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AzTrials

Irritable Bowel SyndromePhase 3NCT01553747

Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

A Phase 3 study testing Eluxadoline in people with Irritable Bowel Syndrome, run by Furiex Pharmaceuticals, Inc at 253 sites in 4 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

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Irritable Bowel Syndrome
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
1,146 participants
Where
253 sitesin 4 countries
Study dates
29 May 2012to 9 Jan 2014
Phase
Phase 3
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

  • Participant is 18 to 80 years old
  • Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
  • 2. Participant has had a colonoscopy performed:
  • Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
  • Since the onset (if applicable) of any of the following alarm features for participants of any age
  • Participant has documented weight loss within the past 6 months
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  • Participant has nocturnal symptoms
  • Participant has a familial history of first-degree relatives with colon cancer
  • Participant has blood mixed with their stool (excluding blood from hemorrhoids).
  • 3. Female participants must be:
  • Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
  • Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
  • Abstinent, or
  • If sexually active, be practicing an effective method of birth control.

Who cannot join

  • Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
  • Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
  • Participant has a history of diverticulitis within 3 months prior to Prescreening.
  • Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
  • Participant has any of the following surgical history:
  • Cholecystectomy with any history of post cholecystectomy biliary tract pain
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  • Any abdominal surgery within the 3 months prior to Prescreening
  • Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)
  • Other protocol-specific eligibility criteria may apply.

Trial locations and contacts

253 sites in 4 countries.

253 sites in 4 countries

United States232 sites

  • Furiex Research Site

    Addison, Illinois, 60101

  • Furiex Research Site

    Akron, Ohio, 44302

  • Furiex Research Site

    Albuquerque, New Mexico, 87102

  • Furiex Research Site

    Albuquerque, New Mexico, 87108

  • Furiex Research Site

    Albuquerque, New Mexico, 87109

  • Furiex Research Site

    Alexandria, Virginia, 22304

  • Furiex Research Site

    Alpharetta, Georgia, 30005

  • Furiex Research Site

    Anaheim, California, 92801

  • Furiex Research Site

    Anderson, South Carolina, 29621

  • Furiex Research Site

    Ann Arbor, Michigan, 48106

  • Furiex Research Site

    Athens, Georgia, 30606

  • Furiex Research Site

    Athens, Tennessee, 37303

  • Furiex Research Site

    Atlanta, Georgia, 30308

  • Furiex Research Site

    Atlanta, Georgia, 30338

  • Furiex Research Site

    Austin, Texas, 78745

  • Furiex Research Site

    Bay City, Michigan, 48706

  • Furiex Research Site

    Beaumont, Texas, 77701

  • Furiex Research Site

    Beavercreek, Ohio, 45431

  • Furiex Research Site

    Bedford, Texas, 76021

  • Furiex Research Site

    Bellevue, Nebraska, 68005

  • Furiex Research Site

    Billings, Montana, 59101

  • Furiex Research Site

    Biloxi, Mississippi, 39531

  • Furiex Research Site

    Birmingham, Alabama, 35209

  • Furiex Research Site

    Birmingham, Alabama, 35242

  • Furiex Research Site

    Blackwood, New Jersey, 08012

  • Furiex Research Site

    Boca Raton, Florida, 33428

  • Furiex Research Site

    Boise, Idaho, 83704

  • Furiex Research Site

    Boston, Massachusetts, 02115

  • Furiex Research Site

    Boston, Massachusetts, 02131

  • Furiex Research Site

    Bountiful, Utah, 84010

  • Furiex Research Site

    Boynton Beach, Florida, 33426

  • Furiex Research Site

    Bradenton, Florida, 34208

  • Furiex Research Site

    Brockton, Massachusetts, 02302

  • Furiex Research Site

    Brooksville, Florida, 34601

  • Furiex Research Site

    Brownsburg, Indiana, 46112

  • Furiex Research Site

    Burlington, Vermont, 05401

  • Furiex Research Site

    Cadillac, Michigan, 49601

  • Furiex Research Site

    Carnegie, Pennsylvania, 15106

  • Furiex Research Site

    Chapel Hill, North Carolina, 27599

  • Furiex Research Site

    Charleston, West Virginia, 25304

  • Furiex Research Site

    Chattanooga, Tennessee, 37404

  • Furiex Research Site

    Chicago, Illinois, 60612

  • Furiex Research Site

    Chicago, Illinois, 60622

  • Furiex Research Site

    Christiansburg, Virginia, 24073

  • Furiex Research Site

    Chula Vista, California, 91910

  • Furiex Research Site

    Cincinnati, Ohio, 45224

  • Furiex Research Site

    Cincinnati, Ohio, 45242

  • Furiex Research Site

    Cincinnati, Ohio, 45245

  • Furiex Research Site

    Cincinnati, Ohio, 45267

  • Furiex Research Site

    City of Saint Peters, Missouri, 63376

  • Furiex Research Site

    Clearwater, Florida, 33759

  • Furiex Research Site

    Cleveland, Ohio, 44122

  • Furiex Research Site

    Clive, Iowa, 50325

  • Furiex Research Site

    Columbia, South Carolina, 29201

  • Furiex Research Site

    Columbia, South Carolina, 29203

  • Furiex Research Site

    Columbia, South Carolina, 29204

  • Furiex Research Site

    Columbia, Tennessee, 38401

  • Furiex Research Site

    Columbus, Ohio, 43212

  • Furiex Research Site

    Columbus, Ohio, 43214

  • Furiex Research Site

    Columbus, Ohio, 43235

  • Furiex Research Site

    Cooper City, Florida, 33024

  • Furiex Research Site

    Coral Springs, Florida, 33065

  • Furiex Research Site

    Corsicana, Texas, 75110

  • Furiex Research Site

    Dallas, Texas, 75218

  • Furiex Research Site

    Dallas, Texas, 75225

  • Furiex Research Site

    Dayton, Ohio, 45432

  • Furiex Research Site

    Dayton, Ohio, 45439

  • Furiex Research Site

    Decatur, Alabama, 35603

  • Furiex Research Site

    Denver, Colorado, 80211

  • Furiex Research Site

    Denver, Colorado, 80246

  • Furiex Research Site

    Dunn, North Carolina, 28334

  • Furiex Research Site

    Dunwoody, Georgia, 30338

  • Furiex Research Site

    Eagle, Idaho, 83616

  • Furiex Research Site

    Easley, South Carolina, 29640

  • Furiex Research Site

    Edison, New Jersey, 08817

  • Furiex Research Site

    Elizabeth, New Jersey, 07201

  • Furiex Research Site

    Elkhorn, Nebraska, 68022

  • Furiex Research Site

    Encinitas, California, 92024

  • Furiex Research Site

    Eustis, Florida, 32726

  • Furiex Research Site

    Evansville, Indiana, 47714

  • Furiex Research Site

    Evergreen Park, Illinois, 60805

  • Furiex Research Site

    Flushing, New York, 11367

  • Furiex Research Site

    Fort Lauderdale, Florida, 33308

  • Furiex Research Site

    Fort Worth, Texas, 76133

  • Furiex Research Site

    Frisco, Texas, 75035

  • Furiex Research Site

    Garden Grove, California, 92840

  • Furiex Research Site

    Glendale, Arizona, 85306

  • Furiex Research Site

    Glendale, Arizona, 85308

  • Furiex Research Site

    Grand Rapids, Michigan, 49506

  • Furiex Research Site

    Granger, Indiana, 46530

  • Furiex Research Site

    Greensboro, North Carolina, 27403

  • Furiex Research Site

    Groveport, Ohio, 43125

  • Furiex Research Site

    Hagerstown, Maryland, 21742

  • Furiex Research Site

    Hallandale, Florida, 33009

  • Furiex Research Site

    Hammond, Illinois, 46324

  • Furiex Research Site

    Hazelwood, Missouri, 63042

  • Furiex Research Site

    Hialeah, Florida, 33016

  • Furiex Research Site

    Hollis, New York, 11423

  • Furiex Research Site

    Hollywood, Maryland, 20636

  • Furiex Research Site

    Houston, Texas, 77008

  • Furiex Research Site

    Houston, Texas, 77043

  • Furiex Research Site

    Houston, Texas, 77062

  • Furiex Research Site

    Humble, Texas, 77338

  • Furiex Research Site

    Huntersville, North Carolina, 28078

  • Furiex Research Site

    Huntington Beach, California, 92647

  • Furiex Research Site

    Huntsville, Alabama, 35801

  • Furiex Research Site

    Hurst, Texas, 76054

  • Furiex Research Site

    Idaho Falls, Idaho, 83404

  • Furiex Research Site

    Irvine, California, 92604

  • Furiex Research Site

    Jackson, Tennessee, 38305

  • Furiex Research Site

    Jacksonville, Florida, 32205

  • Furiex Research Site

    Jonesboro, Arkansas, 72401

  • Furiex Research Site

    Jupiter, Florida, 33458

  • Furiex Research Site

    Kalamazoo, Michigan, 49009

  • Furiex Research Site

    Kettering, Ohio, 45429

  • Furiex Research Site

    Kinston, North Carolina, 28501

  • Furiex Research Site

    Knoxville, Tennessee, 37919

  • Furiex Research Site

    La Mesa, California, 91942

  • Furiex Research Site

    La Mirada, California, 90638

  • Furiex Research Site

    Laguna Hills, California, 92653

  • Furiex Research Site

    Lake Charles, Louisiana, 70601

  • Furiex Research Site

    Lakewood, California, 90805

  • Furiex Research Site

    Las Vegas, Nevada, 89123

  • Furiex Research Site

    Lauderdale Lakes, Florida, 33319

  • Furiex Research Site

    Lawrenceville, Georgia, 30046

  • Furiex Research Site

    Lebanon, New Hampshire, 03756

  • Furiex Research Site

    Lexington, Kentucky, 40503

  • Furiex Research Site

    Lexington, Kentucky, 40504

  • Furiex Research Site

    Lima, Ohio, 45806

  • Furiex Research Site

    Lincoln, California, 95648

  • Furiex Research Site

    Lincoln, Nebraska, 68510

  • Furiex Research Site

    Little Rock, Arkansas, 72205

  • Furiex Research Site

    Loma Linda, California, 92354

  • Furiex Research Site

    Lomita, California, 90717

  • Furiex Research Site

    Long Beach, California, 90806

  • Furiex Research Site

    Los Angeles, California, 90045

  • Furiex Research Site

    Macon, Georgia, 31201

  • Furiex Research Site

    Marietta, Georgia, 30066

  • Furiex Research Site

    Marlton, New Jersey, 08053

  • Furiex Research Site

    Melbourne, Florida, 32901

  • Furiex Research Site

    Mesa, Arizona, 85206

  • Furiex Research Site

    Miami, Florida, 33015

  • Furiex Research Site

    Miami, Florida, 33125

  • Furiex Research Site

    Miami, Florida, 33126

  • Furiex Research Site

    Miami, Florida, 33133

  • Furiex Research Site

    Miami, Florida, 33135

  • Furiex Research Site

    Miami, Florida, 33144

  • Furiex Research Site

    Miami, Florida, 33155

  • Furiex Research Site

    Miami, Florida, 33183

  • Furiex Research Site

    Midlothian, Virginia, 23114

  • Furiex Research Site

    Mineola, New York, 11501

  • Furiex Research Site

    Miramar, Florida, 33025

  • Furiex Research Site

    Mobile, Alabama, 36608

  • Furiex Research Site

    Monroe, Louisiana, 71201

  • Furiex Research Site

    Monroe, Wisconsin, 53566

  • Furiex Research Site

    Montgomery, Alabama, 36109

  • Furiex Research Site

    Mt. Pleasant, South Carolina, 29464

  • Furiex Research Site

    New Port Richey, Florida, 34652

  • Furiex Research Site

    New York, New York, 10016

  • Furiex Research Site

    Newport Beach, California, 92663

  • Furiex Research Site

    Norcross, Georgia, 30092

  • Furiex Research Site

    Norfolk, Virginia, 23502

  • Furiex Research Site

    Norman, Oklahoma, 73071

  • Furiex Research Site

    North Hollywood, California, 91606

  • Furiex Research Site

    North Myrtle Beach, South Carolina, 29582

  • Furiex Research Site

    Northridge, California, 91325

  • Furiex Research Site

    Oklahoma City, Oklahoma, 73102

  • Furiex Research Site

    Oklahoma City, Oklahoma, 73112

  • Furiex Research Site

    Omaha, Nebraska, 68134

  • Furiex Research Site

    Omaha, Nebraska, 68144

  • Furiex Research Site

    Orlando, Florida, 32806

  • Furiex Research Site

    Owensboro, Kentucky, 42303

  • Furiex Research Site

    Paducah, Kentucky, 42003

  • Furiex Research Site

    Pasadena, California, 91105

  • Furiex Research Site

    Philadelphia, Pennsylvania, 19107

  • Furiex Research Site

    Phoenix, Arizona, 85023

  • Furiex Research Site

    Phoenix, Arizona, 85032

  • Furiex Research Site

    Pittsburgh, Pennsylvania, 15206

  • Furiex Research Site

    Pittsburgh, Pennsylvania, 15243

  • Furiex Research Site

    Plant City, Florida, 33563

  • Furiex Research Site

    Plymouth, Minnesota, 55446

  • Furiex Research Site

    Port Orange, Florida, 32127

  • Furiex Research Site

    Portland, Oregon, 97210

  • Furiex Research Site

    Pratt, Kansas, 67124

  • Furiex Research Site

    Rapid City, South Dakota, 57702

  • Furiex Research Site

    Reno, Nevada, 89511

  • Furiex Research Site

    Richmond, Virginia, 23233

  • Furiex Research Site

    Richmond, Virginia, 23235

  • Furiex Research Site

    Sacramento, California, 95817

  • Furiex Research Site

    Salem, Oregon, 97301

  • Furiex Research Site

    Salt Lake City, Utah, 84124

  • Furiex Research Site

    San Antonio, Texas, 78215

  • Furiex Research Site

    San Antonio, Texas, 78229

  • Furiex Research Site

    San Antonio, Texas, 78258

  • Furiex Research Site

    San Diego, California, 92103

  • Furiex Research Site

    San Diego, California, 92105

  • Furiex Research Site

    Santa Ana, California, 92701

  • Furiex Research Site

    Savannah, Georgia, 31404

  • Furiex Research Site

    Scottdale, Pennsylvania, 15683

  • Furiex Research Site

    Shawnee Mission, Kansas, 66218

  • Furiex Research Site

    Sheffield, Alabama, 35660

  • Furiex Research Site

    Sherwood, Arkansas, 72120

  • Furiex Research Site

    Smyrna, Tennessee, 37167

  • Furiex Research Site

    South Miami, Florida, 33143

  • Furiex Research Site

    Springfield, Illinois, 62703

  • Furiex Research Site

    St Louis, Missouri, 63122

  • Furiex Research Site

    St Louis, Missouri, 63128

  • Furiex Research Site

    St Louis, Missouri, 63141

  • Furiex Research Site

    St. Petersburg, Florida, 33705

  • Furiex Research Site

    St. Petersburg, Florida, 33709

  • Furiex Research Site

    Stockbridge, Georgia, 30281

  • Furiex Research Site

    Tampa, Florida, 33607

  • Furiex Research Site

    Tiffin, Ohio, 44883

  • Furiex Research Site

    Toledo, Ohio, 43615

  • Furiex Research Site

    Topeka, Kansas, 66606

  • Furiex Research Site

    Troy, Michigan, 48098

  • Furiex Research Site

    Tucson, Arizona, 85704

  • Furiex Research Site

    Tucson, Arizona, 85712

  • Furiex Research Site

    Tuscaloosa, Alabama, 35401

  • Furiex Research Site

    Uniontown, Pennsylvania, 15401

  • Furiex Research Site

    Ventura, California, 93003

  • Furiex Research Site

    Walnut Creek, California, 94598

  • Furiex Research Site

    Warwick, Rhode Island, 02888

  • Furiex Research Site

    Watertown, Massachusetts, 02472

  • Furiex Research Site

    Wellington, Florida, 33414

  • Furiex Research Site

    West Valley City, Utah, 84120

  • Furiex Research Site

    Wilmington, North Carolina, 28403

  • Furiex Research Site

    Winston-Salem, North Carolina, 27103

  • Furiex Research Site

    Winston-Salem, North Carolina, 27106

  • Furiex Research Site

    Winter Haven, Florida, 33880

  • Furiex Research Site

    Winter Park, Florida, 32792

  • Furiex Research Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada10 sites

  • Furiex Research Site

    Burlington, Ontario, L7M 4Y1

  • Furiex Research Site

    Greater Sudbury, Ontario, P3E 1H5

  • Furiex Research Site

    Hawkesbury, Ontario, K6A 1A1

  • Furiex Research Site

    Kelowna, British Columbia, V1Y 3G8

  • Furiex Research Site

    London, Ontario, N5W 6A2

  • Furiex Research Site

    Newmarket, Ontario, L3Y 5G8

  • Furiex Research Site

    Sarnia, Ontario, N7T 4X3

  • Furiex Research Site

    St. John's, Newfoundland and Labrador, A1E 2E2

  • Furiex Research Site

    Toronto, Ontario, M6H 3M1

  • Furiex Research Site

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

United Kingdom10 sites

  • Furiex Research Site

    Birmingham, B15 2TH

  • Furiex Research Site

    Blackpool, Lancashire, FY4 3AD

  • Furiex Research Site

    Chestfield, Kent, CT5 3QS

  • Furiex Research Site

    County Durham, DL14 6AD

  • Furiex Research Site

    Coventry, CV2 2DX

  • Furiex Research Site

    Durham, DH1 5TW

  • Furiex Research Site

    Edinburgh, EH4 2XH

  • Furiex Research Site

    Manchester, M23 9LT

  • Furiex Research Site

    Sheffield, S10 2JF

  • Furiex Research Site

    Wigan, WN1 2NN

Other trials in United Kingdom

Puerto Rico1 site

  • Furiex Research Site

    San Juan, 00926-2832

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.

Being tested
Eluxadoline, Placebo
Keywords
Irritable bowel syndrome with diarrhea, Irritable bowel syndrome, Diarrhea predominant irritable bowel syndrome, Colonic diseases, Colonic diseases, functional, Digestive system disease, Gastrointestinal disease, Intestinal disease, Colonic pseudo-obstruction, Diarrhea, Signs and symptoms, Digestive
Medical subject headings
Irritable Bowel Syndrome, Colonic Diseases, Colonic Diseases, Functional, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Colonic Pseudo-Obstruction, Diarrhea

What participants receive

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

  • EluxadolineDrug

    Also called JNJ-27018966

    Oral tablets twice daily

  • PlaceboDrug

    Oral tablets twice daily

Study groups in NCT01553747
Study groupRoleWhat they receive
Eluxadoline 75 mgExperimentalEluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
Receives: Drug: Eluxadoline
Eluxadoline 100 mgExperimentalEluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
Receives: Drug: Eluxadoline
PlaceboPlacebo comparatorEluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
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

    Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.

    Measured: Up to 12 weeks

Secondary outcomes (13)

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

    Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.

    Measured: Up to 26 weeks

  2. Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals

    Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.

    Measured: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)

  3. Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals

    Stool consistency responders: Participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.

    Measured: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)

  4. Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals

    IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5-point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.

    Measured: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)

  5. Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale

    IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.

    Measured: Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])

  6. Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale

    Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder.

    Measured: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)

  7. Change From Baseline in Daily Abdominal Discomfort Scores

    Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.

    Measured: Baseline, Weeks 4, 12 and 26

  8. Change From Baseline in Daily Abdominal Bloating Scores

    Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.

    Measured: Baseline, Weeks 4, 12 and 26

  9. Number of Bowel Movements Per Day

    Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.

    Measured: Weeks 4, 12 and 26

  10. Number of Bowel Incontinence Episodes

    Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.

    Measured: Weeks 4, 12 and 26

  11. Number of Bowel Incontinence Free Days

    An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.

    Measured: Weeks 4, 12 and 26

  12. Number of Urgency Episodes Per Day

    Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.

    Measured: Weeks 4, 12 and 26

  13. Change From Baseline in IBS-QoL Total Scores

    The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.

    Measured: Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT

Timeline

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

  1. First posted14 Mar 2012 (estimated)
  2. Study start29 May 2012
  3. Primary completion9 Jan 2014
  4. Study completion9 Jan 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01553747
Sponsor's protocol ID
27018966IBS3002
Other IDs
2012-001601-24
Status last verified
Jul 2018
First submitted
8 Mar 2012
Last updated
30 Jul 2018
Data monitoring committee
No

Publications

  • Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.

    PubMed 28167156

  • Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.

    PubMed 26789872

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eluxadoline in people with Irritable Bowel Syndrome, run by Furiex Pharmaceuticals, Inc at 253 sites in 4 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 14 inclusion and 9 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 253 sites in United States, Canada, United Kingdom, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Jul 2018). 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: Up to 12 weeks). 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 NCT01553747, which also lists 2 linked publications.

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 30 Jul 2018.

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