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

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35406
      • Gastroenterology Consultants Inc.
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Digestive Health Research Unit
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
  • California
    • Beverly Hills, California, United States, 90211
      • Adam D. Karns, MD
    • Irvine, California, United States, 92604
      • Behavioral Research Specialists, LLC
    • Lomita, California, United States, 90717
      • Torrance Clinical Research
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • Redlands, California, United States, 92374
      • Inland Gastroenterology Medical Associates
    • San Carlos, California, United States, 94070
      • Digestive Care Associates
    • San Diego, California, United States, 92103
      • Clinical Applications Laboratories, Inc.
    • San Diego, California, United States, 92115
      • Precision Research Institute, LLC
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves Sleep Disorders & Research Center
    • LaFayette, Colorado, United States, 80026
      • Clinical Research of the Rockies
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Gastroenterology Associates of Fairfield County
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Consultants for Clinical Research of South Florida
    • Coral Gables, Florida, United States, 33134
      • Sanitas Research
    • Deland, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Hollywood, Florida, United States, 33021
      • Southern Clinical Research Consultants
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates, LLC
    • Pensacola, Florida, United States, 32514
      • Gulf Regions Clinical Research Institute
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Tampa, Florida, United States, 33613
      • Bearss Medical
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, PA
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists
    • Chicago, Illinois, United States, 60631
      • GI Solutions
  • Indiana
    • Elwood, Indiana, United States, 46036
      • Investigative Clinical Research of Indiana, LLC
  • Iowa
    • Davenport, Iowa, United States, 52087
      • Gastrointestinal Clinic of Quad Cities
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Louisiana Research Center, LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
  • Michigan
    • Troy, Michigan, United States, 48098
      • Troy Gastroenterology, PC
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan
  • Missouri
    • Mexico, Missouri, United States, 65265
      • Center for Digestive and Liver Diseases, Inc.
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Ocean, New Jersey, United States, 07712
      • Howard Guss, DO
  • New York
    • Brooklyn, New York, United States, 11230
      • Synergy First, LLC
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates
    • Lake Success, New York, United States, 11042
      • New York Center for Clinical Research
    • New York, New York, United States, 10038
      • NY Center for Women's Health Research
    • New York, New York, United States, 10016
      • Concorde Medical Group
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates, PA
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases
    • Harrisburg, North Carolina, United States, 28075
      • Carolinas Research Associates
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Gastroenterology Research Consultants of Greater Cincinnati
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research of Cincinnati
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • Gastroenterology United of Tulsa
  • Oregon
    • Portland, Oregon, United States, 97225
      • The Orgeon Clinic - West Hills Gastroenterology
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • Pennsylvania Research Institute
    • Reading, Pennsylvania, United States, 19606
      • Research Across America
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Anderson Gastroenterology Associates, LLC
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Gastroenterology, PLLC
    • Jackson, Tennessee, United States, 38305
      • HCCA Clinical Research Solutions
    • Murfreesboro, Tennessee, United States, 37129
      • Murfreesboro Medical Clinic
  • Texas
    • Arlington, Texas, United States, 76011
      • Academy of Clinical Research
    • Arlington, Texas, United States, 76015
      • ARAYVAN Clinical Research
    • Austin, Texas, United States, 78756
      • Austin Center for Clinical Research
    • Carrollton, Texas, United States, 75007
      • Trinity Clinical Research
    • Pasadena, Texas, United States, 77505
      • Digestive Health Center
    • Spring, Texas, United States, 77386
      • Spring Gastroenterology
  • Utah
    • West Valley, Utah, United States, 84120
      • Granger Medical Clinic
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
  • Washington
    • Vancouver, Washington, United States, 98686
      • Advanced Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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®.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in quality of life scores (IBSQOL).	Change from baseline in IBSQOL scores will be calculated at Week 12.	Week 12
Change from baseline stool frequency.	Stool frequency will be measured as the mean number of times per day that stools were passed, and will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined	Week 4 and Week 12
Change from baseline in fecal urgency.	Proportion of days with fecal urgency will be calculated for each 4-week interval and change from baseline will be determined at 4 and 12 weeks.	Week 4 and Week 12
Change from baseline in lost productivity.	Lost workplace productivity and number of days IBS symptoms interfered with social/leisure and household activities will be determined at baseline and week 12. Change from baseline to week 12 will be calculated.	12 Weeks

Collaborators and Investigators

• Sponsor: Prometheus Laboratories
• Investigators: Study Director: Emil Chuang, MD, Prometheus Therapeutics and Diagnostics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (ESTIMATE): December 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 1, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Diarrhea; IBS
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 10LOT01