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Irritable Bowel Syndrome With DiarrheaPhase 4NCT02959983

Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

A Phase 4 study testing Eluxadoline in people with Irritable Bowel Syndrome With Diarrhea, run by Allergan at 83 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D symptoms. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
Eluxadoline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
346 participants
Where
83 sitesin 2 countries
Study dates
25 Oct 2016to 22 Jan 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a diagnosis of IBS-D, defined by the Rome III criteria as loose (mushy) or watery stools ≥25% and hard or lumpy stools ≤25% of bowel movements.
  • Has had a colonoscopy performed within 5 years prior to Screening if they are at least 50 years of age, OR if they meet any of the following alarm features:
  • Has documented weight loss within the past 6 months; or
  • Has nocturnal symptoms; or
  • Has a familial history of colon cancer; or
  • Has blood mixed with their stool (excluding any blood from hemorrhoids)
  • Patient reports use of loperamide in the 12 months prior to Screening for IBS-D symptoms and that loperamide did not provide adequate control of IBS-D symptoms.
  • Has not used any loperamide rescue medication within 14 days prior to randomization.

Who cannot join

  • Has a diagnosis of Irritable Bowel Syndrome (IBS) with a subtype of constipation IBS, mixed IBS, or unsubtyped IBS.
  • Has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), microscopic colitis, or celiac disease.
  • Has a history of diverticulitis within 3 months prior to screening.
  • Has a documented history of lactose intolerance.
  • Has a documented history of bile-acid malabsorption.
  • Has a history of chronic or severe constipation or intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions.
Show all 25Show fewer
  • Has any of the following surgical history:
  • Cholecystectomy or previously documented agenesis of gallbladder; or
  • Any abdominal surgery within the 3 months prior to screening; or
  • Major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
  • Has a history of cholecystitis within 6 months before screening.
  • Has a history of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
  • Has a history of known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction, excluding a history of gallstones.
  • Has a history or current evidence of laxative abuse within 5 years prior to screening.
  • Has documented evidence of cirrhosis.
  • Has a history of cardiovascular events, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to screening.
  • Has an unstable renal, hepatic, metabolic, or hematologic condition.
  • Has a history of malignancy within 5 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
  • Has a history of human immunodeficiency virus infection.
  • Has a history of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision-defined substance dependency, excluding nicotine and caffeine, within 2 years prior to screening.
  • Has a history of alcohol abuse, alcohol addiction, and alcoholism or drinks more than 3 alcoholic beverages per day.
  • Has used aspirin or aspirin-containing medications (>325 mg of aspirin per day) or nonsteroidal anti-inflammatory drugs, when taken specifically for the symptoms of IBS, within 14 days of randomization.
  • Has current (within 14 days of randomization) or expected use of any narcotic or opioid-containing agents, tramadol, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents [except loperamide rescue medication after randomization]), antinausea agents, antispasmodic agents, bismuth, or prokinetic agents.
  • Has current (within 28 days of randomization) use of rifaximin or other antibiotics (with the exception of topical antibiotics or a 1-day course with an antibiotic). Expected use of rifaximin or other antibiotics during the course of the study that is known at the time of randomization.
  • Has an elective surgery planned or expects to need elective surgery at any time during the study.

Trial locations and contacts

83 sites in 2 countries.

83 sites in 2 countries

United States76 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Premier Family Physicians

    Austin, Texas, 78735

  • Clinical Inquest Center Ltd

    Beavercreek, Ohio, 45431

  • The Center for Clinical Trials

    Biloxi, Mississippi, 39531

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • Drug Trials Brooklyn

    Brooklyn, New York, 11230

  • NY Scientific

    Brooklyn, New York, 11235

  • Investigators Research

    Brownsburg, Indiana, 46112

  • RNA America, LLC

    Buford, Georgia, 30518

  • Med Investigations

    Carmichael, California, 95608

  • Family Medicine Associate of Texas

    Carrollton, Texas, 75010

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Insititute of Michigan LLC

    Chesterfield, Michigan, 48047

  • MGG Group Co. Inc. Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Northwestern University Feinbery School of Medicine

    Chicago, Illinois, 606611

  • GW Research Inc

    Chula Vista, California, 91910

  • Hometown Urgent Care and Research

    Cincinnati, Ohio, 45215

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Buckeye Health and Research

    Columbus, Ohio, 43207

  • Hometown Urgent Care and Research

    Columbus, Ohio, 43214

  • Digestive Care of N. Broward

    Coral Springs, Florida, 33065

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Diagnamics Inc

    Encinitas, California, 92024

  • Radiant Research, Inc.

    Evansville, Indiana, 47714

  • Clinical Research Advantage Inc/Radiant Research Inc.

    Evansville, Indiana, 47725

  • Pharmakon Inc

    Evergreen Park, Illinois, 60805

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Long Island Gastrointestinal Group LLP

    Great Neck, New York, 11023

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Peters Medical Research LLC

    High Point, North Carolina, 27265

  • Homestead Medical Research

    Homestead, Florida, 33030

  • Hometown Urgent Care and Research

    Huber Heights, Ohio, 45424

  • Clinical Research Associates, LLC

    Huntsville, Alabama, 35801

  • Behavioral Research Specialists, LLC

    Irvine, California, 92606

  • Clinical Neuroscience Solutions Inc.

    Jacksonville, Florida, 32256

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • IMA Medical Research, PC

    Kew Gardens, New York, 11415

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Precision Clinical Research LLC

    Lauderdale Lakes, Florida, 33319

  • North State Clincial Research PLLC

    Lenoir, North Carolina, 28645

  • Women's Clinic of Lincoln, P.C.

    Lincoln, Nebraska, 68510

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • Pharmax Research Clinic Inc.

    Miami, Florida, 33126

  • Well Pharma Medical Research, Corp.

    Miami, Florida, 33143

  • Ocean Blue Medical Research Center, Inc

    Miami Springs, Florida, 33166

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Bravo Health Care Center

    North Bay Village, Florida, 33141

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Advanced Research Institute - Ogden

    Ogden, Utah, 84405

  • Quality Clinical Research Inc.

    Omaha, Nebraska, 68114

  • Clinical Neuroscience Solutions Inc.

    Orlando, Florida, 32801

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Wake Research Associates LLC

    Raleigh, North Carolina, 27612

  • Advanced Research Institute

    Reno, Nevada, 89511

  • The Oregon Center for Clinical Investigations, INC.

    Salem, Oregon, 97301

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Multi-Phase Trials LLC

    San Antonio, Texas, 78217

  • Health Texas Research Institute

    San Antonio, Texas, 78228

  • Discovery Clinical Trials - Stone Oak

    San Antonio, Texas, 78258

  • The Center for Clinical Trials

    Saraland, Alabama, 36571

  • Gtc Research

    Shawnee Mission, Kansas, 66218

  • Shahram Jacobs MD INC.

    Sherman Oaks, California, 91403

  • Carl Meisner Medical Clinic

    Sugar Land, Texas, 77478

  • Clinical Research of West Florida Inc.

    Tampa, Florida, 33603

  • Meridien Research

    Tampa, Florida, 33634

  • Westlake Medical Research

    Thousand Oaks, California, 91360

  • Upland Clinical Research

    Upland, California, 91786

  • MedVadis Research Corporation

    Watertown, Massachusetts, 02472

  • Advanced RX Clinicial Research Group, Inc.

    Westminster, California, 92683

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan, 49519

Other trials in United States

Canada7 sites

  • University of Calgary

    Calgary, T2N 1N4

  • Corunna Medical Research Centre

    Corunna, Ontario, N0N 1G0

  • Manna Research

    Etobicoke, Ontario, 7LM 4Y1

  • SKDS Research Inc

    Newmarket, Ontario, L3Y 5G8

  • Viable Clinical Research Corp.

    Nova Scotia, B4V 3N2

  • Centre de reserche St Louis

    Québec, G1W4R4

  • Dynamik Research Inc

    Québec, H9R 3J1

Other trials in Canada

About this study

Official title: A Phase 4 Multicenter, Multinational, Prospective, Randomized, Placebo-Controlled, Double-Blinded Parallel Group Study to Assess Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) in Patients Who Report Inadequate Control of IBS-D Symptoms With Prior Loperamide Use (RELIEF)

This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D symptoms.

Being tested
Eluxadoline, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EluxadolineDrug

    Also called VIBERZI™

    Eluxadoline 100 mg oral tablets BID with food.

  • PlaceboDrug

    Placebo matching eluxadoline oral tablets BID with food.

Study groups in NCT02959983
Study groupRoleWhat they receive
EluxadolineActive comparatorEluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
Receives: Drug: Eluxadoline
PlaceboPlacebo comparatorPlacebo matching eluxadoline oral tablets BID with food for 12 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores

    Percentage of primary composite responders is defined as the percentage of participants who meet both of the following daily composite criteria for at least 50% of the days with diary entry: 1)Worst Abdominal Pain (WAP) score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) Bristol Stool Score (BSS) <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool).

    Measured: Baseline, Weeks 1 to 12

Secondary outcomes (3)

  1. Percentage of Stool Consistency Responders

    Percentage of stool consistency responders is defined as the percentage of participants who meet the daily stool consistency response criteria: BSS <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline for ≥50% of days with daily patient diary entries over a certain time period. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool). A participant must have had a minimum of 20 days of diary entries over any 4-week interval.

    Measured: Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)

  2. Percentage of Pain Responders

    Percentage of pain responders is defined as the percentage of participants who meet the daily pain response criteria: WAP score improved by ≥40% compared to Baseline for ≥50% of days with diary entries over a certain time period. The participant records their WAP score in the past 24 hours each day in a daily diary where: 0=no pain to 10=worst imaginable pain. A participant must have had a minimum of 20 days of diary entries over any 4-week interval.

    Measured: Baseline, Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)

  3. Percentage of Monthly Composite Responders

    Percentage of monthly composite responders is defined as the percentage of participants who meet the daily composite response criteria for at least 50% of days with diary entry for a minimum of 20 days during each 4-week interval (weeks 1 to 4, 5 to 8, and 9 to 12). Composite response includes both of the following criteria: 1) WAP score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) BSS <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool).

    Measured: Weeks 1 to 4, 5 to 8, and 9 to 12

Timeline

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

  1. First posted9 Nov 2016 (estimated)
  2. Study start25 Oct 2016
  3. Primary completion22 Jan 2018
  4. Study completion22 Jan 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02959983
Sponsor's protocol ID
CMO-US-GI-0429
Status last verified
Jan 2019
First submitted
7 Nov 2016
Last updated
15 Feb 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Eluxadoline in people with Irritable Bowel Syndrome With Diarrhea, run by Allergan at 83 sites in 2 countries.

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 8 inclusion and 25 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores (time frame: Baseline, Weeks 1 to 12). 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 NCT02959983.

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 15 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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