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Irritable Bowel SyndromeRELIANCENCT01257477

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

An observational study of Irritable Bowel Syndrome, run by Prometheus Laboratories at 67 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Irritable Bowel Syndrome
How many people
400 participants
Where
67 sitesUnited States
Study dates
Nov 2010to Mar 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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®.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Anderson Gastroenterology Associates, LLC

    Anderson, South Carolina, 29621

  • Academy of Clinical Research

    Arlington, Texas, 76011

  • ARAYVAN Clinical Research

    Arlington, Texas, 76015

  • Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists

    Arlington Heights, Illinois, 60005

  • Asheville Gastroenterology Associates, PA

    Asheville, North Carolina, 28801

  • Austin Center for Clinical Research

    Austin, Texas, 78756

  • Pennsylvania Research Institute

    Bensalem, Pennsylvania, 19020

  • Adam D. Karns, MD

    Beverly Hills, California, 90211

  • Consultants for Clinical Research of South Florida

    Boynton Beach, Florida, 33426

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Commonwealth Clinical Studies

    Brockton, Massachusetts, 02302

  • Synergy First, LLC

    Brooklyn, New York, 11230

  • Trinity Clinical Research

    Carrollton, Texas, 75007

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • GI Solutions

    Chicago, Illinois, 60631

  • Consultants for Clinical Research of Cincinnati

    Cincinnati, Ohio, 45219

  • Gastroenterology Research Consultants of Greater Cincinnati

    Cincinnati, Ohio, 45242

  • Delta Waves Sleep Disorders & Research Center

    Colorado Springs, Colorado, 80918

  • Sanitas Research

    Coral Gables, Florida, 33134

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa, 52087

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Investigative Clinical Research of Indiana, LLC

    Elwood, Indiana, 46036

  • Franklin Gastroenterology, PLLC

    Franklin, Tennessee, 37067

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Carolinas Research Associates

    Harrisburg, North Carolina, 28075

  • Southern Clinical Research Consultants

    Hollywood, Florida, 33021

  • Behavioral Research Specialists, LLC

    Irvine, California, 92604

  • HCCA Clinical Research Solutions

    Jackson, Tennessee, 38305

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • Clinical Research of the Rockies

    Lafayette, Colorado, 80026

  • New York Center for Clinical Research

    Lake Success, New York, 11042

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Torrance Clinical Research

    Lomita, California, 90717

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

  • Murfreesboro Medical Clinic

    Murfreesboro, Tennessee, 37129

  • Concorde Medical Group

    New York, New York, 10016

  • NY Center for Women's Health Research

    New York, New York, 10038

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Howard Guss, DO

    Ocean City, New Jersey, 07712

  • Community Clinical Trials

    Orange, California, 92868

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Digestive Health Center

    Pasadena, Texas, 77505

  • Gulf Regions Clinical Research Institute

    Pensacola, Florida, 32514

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • The Orgeon Clinic - West Hills Gastroenterology

    Portland, Oregon, 97225

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Research Across America

    Reading, Pennsylvania, 19606

  • Inland Gastroenterology Medical Associates

    Redlands, California, 92374

  • Digestive Care Associates

    San Carlos, California, 94070

  • Clinical Applications Laboratories, Inc.

    San Diego, California, 92103

  • Precision Research Institute, LLC

    San Diego, California, 92115

  • Digestive Health Research Unit

    Scottsdale, Arizona, 85260

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • Spring Gastroenterology

    Spring, Texas, 77386

  • Bearss Medical

    Tampa, Florida, 33613

  • Troy Gastroenterology, PC

    Troy, Michigan, 48098

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma, 74135

  • Gastroenterology Consultants Inc.

    Tuscaloosa, Alabama, 35406

  • Advanced Gastroenterology

    Vancouver, Washington, 98686

  • Granger Medical Clinic

    West Valley City, Utah, 84120

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

  • Florida Medical Clinic, PA

    Zephyrhills, Florida, 33542

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
Diarrhea, IBS, Irritable Bowel Syndrome
Medical subject headings
Irritable Bowel Syndrome, Diarrhea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 4 and Week 12

  2. 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.

    Measured: At Weeks 4 and 12

Secondary outcomes (4)

  1. Change from baseline in quality of life scores (IBSQOL).

    Change from baseline in IBSQOL scores will be calculated at Week 12.

    Measured: Week 12

  2. 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

    Measured: Week 4 and Week 12

  3. 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.

    Measured: Week 4 and Week 12

  4. 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.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01257477
Sponsor's protocol ID
10LOT01
Acronym
RELIANCE
Status last verified
Apr 2013
First submitted
7 Dec 2010
Last updated
4 Apr 2013
Results posted
No
Data monitoring committee
No

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. Ther Adv Gastroenterol. 2018 May 8;11:1756284818771674. doi: 10.1177/1756284818771674. eCollection 2018.

    PubMed 29774051

Questions about this trial

What is this clinical trial studying?

An observational study of Irritable Bowel Syndrome, run by Prometheus Laboratories at 67 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in stool consistency (time frame: At Week 4 and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01257477, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.

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RELIANCE Clinical Trial NCT01257477 | AzTrials