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

April 1, 2013 updated by: Prometheus Laboratories

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in stool consistency
Time Frame: At Week 4 and Week 12
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
Time Frame: At Weeks 4 and 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life scores (IBSQOL).
Time Frame: Week 12
Change from baseline in IBSQOL scores will be calculated at Week 12.
Week 12
Change from baseline stool frequency.
Time Frame: Week 4 and Week 12
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.
Time Frame: Week 4 and Week 12
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.
Time Frame: 12 Weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prometheus Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Emil Chuang, MD, Prometheus Therapeutics and Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10LOT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings