Irritable Bowel SyndromePhase 2NCT01130272

Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

A Phase 2 study testing Eluxadoline in people with Irritable Bowel Syndrome, run by Furiex Pharmaceuticals, Inc at 288 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

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

Who is it for?: Ages 18 to 65 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: 807 participants
Where: 288 sitesUnited States
Study dates: 28 Apr 2010to 14 Jul 2011
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
Female patients must be:
postmenopausal, defined as amenorrhea 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

Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
Patient has a history of diverticulitis within 6 months prior to Prescreening
Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.
Other protocol-specific eligibility criteria may apply.

Trial locations and contacts

288 sites in 1 country.

City, postcode or hospital

288 sites in 1 country

United States288 sites

Furiex Research Site
Akron, Ohio, 44302
Furiex Research Site
Albuquerque, New Mexico, 87102
Furiex Research Site
Albuquerque, New Mexico, 87108
Furiex Research Site
Alexandria, Virginia, 22304
Furiex Research Site
Aliso Viejo, California, 92656
Furiex Research Site
Anaheim, California, 92801
Furiex Research Site
Anderson, Indiana, 46016
Furiex Research Site
Anderson, South Carolina, 29621
Furiex Research Site
Annapolis, Maryland, 21401
Furiex Research Site
Anniston, Alabama, 36207
Furiex Research Site
Atco, New Jersey, 08044
Furiex Research Site
Atlanta, Georgia, 30312
Furiex Research Site
Atlanta, Georgia, 30338
Furiex Research Site
Austin, Texas, 78705
Furiex Research Site
Aventura, Florida, 33916
Furiex Research Site
Azusa, California, 91702
Furiex Research Site
Beachwood, Ohio, 44122
Furiex Research Site
Beavercreek, Ohio, 45432
Furiex Research Site
Bedford, Texas, 76022
Furiex Research Site
Bellevue, Nebraska, 68005
Furiex Research Site
Billings, Montana, 59102
Furiex Research Site
Binghamton, New York, 13903
Furiex Research Site
Birmingham, Alabama, 35216
Furiex Research Site
Birmingham, Alabama, 35235
Furiex Research Site
Blackwood, New Jersey, 08012
Furiex Research Site
Bloomington, Indiana, 47403
Furiex Research Site
Boca Raton, Florida, 33428
Furiex Research Site
Boca Raton, Florida, 33432
Furiex Research Site
Boise, Idaho, 83702
Furiex Research Site
Boise, Idaho, 83704
Furiex Research Site
Boone, North Carolina, 28607
Furiex Research Site
Boston, Massachusetts, 02114
Furiex Research Site
Boston, Massachusetts, 02135
Furiex Research Site
Boston, Massachusetts, 02215
Furiex Research Site
Bowling Green, Kentucky, 42101
Furiex Research Site
Bozeman, Montana, 59718
Furiex Research Site
Bradenton, Florida, 34208
Furiex Research Site
Brandon, Florida, 33511
Furiex Research Site
Bristol, Connecticut, 06010
Furiex Research Site
Bristol, Tennessee, 37620
Furiex Research Site
Brockton, Massachusetts, 02301
Furiex Research Site
Brooklyn, New York, 11214
Furiex Research Site
Brooklyn, New York, 11230
Furiex Research Site
Burbank, California, 91505
Furiex Research Site
Carlsbad, California, 92008
Furiex Research Site
Champaign, Illinois, 61820
Furiex Research Site
Chandler, Arizona, 85224
Furiex Research Site
Chapel Hill, North Carolina, 27599
Furiex Research Site
Charlotte, North Carolina, 28209
Furiex Research Site
Charlotte, North Carolina, 28277
Furiex Research Site
Chaska, Minnesota, 55318
Furiex Research Site
Chattanooga, Tennessee, 37404
Furiex Research Site
Chattanooga, Tennessee, 37421
Furiex Research Site
Chesapeake, Virginia, 23320
Furiex Research Site
Chesterfield, Michigan, 48047
Furiex Research Site
Chevy Chase, Maryland, 20815
Furiex Research Site
Chicago, Illinois, 60634
Furiex Research Site
Chipley, Florida, 32428
Furiex Research Site
Christiansburg, Virginia, 24073
Furiex Research Site
Cincinnati, Ohio, 45229
Furiex Research Site
City of Saint Peters, Missouri, 63376
Furiex Research Site
Cleveland, Ohio, 44122
Furiex Research Site
Colleyville, Texas, 76034
Furiex Research Site
Colorado Springs, Colorado, 80904
Furiex Research Site
Colorado Springs, Colorado, 80907
Furiex Research Site
Colorado Springs, Colorado, 80920
Furiex Research Site
Colorado Springs, Colorado, 80922
Furiex Research Site
Columbia, South Carolina, 29201
Furiex Research Site
Columbia, South Carolina, 29203
Furiex Research Site
Columbus, Georgia, 31904
Furiex Research Site
Columbus, Ohio, 43214
Furiex Research Site
Columbus, Ohio, 43215
Furiex Research Site
Cumberland, Rhode Island, 02864
Furiex Research Site
Danville, Virginia, 24541
Furiex Research Site
Dayton, Ohio, 45432
Furiex Research Site
DeLand, Florida, 32720
Furiex Research Site
Delray Beach, Florida, 33484
Furiex Research Site
Denver, Colorado, 80222
Furiex Research Site
Denver, Colorado, 80239
Furiex Research Site
Dingmans Ferry, Pennsylvania, 18328
Furiex Research Site
Doral, Florida, 33172
Furiex Research Site
Dothan, Alabama, 36305
Furiex Research Site
Duluth, Georgia, 30096
Furiex Research Site
East Providence, Rhode Island, 02914
Furiex Research Site
El Paso, Texas, 79902
Furiex Research Site
Elizabeth, New Jersey, 07202
Furiex Research Site
Encinitas, California, 92024
Furiex Research Site
Evansville, Indiana, 47714
Furiex Research Site
Fairfax, Virginia, 22031
Furiex Research Site
Fargo, North Dakota, 58103
Furiex Research Site
Fargo, North Dakota, 58104
Furiex Research Site
Fayetteville, North Carolina, 28304
Furiex Research Site
Fort Lauderdale, Florida, 33306
Furiex Research Site
Fort Worth, Texas, 76107
Furiex Research Site
Fort Worth, Texas, 76108
Furiex Research Site
Franklin, Ohio, 45005
Furiex Research Site
Garden Grove, California, 92840
Furiex Research Site
Garden Grove, California, 92843
Furiex Research Site
Germantown, Tennessee, 38138
Furiex Research Site
Glendale, Arizona, 85308
Furiex Research Site
Grand Prairie, Texas, 75052
Furiex Research Site
Grapevine, Texas, 76051
Furiex Research Site
Great Neck, New York, 11021
Furiex Research Site
Great Neck, New York, 11023
Furiex Research Site
Greensboro, North Carolina, 27401
Furiex Research Site
Greensboro, North Carolina, 27403
Furiex Research Site
Greenville, North Carolina, 27834
Furiex Research Site
Greer, South Carolina, 29651
Furiex Research Site
Harrisburg, North Carolina, 28075
Furiex Research Site
Henderson, Nevada, 89052
Furiex Research Site
Hermitage, Pennsylvania, 16148
Furiex Research Site
Hialeah, Florida, 33013
Furiex Research Site
Hialeah, Florida, 33016
Furiex Research Site
Hickory, North Carolina, 28601
Furiex Research Site
Hickory, North Carolina, 28602
Furiex Research Site
High Point, North Carolina, 27262
Furiex Research Site
Hollywood, Maryland, 20636
Furiex Research Site
Houston, Texas, 77005
Furiex Research Site
Houston, Texas, 77022
Furiex Research Site
Houston, Texas, 77030
Furiex Research Site
Houston, Texas, 77034
Furiex Research Site
Houston, Texas, 77074
Furiex Research Site
Houston, Texas, 77081
Furiex Research Site
Houston, Texas, 77090
Furiex Research Site
Houston, Texas, 77505
Furiex Research Site
Huntsville, Alabama, 35801
Furiex Research Site
Huntsville, Alabama, 35802
Furiex Research Site
Hurst, Texas, 76054
Furiex Research Site
Hyannis, Massachusetts, 02601
Furiex Research Site
Idaho Falls, Idaho, 83404
Furiex Research Site
Indianapolis, Indiana, 46205
Furiex Research Site
Indianapolis, Indiana, 46237
Furiex Research Site
Indianapolis, Indiana, 46250
Furiex Research Site
Inglewood, California, 90301
Furiex Research Site
Interlochen, Michigan, 49643
Furiex Research Site
Inverness, Florida, 34452
Furiex Research Site
Irving, Texas, 75061
Furiex Research Site
Jackson, Mississippi, 39202
Furiex Research Site
Jackson, Tennessee, 38301
Furiex Research Site
Jacksonville, Florida, 32209
Furiex Research Site
Jacksonville, Florida, 32256
Furiex Research Site
Jacksonville, North Carolina, 28546
Furiex Research Site
Jenkintown, Pennsylvania, 19046
Furiex Research Site
Johnson City, Tennessee, 37604
Furiex Research Site
Jonesboro, Arkansas, 72401
Furiex Research Site
Jupiter, Florida, 33458
Furiex Research Site
Kalamazoo, Michigan, 49009
Furiex Research Site
Kingsport, Tennessee, 37660
Furiex Research Site
Kissimmee, Florida, 34741
Furiex Research Site
Laguna Hills, California, 92653
Furiex Research Site
Lake Jackson, Texas, 77566
Furiex Research Site
Lakewood, Colorado, 80215
Furiex Research Site
Lancaster, Pennsylvania, 17604
Furiex Research Site
Lansdale, Pennsylvania, 19446
Furiex Research Site
Largo, Florida, 33777
Furiex Research Site
Las Vegas, Nevada, 89106
Furiex Research Site
Las Vegas, Nevada, 89183
Furiex Research Site
Lauderdale Lakes, Florida, 33319
Furiex Research Site
Laurel, Maryland, 20707
Furiex Research Site
Lenexa, Kansas, 66215
Furiex Research Site
Lexington, Kentucky, 40504
Furiex Research Site
Little Rock, Arkansas, 72211
Furiex Research Site
Littleton, Colorado, 80120
Furiex Research Site
Logan, Utah, 84341
Furiex Research Site
Long Beach, California, 90806
Furiex Research Site
Los Angeles, California, 90015
Furiex Research Site
Los Angeles, California, 90045
Furiex Research Site
Louisville, Kentucky, 40202
Furiex Research Site
Lutherville, Maryland, 21093
Furiex Research Site
Macon, Georgia, 31201
Furiex Research Site
Madison, Wisconsin, 53715
Furiex Research Site
Marietta, Georgia, 30066
Furiex Research Site
Marlton, New Jersey, 08053
Furiex Research Site
Marshall, Texas, 75670
Furiex Research Site
Melbourne, Florida, 32935
Furiex Research Site
Mentor, Ohio, 44060
Furiex Research Site
Meridian, Idaho, 83642
Furiex Research Site
Mesa, Arizona, 85203
Furiex Research Site
Metairie, Louisiana, 70006
Furiex Research Site
Mexico, Missouri, 65265
Furiex Research Site
Miami, Florida, 33126
Furiex Research Site
Miami, Florida, 33135
Furiex Research Site
Miami, Florida, 33155
Furiex Research Site
Miamisburg, Ohio, 45342-3705
Furiex Research Site
Mill Creek, Washington, 98012-6316
Furiex Research Site
Milwaukee, Wisconsin, 53226
Furiex Research Site
Mineola, New York, 11501
Furiex Research Site
Mission, Kansas, 66202
Furiex Research Site
Mobile, Alabama, 36693
Furiex Research Site
Monroe, Louisiana, 71201
Furiex Research Site
Montgomery, Alabama, 36109
Furiex Research Site
Morristown, New Jersey, 07960
Furiex Research Site
Morton, Illinois, 61550
Furiex Research Site
Mt. Pleasant, South Carolina, 29464
Furiex Research Site
Murrieta, California, 92562
Furiex Research Site
Nampa, Idaho, 83686
Furiex Research Site
Naples, Florida, 34102
Furiex Research Site
Naples, Florida, 34109
Furiex Research Site
Nashville, Tennessee, 37203
Furiex Research Site
Nashville, Tennessee, 37205
Furiex Research Site
New Bern, North Carolina, 28562
Furiex Research Site
New Port Richey, Florida, 34652
Furiex Research Site
New Port Richey, Florida, 34655
Furiex Research Site
New Smyrna Beach, Florida, 32168
Furiex Research Site
New York, New York, 10016
Furiex Research Site
Newnan, Georgia, 30263
Furiex Research Site
Newton, Pennsylvania, 18940
Furiex Research Site
Norman, Oklahoma, 73069
Furiex Research Site
Norman, Oklahoma, 73071
Furiex Research Site
North Richland Hills, Texas, 76180
Furiex Research Site
Novi, Michigan, 48377
Furiex Research Site
Oakland, California, 94609
Furiex Research Site
Odessa, Texas, 79761
Furiex Research Site
Ogden, Utah, 84405
Furiex Research Site
Oklahoma City, Oklahoma, 73104
Furiex Research Site
Oklahoma City, Oklahoma, 73112
Furiex Research Site
Omaha, Nebraska, 68114
Furiex Research Site
Omaha, Nebraska, 68144
Furiex Research Site
Opelousas, Louisiana, 70570
Furiex Research Site
Orange, California, 92869
Furiex Research Site
Orlando, Florida, 32837
Furiex Research Site
Overland Park, Kansas, 66202
Furiex Research Site
Overland Park, Kansas, 66215
Furiex Research Site
Pell City, Alabama, 35128
Furiex Research Site
Phoenix, Arizona, 85018
Furiex Research Site
Phoenix, Arizona, 85020
Furiex Research Site
Phoenix, Arizona, 85050
Furiex Research Site
Plano, Texas, 75074
Furiex Research Site
Plantation, Florida, 33317
Furiex Research Site
Port Orange, Florida, 32129
Furiex Research Site
Prince Frederick, Maryland, 20678
Furiex Research Site
Raleigh, North Carolina, 27609
Furiex Research Site
Raleigh, North Carolina, 27612
Furiex Research Site
Rapid City, South Dakota, 57702
Furiex Research Site
Rockville, Maryland, 20850
Furiex Research Site
Rome, Georgia, 30165
Furiex Research Site
Sacramento, California, 95825
Furiex Research Site
Salt Lake City, Utah, 84109
Furiex Research Site
Salt Lake City, Utah, 84121
Furiex Research Site
San Antonio, Texas, 78209
Furiex Research Site
San Antonio, Texas, 78212
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 Carlos, California, 94070
Furiex Research Site
San Diego, California, 92103-6204
Furiex Research Site
San Diego, California, 92120
Furiex Research Site
Sandy Springs, Georgia, 30328
Furiex Research Site
Savannah, Georgia, 31406
Furiex Research Site
Sayre, Pennsylvania, 18840
Furiex Research Site
Searcy, Arkansas, 72143
Furiex Research Site
Sherwood, Arkansas, 72120
Furiex Research Site
Shreveport, Louisiana, 71101
Furiex Research Site
Shreveport, Louisiana, 71103
Furiex Research Site
South Bound Brook, New Jersey, 08880
Furiex Research Site
South Jordan, Utah, 84095
Furiex Research Site
South Miami, Florida, 33143
Furiex Research Site
Springfield, Massachusetts, 01105
Furiex Research Site
Springfield, Ohio, 45504
Furiex Research Site
St Louis, Missouri, 63141
Furiex Research Site
St. Petersburg, Florida, 33709
Furiex Research Site
Sugar Land, Texas, 77478
Furiex Research Site
Sugar Land, Texas, 77479
Furiex Research Site
Tampa, Florida, 33606
Furiex Research Site
Tampa, Florida, 33613
Furiex Research Site
Tempe, Arizona, 85282
Furiex Research Site
Tempe, Arizona, 85283
Furiex Research Site
Thornton, Colorado, 80229
Furiex Research Site
Topeka, Kansas, 66606
Furiex Research Site
Troy, Michigan, 48098
Furiex Research Site
Tucson, Arizona, 85704
Furiex Research Site
Tucson, Arizona, 85710
Furiex Research Site
Tupelo, Mississippi, 38801
Furiex Research Site
Uniontown, Pennsylvania, 15401
Furiex Research Site
Vineland, New Jersey, 08360
Furiex Research Site
Virginia Beach, Virginia, 23455
Furiex Research Site
Wadsworth, Ohio, 44281
Furiex Research Site
Warwick, Rhode Island, 02886
Furiex Research Site
Washington, Pennsylvania, 15301
Furiex Research Site
Waterbury, Connecticut, 06708
Furiex Research Site
Webster, Texas, 77598
Furiex Research Site
West Jordan, Utah, 84088
Furiex Research Site
West Valley City, Utah, 84120
Furiex Research Site
Wichita, Kansas, 67203
Furiex Research Site
Wilmington, North Carolina, 28401
Furiex Research Site
Winston-Salem, North Carolina, 27103-3914
Furiex Research Site
Winston-Salem, North Carolina, 27103
Furiex Research Site
Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea

Conditions: 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
Tablets, orally, twice daily.
PlaceboDrug
Matching placebo oral tablets twice daily.

Study groups in NCT01130272
Study group	Role	What they receive
Eluxadoline 5 mg	Experimental	Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Receives: Drug: Eluxadoline
Eluxadoline 25 mg	Experimental	Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. . Receives: Drug: Eluxadoline
Eluxadoline 100 mg	Experimental	Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Receives: Drug: Eluxadoline
Eluxadoline 200 mg	Experimental	Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Receives: Drug: Eluxadoline
Placebo	Placebo comparator	Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks. Receives: Drug: Placebo

What is being measured

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

Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 4
Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. Abdominal pain was assessed on an 11-point scale where: 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 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: Baseline (Week prior to Randomization) to Week 4
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12
Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. The participant recorded their abdominal pain in a daily diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The participant recorded stool consistency in a daily diary using the BSS 7-point scale where: 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: Baseline (Week prior to Randomization) to Week 12

Secondary outcomes (4)

Change From Baseline in the Weekly Pain Scores
The participant recorded their worst daily pain score in a diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement.
Measured: Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in Weekly BSS Scores
The patient recorded stool consistency in a daily diary using the BSS 7-point scale where: 1=hard stool to 7=watery diarrhea. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement.
Measured: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in the Number of Daily Bowel Movements
Participants recorded the number of bowel movements in a daily diary at the same time each day. The number of daily bowel movements over the previous week were averaged. A negative change from Baseline indicates improvement.
Measured: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time
Responders were participants that met both of the following criteria on the same week for at least 50% of time on study: 1) average of daily pain scores over the past week improved by ≥30% compared with baseline average in pain score, 2) ≥50% reduction in the number of days over the past week with a BSS score ≥5 compared with Baseline. Participants must also have had at least 5/7 days diary entry to be considered a responder for that week. Abdominal pain was assessed on an 11-point scale where a score of 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 1=separate hard lumps to 7=watery with no solid pieces. Response rates (percentage of participants) are based on model estimates from the logistic regression.
Measured: Baseline (Week Prior to Randomization) to Weeks 1-12

Timeline

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

28 Apr 201014 Jul 2011

First posted25 May 2010 (estimated)
Study start28 Apr 2010
Primary completion14 Jul 2011
Study completion14 Jul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 807 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01130272
Sponsor's protocol ID: 27018966IBS2001
Status last verified: Sep 2019
First submitted: 24 May 2010
Last updated: 22 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
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
Andrae DA, Covington PS, Patrick DL. Item-level assessment of the irritable bowel syndrome quality of life questionnaire in patients with diarrheal irritable bowel syndrome. Clin Ther. 2014 May;36(5):663-79. doi: 10.1016/j.clinthera.2014.04.009. Epub 2014 May 9.
PubMed 24813429
Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.
PubMed 23583433

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea
ClinicalTrials.gov ID: NCT01130272
Acronym / sponsor ID: 27018966IBS2001
Conditions: Irritable Bowel Syndrome
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
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 807 participants (actual)
Lead sponsor: Furiex Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: 28 Apr 2010 (actual)
Primary completion: 14 Jul 2011 (actual)
Study completion: 14 Jul 2011 (actual)
First posted: 25 May 2010 (estimated)
Results: Posted 22 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Eluxadoline 5 mg	Experimental	Drug: EluxadolineEluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline 25 mg	Experimental	Drug: EluxadolineEluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
Eluxadoline 100 mg	Experimental	Drug: EluxadolineEluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline 200 mg	Experimental	Drug: EluxadolineEluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboEluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
Female patients must be:
postmenopausal, defined as amenorrhea 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

Key exclusion criteria (5 listed)

Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
Patient has a history of diverticulitis within 6 months prior to Prescreening
Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.
Other protocol-specific eligibility criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EluxadolineAlso: JNJ-27018966Tablets, orally, twice daily.	Drug	Eluxadoline 100 mg, Eluxadoline 200 mg, Eluxadoline 25 mg, Eluxadoline 5 mg
PlaceboMatching placebo oral tablets twice daily.	Drug	Placebo

Primary outcome

Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 4
Time frame: Baseline (Week prior to Randomization) to Week 4
Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. Abdominal pain was assessed on an 11-point scale where: 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 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.
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12
Time frame: Baseline (Week prior to Randomization) to Week 12
Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. The participant recorded their abdominal pain in a daily diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The participant recorded stool consistency in a daily diary using the BSS 7-point scale where: 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.

4 secondary outcomes

Change From Baseline in the Weekly Pain Scores
Time frame: Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in Weekly BSS Scores
Time frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in the Number of Daily Bowel Movements
Time frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time
Time frame: Baseline (Week Prior to Randomization) to Weeks 1-12

Results and safety

Results posted to the registry on 22 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eluxadoline 5 mg	107	48
Eluxadoline 25 mg	173	131
Eluxadoline 100 mg	169	121
Eluxadoline 200 mg	171	103
Placebo	169	117

Primary outcome: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 4

Time frame: Baseline (Week prior to Randomization) to Week 4. Number. Unit: percentage of participants

Measure	Eluxadoline 5 mg n = 105	Eluxadoline 25 mg n = 167	Eluxadoline 100 mg n = 163	Eluxadoline 200 mg n = 160	Placebo n = 159
Value	12.4	12.0	11.0	13.8	5.7

Eluxadoline 5 mg: Odds Ratio (OR): 2.457 (95% CI 0.994 to 6.077), p = 0.052, ANCOVA
Eluxadoline 25 mg: Odds Ratio (OR): 2.383 (95% CI 1.036 to 5.478), p = 0.041, ANCOVA
Eluxadoline 100 mg: Odds Ratio (OR): 2.079 (95% CI 0.893 to 4.842), p = 0.090, ANCOVA

Population analysed: Intent to treat (ITT) set was defined as the 754 participants that received at least 1 dose of study drug and had baseline and at least 1 postrandomization daily pain rating and 1 postrandomization Bristol Stool Scale (BSS) rating.

Primary outcome: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12

Time frame: Baseline (Week prior to Randomization) to Week 12. Number. Unit: percentage of participants

Measure	Eluxadoline 5 mg n = 105	Eluxadoline 25 mg n = 167	Eluxadoline 100 mg n = 163	Eluxadoline 200 mg n = 160	Placebo n = 159
Value	8.6	13.2	20.2	15.0	11.3

Eluxadoline 5 mg: Odds Ratio (OR): 0.719 (95% CI 0.306 to 1.689), p = 0.449, ANCOVA
Eluxadoline 25 mg: Odds Ratio (OR): 1.208 (95% CI 0.615 to 2.373), p = 0.583, ANCOVA
Eluxadoline 100 mg: Odds Ratio (OR): 2.014 (95% CI 1.069 to 3.795), p = 0.030, ANCOVA

Population analysed: ITT analysis set was defined as the 754 participants that received at least 1 dose of study drug and had baseline and at least 1 postrandomization daily pain rating and 1 postrandomization Bristol Stool Scale (BSS) rating.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of study drug and up to and including 7 days after date of the last dose of study drug (Up to 114 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 159 (0.6%)	25 of 159 (15.7%)	Not reported
Eluxadoline 5 mg	1 of 105 (1%)	20 of 105 (19%)	Not reported
Eluxadoline 25 mg	3 of 170 (1.8%)	34 of 170 (20%)	Not reported
Eluxadoline 100 mg	1 of 165 (0.6%)	27 of 165 (16.4%)	Not reported
Eluxadoline 200 mg	3 of 172 (1.7%)	43 of 172 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28167156Fant 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.
Derived from this study: PubMed 24813429Andrae DA, Covington PS, Patrick DL. Item-level assessment of the irritable bowel syndrome quality of life questionnaire in patients with diarrheal irritable bowel syndrome. Clin Ther. 2014 May;36(5):663-79. doi: 10.1016/j.clinthera.2014.04.009. Epub 2014 May 9.
Derived from this study: PubMed 23583433Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

288 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eluxadoline in people with Irritable Bowel Syndrome, run by Furiex Pharmaceuticals, Inc at 288 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 5 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 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 288 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Oct 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 at Week 4 (time frame: Baseline (Week prior to Randomization) to Week 4). 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 NCT01130272, which also lists 3 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 22 Oct 2019.