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CompletedNCT02959983Updated Feb 15, 2019Results posted

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 interventional study of Eluxadoline and Placebo in Irritable Bowel Syndrome With Diarrhea, sponsored by Allergan. Completed at 83 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Allergan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
346
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome With Diarrhea
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 346 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. Has documented weight loss within the past 6 months; or
    2. Has nocturnal symptoms; or
    3. Has a familial history of colon cancer; or
    4. 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

  • Has any of the following surgical history:

    1. Cholecystectomy or previously documented agenesis of gallbladder; or
    2. Any abdominal surgery within the 3 months prior to screening; or
    3. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
346 participants (actual)

Study arms

  • Active comparator
    Eluxadoline

    Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.

    Drug: Eluxadoline

  • Placebo comparator
    Placebo

    Placebo matching eluxadoline oral tablets BID with food for 12 weeks.

    Drug: Placebo

Interventions

  • DrugEluxadoline

    Eluxadoline 100 mg oral tablets BID with food.

    Also known as: VIBERZI™

  • DrugPlacebo

    Placebo matching eluxadoline oral tablets BID with food.

06

What researchers measure

Primary outcomes

  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).

    Time frame: Baseline, Weeks 1 to 12

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: Weeks 1 to 4, 5 to 8, and 9 to 12

07

Results

Posted Feb 15, 2019

Participant flow

Participant flow — Overall Study
MilestoneEluxadolinePlacebo
Started172174
Completed146149
Not completed2625
Withdrew: Protocol violation01
Withdrew: Lack of efficacy01
Withdrew: Lost to follow-up129
Withdrew: Other11
Withdrew: Physician decision10
Withdrew: Adverse event51
Withdrew: Withdrawal by subject712

Outcome measures

PrimaryPercentage 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).

Time frame:
Baseline, Weeks 1 to 12
Reported as:
Number · percentage of participants
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
percentage of participantsEluxadolinePlacebo
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores22.710.3
Statistical analysis
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0022
SecondaryPercentage 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.

Time frame:
Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)
Reported as:
Number · Percentage of Participants
Percentage of Stool Consistency Responders
Percentage of ParticipantsEluxadolinePlacebo
Overall Weeks 1 to 1227.916.7
Weeks 1 to 424.412.6
Weeks 5 to 830.820.1
Weeks 9 to 1229.725.3
Statistical analysis
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0119
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0048
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0207
  • Eluxadoline vs Placebo · Chi-squared · p = 0.3700
SecondaryPercentage 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.

Time frame:
Baseline, Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)
Reported as:
Number · Percentage of Participants
Percentage of Pain Responders
Percentage of ParticipantsEluxadolinePlacebo
Overall Weeks 1 to 1243.631.0
Weeks 1 to 430.225.9
Weeks 5 to 845.931.6
Weeks 9 to 1244.835.1
Statistical analysis
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0174
  • Eluxadoline vs Placebo · Chi-squared · p = 0.3832
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0052
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0619
SecondaryPercentage 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).

Time frame:
Weeks 1 to 4, 5 to 8, and 9 to 12
Reported as:
Number · Percentage of Participants
Percentage of Monthly Composite Responders
Percentage of ParticipantsEluxadolinePlacebo
Weeks 1-4146.9
Weeks 5-826.714.9
Weeks 9-1230.816.7
Statistical analysis
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0330
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0063
  • Eluxadoline vs Placebo · Chi-squared · p = 0.0018

Adverse events

Collected over Up to 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Eluxadoline0/171 (0%)1/171 (0.6%)10/171 (5.8%)
Placebo0/173 (0%)3/173 (1.7%)5/173 (2.9%)
Most frequent serious events
Most frequent serious events
EventEluxadolinePlacebo
Pancreatic massGastrointestinal disorders1/1710/173
CellulitisInfections and infestations0/1711/173
PneumoniaInfections and infestations0/1711/173
Cardiac failure congestiveCardiac disorders0/1711/173
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1711/173
DysmenorrheaReproductive system and breast disorders0/1711/173
EndometriosisReproductive system and breast disorders0/1711/173
Ovarian cystReproductive system and breast disorders0/1711/173
Pelvic painReproductive system and breast disorders0/1711/173
Most frequent other events
Most frequent other events
EventEluxadolinePlacebo
NauseaGastrointestinal disorders10/1715/173

Baseline characteristics

The Intent-to-Treat population includes all randomized patients.

Age, Customized
Age, Customized(Participants)EluxadolinePlaceboTotal
<65158161319
≥65141327
Sex: Female, Male
Sex: Female, Male(Participants)EluxadolinePlaceboTotal
Female124119243
Male4855103
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)EluxadolinePlaceboTotal
Hispanic or Latino334174
Not Hispanic or Latino139133272
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)EluxadolinePlaceboTotal
Caucasian144141285
Black or African American202646
Asian7310
American Indian or Alaskan Native123
Native Hawaiian or Other Pacific Islander011
Other011
08

Study locations

83 sites
  • Clinical Research Associates, LLC
    Huntsville, Alabama 35801, United States
  • The Center for Clinical Trials
    Saraland, Alabama 36571, United States
  • Elite Clinical Studies
    Phoenix, Arizona 85018, United States
  • Arkansas Gastroenterology
    North Little Rock, Arkansas 72117, United States
  • Med Investigations
    Carmichael, California 95608, United States
  • GW Research Inc
    Chula Vista, California 91910, United States
  • Diagnamics Inc
    Encinitas, California 92024, United States
  • Behavioral Research Specialists, LLC
    Irvine, California 92606, United States
  • Providence Clinical Research
    North Hollywood, California 91606, United States
  • Shahram Jacobs MD INC.
    Sherman Oaks, California 91403, United States
  • Westlake Medical Research
    Thousand Oaks, California 91360, United States
  • Upland Clinical Research
    Upland, California 91786, United States
  • Advanced RX Clinicial Research Group, Inc.
    Westminster, California 92683, United States
  • Connecticut Clinical Research Foundation
    Bristol, Connecticut 06010, United States
  • Medical Research Center of Connecticut, LLC
    Hamden, Connecticut 06518, United States
  • Innovative Research of West Florida, Inc.
    Clearwater, Florida 33756, United States
  • Digestive Care of N. Broward
    Coral Springs, Florida 33065, United States
  • Homestead Medical Research
    Homestead, Florida 33030, United States
  • Clinical Neuroscience Solutions Inc.
    Jacksonville, Florida 32256, United States
  • Health Awareness, Inc.
    Jupiter, Florida 33458, United States
  • Precision Clinical Research LLC
    Lauderdale Lakes, Florida 33319, United States
  • Ocean Blue Medical Research Center, Inc
    Miami Springs, Florida 33166, United States
  • Pharmax Research Clinic Inc.
    Miami, Florida 33126, United States
  • Well Pharma Medical Research, Corp.
    Miami, Florida 33143, United States
  • Bravo Health Care Center
    North Bay Village, Florida 33141, United States
  • Clinical Neuroscience Solutions Inc.
    Orlando, Florida 32801, United States
  • Clinical Research of West Florida Inc.
    Tampa, Florida 33603, United States
  • Meridien Research
    Tampa, Florida 33634, United States
  • Emory University School of Medicine
    Atlanta, Georgia 30322, United States
  • RNA America, LLC
    Buford, Georgia 30518, United States
  • Northwestern University Feinbery School of Medicine
    Chicago, Illinois 606611, United States
  • Pharmakon Inc
    Evergreen Park, Illinois 60805, United States
  • Investigators Research
    Brownsburg, Indiana 46112, United States
  • Radiant Research, Inc.
    Evansville, Indiana 47714, United States
  • Clinical Research Advantage Inc/Radiant Research Inc.
    Evansville, Indiana 47725, United States
  • Gtc Research
    Shawnee Mission, Kansas 66218, United States
  • Investigative Clinical Research
    Annapolis, Maryland 21401, United States
  • MGG Group Co. Inc. Chevy Chase Clinical Research
    Chevy Chase, Maryland 20815, United States
  • MedVadis Research Corporation
    Watertown, Massachusetts 02472, United States
  • Clinical Research Insititute of Michigan LLC
    Chesterfield, Michigan 48047, United States
  • Gastroenterology Associates of Western Michigan, PLC
    Wyoming, Michigan 49519, United States
  • The Center for Clinical Trials
    Biloxi, Mississippi 39531, United States
  • Women's Clinic of Lincoln, P.C.
    Lincoln, Nebraska 68510, United States
  • Quality Clinical Research Inc.
    Omaha, Nebraska 68114, United States
  • Advanced Biomedical Research of America
    Las Vegas, Nevada 89123, United States
  • Advanced Research Institute
    Reno, Nevada 89511, United States
  • Drug Trials Brooklyn
    Brooklyn, New York 11230, United States
  • NY Scientific
    Brooklyn, New York 11235, United States
  • Long Island Gastrointestinal Group LLP
    Great Neck, New York 11023, United States
  • IMA Medical Research, PC
    Kew Gardens, New York 11415, United States
  • Charlotte Gastroenterology & Hepatology, PLLC
    Charlotte, North Carolina 28207, United States
  • Peters Medical Research LLC
    High Point, North Carolina 27265, United States
  • North State Clincial Research PLLC
    Lenoir, North Carolina 28645, United States
  • Wake Research Associates LLC
    Raleigh, North Carolina 27612, United States
  • Trial Management Associates, LLC
    Wilmington, North Carolina 28403, United States
  • Clinical Inquest Center Ltd
    Beavercreek, Ohio 45431, United States
  • Hometown Urgent Care and Research
    Cincinnati, Ohio 45215, United States
  • Buckeye Health and Research
    Columbus, Ohio 43207, United States
  • Hometown Urgent Care and Research
    Columbus, Ohio 43214, United States
  • Hometown Urgent Care and Research
    Huber Heights, Ohio 45424, United States
  • Central Sooner Research
    Norman, Oklahoma 73071, United States
  • The Oregon Center for Clinical Investigations, INC.
    Salem, Oregon 97301, United States
  • Partners in Clinical Research
    Cumberland, Rhode Island 02864, United States
  • WR-ClinSearch, LLC
    Chattanooga, Tennessee 37421, United States
  • New Phase Research & Development
    Knoxville, Tennessee 37909, United States
  • CNS Healthcare
    Memphis, Tennessee 38119, United States
  • Premier Family Physicians
    Austin, Texas 78735, United States
  • Family Medicine Associate of Texas
    Carrollton, Texas 75010, United States
  • Multi-Phase Trials LLC
    San Antonio, Texas 78217, United States
  • Health Texas Research Institute
    San Antonio, Texas 78228, United States
  • Discovery Clinical Trials - Stone Oak
    San Antonio, Texas 78258, United States
  • Carl Meisner Medical Clinic
    Sugar Land, Texas 77478, United States
  • Advanced Research Institute - Ogden
    Ogden, Utah 84405, United States
  • Wasatch Clinical Research, LLC
    Salt Lake City, Utah 84107, United States
  • Gastroenterology Associates of Northern Virginia
    Fairfax, Virginia 22031, United States
  • Blue Ridge Medical Research
    Lynchburg, Virginia 24502, United States
  • Corunna Medical Research Centre
    Corunna, Ontario N0N 1G0, Canada
  • Manna Research
    Etobicoke, Ontario 7LM 4Y1, Canada
  • SKDS Research Inc
    Newmarket, Ontario L3Y 5G8, Canada
  • University of Calgary
    Calgary, T2N 1N4, Canada
  • Viable Clinical Research Corp.
    Nova Scotia, B4V 3N2, Canada
  • Centre de reserche St Louis
    Quebec, G1W4R4, Canada
  • Dynamik Research Inc
    Quebec, H9R 3J1, Canada
09

References and documents

Study documents

  • Study protocol · Aug 12, 2016
  • Statistical analysis plan · Oct 18, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02959983
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Nov 9, 2016
Start date
Oct 25, 2016
Primary completion
Jan 22, 2018
Completion
Jan 22, 2018
Results posted
Feb 15, 2019
Last update
Feb 15, 2019

Study contacts

Esther Jo
study director · Allergan

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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