days from start of Lotronex® use) use of fluvoxamine.
- Chronic (≥ 6 months) use of narcotics or opioids.
- The patient has used an investigational drug or participated in an investigational study within 30 days of Visit 1/ Screening Visit.
- The patient is hypersensitive or has a known negative response to 5-HT3 antagonists.
- Had a significant adverse event during previous treatment with Lotronex® or is currently using Lotronex®.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
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 City, 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 City, 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
Related Publications (1)
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.
PMID: 29774051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emil Chuang, MD
Prometheus Therapeutics and Diagnostics
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2010
First Posted
December 9, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 4, 2013
Record last verified: 2013-04