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

August 3, 2018 updated by: Furiex Pharmaceuticals, Inc

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.

Study Overview

Status

Completed

Conditions

Irritable Bowel Syndrome

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1282

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Kamloops, British Columbia, Canada, V2C 1K7
    - Furiex research site
  - Kelowna, British Columbia, Canada, V1Y 1Z9
    - Furiex research site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1R9
    - Furiex research site
- Nova Scotia
  - Bridgewater, Nova Scotia, Canada, B4V 3N2
    - Furiex research site
  - Halifax, Nova Scotia, Canada, B3K 2M5
    - Furiex research site
- Ontario
  - Cambridge, Ontario, Canada, N1S 2M6
    - Furiex research site
  - London, Ontario, Canada, N6A 5R8
    - Furiex research site
  - Niagara Falls, Ontario, Canada, L2G 1J4
    - Furiex research site
  - Oshawa, Ontario, Canada, L1H 1B9
    - Furiex research site
United Kingdom
- - Bath, United Kingdom, BA2 3HT
    - Furiex research site
  - Bath, United Kingdom, BA2 4BY
    - Furiex research site
  - Coventry, United Kingdom, CV6 4DD
    - Furiex research site
  - Dorking, United Kingdom, RH4 1SD
    - Furiex research site
  - Haxey, United Kingdom, DN9 2HY
    - Furiex research site
  - London, United Kingdom, E11 1NR
    - Furiex research site
  - Shrewsbury, United Kingdom, SY3 8XQ
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  - Southampton, United Kingdom, SO16 6YD
    - Furiex research site
  - Strensall, United Kingdom, YO32 5UA
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  - Thornton, United Kingdom, FY5 2TZ
    - Furiex research site
  - Torpoint, United Kingdom, PL11 2JW
    - Furiex research site
- Derbyshire
  - Chesterfield, Derbyshire, United Kingdom, S40 4AA
    - Furiex research site
- Lancashire
  - Blackpool, Lancashire, United Kingdom, FY3 7EN
    - Furiex research site
  - Thornton-Cleveleys, Lancashire, United Kingdom, FY5 3LF
    - Furiex research site
- Leicestershire
  - Burbage, Leicestershire, United Kingdom, LE10 2SE
    - Furiex research site
- Warwickshire
  - Leamington Spa, Warwickshire, United Kingdom, CV32 4RA
    - Furiex research site
- Wiltshire
  - Chippenham, Wiltshire, United Kingdom, SN14 6GT
    - Furiex research site
United States
- Alabama
  - Athens, Alabama, United States, 35611
    - Furiex research site
  - Birmingham, Alabama, United States, 35213
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  - Foley, Alabama, United States, 36535
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  - Huntsville, Alabama, United States, 35802
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  - Ozark, Alabama, United States, 36360
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- Arizona
  - Chandler, Arizona, United States, 85224
    - Furiex research site
  - Glendale, Arizona, United States, 85306
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  - Mesa, Arizona, United States, 85213
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  - Phoenix, Arizona, United States, 85018
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  - Tucson, Arizona, United States, 85712
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- Arkansas
  - Little Rock, Arkansas, United States, 72211
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  - Little Rock, Arkansas, United States, 72212
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  - North Little Rock, Arkansas, United States, 72117
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- California
  - Azusa, California, United States, 91702
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  - Bell Gardens, California, United States, 90201
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  - Beverly Hills, California, United States, 90211
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  - Carson, California, United States, 91105
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  - Chula Vista, California, United States, 91910
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  - Corona, California, United States, 92880
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  - El Cajon, California, United States, 92020
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  - Encino, California, United States, 91436
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  - Garden Grove, California, United States, 92843
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  - Lomita, California, United States, 90717
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  - Los Angeles, California, United States, 90022
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  - Monterey Park, California, United States, 91754
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  - Murrieta, California, United States, 92562
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  - Newport Beach, California, United States, 92663
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  - North Hollywood, California, United States, 91606
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  - Oakland, California, United States, 94612
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  - Oxnard, California, United States, 93030
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  - Pismo Beach, California, United States, 93449
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  - Poway, California, United States, 92064
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  - Riverside, California, United States, 92501
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  - Roseville, California, United States, 95661
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  - Sacramento, California, United States, 95825
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  - San Diego, California, United States, 92103
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  - San Diego, California, United States, 92114
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  - Santa Monica, California, United States, 90404
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  - Thousand Oaks, California, United States, 91360
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- Colorado
  - Colorado Springs, Colorado, United States, 80904
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  - Colorado Springs, Colorado, United States, 80907
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  - Lafayette, Colorado, United States, 80026
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  - Lakewood, Colorado, United States, 80215
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  - Longmont, Colorado, United States, 80501
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- Connecticut
  - Norwalk, Connecticut, United States, 06851
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  - Ridgefield, Connecticut, United States, 06877
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- Florida
  - Boca Raton, Florida, United States, 33428
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  - Brandon, Florida, United States, 33511
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  - Clearwater, Florida, United States, 33765
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  - Cooper City, Florida, United States, 33024
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  - Coral Springs, Florida, United States, 33065
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  - Crystal River, Florida, United States, 34429
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  - Doral, Florida, United States, 33172
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  - Eustis, Florida, United States, 32726
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  - Hialeah, Florida, United States, 33013
    - Furix Research Site
  - Hialeah, Florida, United States, 33016
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  - Inverness, Florida, United States, 34452
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  - Jacksonville, Florida, United States, 32216
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  - Kissimmee, Florida, United States, 34741
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  - Maitland, Florida, United States, 32751
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  - Melbourne, Florida, United States, 32935
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  - Miami, Florida, United States, 33015
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  - Miami, Florida, United States, 33125
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  - Miami, Florida, United States, 33126
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  - Miami, Florida, United States, 33133
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  - Miami, Florida, United States, 33135
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  - Miami, Florida, United States, 33144
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  - Miami, Florida, United States, 33155
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  - Miami, Florida, United States, 33175
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  - Miami Springs, Florida, United States, 33166
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  - Miramar, Florida, United States, 33025
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  - Naples, Florida, United States, 34102
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  - New Port Richey, Florida, United States, 34653
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  - New Smyrna Beach, Florida, United States, 32168
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  - Orlando, Florida, United States, 32801
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  - Orlando, Florida, United States, 32806
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  - Orlando, Florida, United States, 32819
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  - Ormond Beach, Florida, United States, 32174
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  - Oviedo, Florida, United States, 32765
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  - Palm Beach, Florida, United States, 33472
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  - Pinellas Park, Florida, United States, 33781
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  - Pinellas Park, Florida, United States, 33782
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  - Port Orange, Florida, United States, 32129
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  - Sanford, Florida, United States, 32771
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  - Sebastian, Florida, United States, 32958
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  - South Miami, Florida, United States, 33143
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  - Tampa, Florida, United States, 33606
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  - Tampa, Florida, United States, 33607
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  - Venice, Florida, United States, 34292
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  - Wellington, Florida, United States, 33414
    - Furiex research site
  - Winter Haven, Florida, United States, 33880
    - Furiex research site
  - Winter Park, Florida, United States, 32792
    - Furiex research site
- Georgia
  - Atlanta, Georgia, United States, 30338
    - Furiex research site
  - Blue Ridge, Georgia, United States, 30513
    - Furiex research site
  - Johns Creek, Georgia, United States, 30097
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  - Lilburn, Georgia, United States, 30047
    - Furiex research site
  - Oakwood, Georgia, United States, 30566
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  - Perry, Georgia, United States, 31069
    - Furiex research site
  - Snellville, Georgia, United States, 30078
    - Furiex research site
- Idaho
  - Eagle, Idaho, United States, 83616
    - Furiex research site
- Illinois
  - Addison, Illinois, United States, 60101
    - Furiex research site
  - Chicago, Illinois, United States, 60611
    - Furiex research site
  - Morton, Illinois, United States, 61550
    - Furiex research site
- Indiana
  - Brownsburg, Indiana, United States, 46112
    - Furiex research site
  - Evansville, Indiana, United States, 47714
    - Furiex research site
  - Indianapolis, Indiana, United States, 46202
    - Furiex research site
- Iowa
  - Clive, Iowa, United States, 50325
    - Furiex research site
  - Davenport, Iowa, United States, 52807
    - Furiex research site
  - Iowa City, Iowa, United States, 52242
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  - West Des Moines, Iowa, United States, 50266
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- Kansas
  - Newton, Kansas, United States, 67114
    - Furiex research site
  - Prairie Village, Kansas, United States, 66206
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  - Shawnee Mission, Kansas, United States, 66218
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  - Wichita, Kansas, United States, 67203
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  - Wichita, Kansas, United States, 67205
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- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
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  - Hawesville, Kentucky, United States, 42348
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  - Lexington, Kentucky, United States, 40509
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  - Lexington, Kentucky, United States, 40536
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  - Louisville, Kentucky, United States, 40202
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  - Madisonville, Kentucky, United States, 42431
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  - Owensboro, Kentucky, United States, 42303
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- Louisiana
  - Baker, Louisiana, United States, 70794
    - Furiex research site
  - Covington, Louisiana, United States, 70435
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  - Hammond, Louisiana, United States, 70403
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  - Metairie, Louisiana, United States, 70006
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  - New Orleans, Louisiana, United States, 70124
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  - Opelousas, Louisiana, United States, 70570
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  - Shreveport, Louisiana, United States, 71101
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  - Shreveport, Louisiana, United States, 71105
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- Maine
  - Bangor, Maine, United States, 04401
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- Maryland
  - Annapolis, Maryland, United States, 21401
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  - Chevy Chase, Maryland, United States, 20815
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- Massachusetts
  - Brockton, Massachusetts, United States, 02301
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  - Watertown, Massachusetts, United States, 02472
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- Michigan
  - Ann Arbor, Michigan, United States, 48106
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  - Southfield, Michigan, United States, 48034
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  - Stevensville, Michigan, United States, 49127
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- Minnesota
  - Chaska, Minnesota, United States, 55318
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- Mississippi
  - Jackson, Mississippi, United States, 39202
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- Missouri
  - Jefferson City, Missouri, United States, 65109
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  - Saint Louis, Missouri, United States, 63128
    - Furiex research site
  - Saint Louis, Missouri, United States, 63141
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  - Saint Peters, Missouri, United States, 63376
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- Montana
  - Billings, Montana, United States, 59102
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- Nebraska
  - Bellevue, Nebraska, United States, 68005
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  - Omaha, Nebraska, United States, 68114
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  - Omaha, Nebraska, United States, 68134
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- Nevada
  - Las Vegas, Nevada, United States, 89106
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  - Las Vegas, Nevada, United States, 89119
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- New Jersey
  - Collingswood, New Jersey, United States, 08108
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  - Edison, New Jersey, United States, 08817
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- New Mexico
  - Albuquerque, New Mexico, United States, 87106
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- New York
  - Brooklyn, New York, United States, 11230
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  - Endwell, New York, United States, 13760
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  - Great Neck, New York, United States, 11023
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  - Hartsdale, New York, United States, 10530
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  - Kew Gardens, New York, United States, 11415
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  - New Windsor, New York, United States, 12553
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  - New York, New York, United States, 10016
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  - North Massapequa, New York, United States, 11758
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  - Poughkeepsie, New York, United States, 12601
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- North Carolina
  - Asheville, North Carolina, United States, 28801
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  - Asheville, North Carolina, United States, 28803
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  - Charlotte, North Carolina, United States, 28211
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  - Durham, North Carolina, United States, 27713
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  - Fayetteville, North Carolina, United States, 28304
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  - Greensboro, North Carolina, United States, 27403
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  - Hickory, North Carolina, United States, 28602
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  - High Point, North Carolina, United States, 27262
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  - Kinston, North Carolina, United States, 28501
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  - Lenoir, North Carolina, United States, 28645
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  - Raleigh, North Carolina, United States, 27609
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  - Raleigh, North Carolina, United States, 27612
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  - Salisbury, North Carolina, United States, 28144
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  - Winston-Salem, North Carolina, United States, 27103
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- North Dakota
  - Fargo, North Dakota, United States, 58103
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  - Fargo, North Dakota, United States, 58104
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- Ohio
  - Beavercreek, Ohio, United States, 45432
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  - Berea, Ohio, United States, 44017
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  - Centerville, Ohio, United States, 45459
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  - Cincinnati, Ohio, United States, 45212
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  - Cincinnati, Ohio, United States, 45219
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  - Columbus, Ohio, United States, 43215
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  - Dayton, Ohio, United States, 45415
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  - Dayton, Ohio, United States, 45419
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  - Englewood, Ohio, United States, 45322
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  - Franklin, Ohio, United States, 45005
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  - Marion, Ohio, United States, 43302
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  - Miamisburg, Ohio, United States, 45342
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  - Middleburg Heights, Ohio, United States, 44130
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  - Wadsworth, Ohio, United States, 44281
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  - Zanesville, Ohio, United States, 43701
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- Oklahoma
  - Tulsa, Oklahoma, United States, 74104
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  - Tulsa, Oklahoma, United States, 74135
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  - Tulsa, Oklahoma, United States, 74136
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- Pennsylvania
  - Belle Vernon, Pennsylvania, United States, 15012
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  - Jenkintown, Pennsylvania, United States, 19046
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  - Johnstown, Pennsylvania, United States, 15905
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  - Lansdale, Pennsylvania, United States, 19446
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  - Philadelphia, Pennsylvania, United States, 19142
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  - Philadelphia, Pennsylvania, United States, 19152
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  - Pittsburgh, Pennsylvania, United States, 15236
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  - Pittsburgh, Pennsylvania, United States, 15243
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  - Uniontown, Pennsylvania, United States, 15401
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  - Upper Saint Clair, Pennsylvania, United States, 15241
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- Rhode Island
  - Cumberland, Rhode Island, United States, 02864
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  - East Providence, Rhode Island, United States, 02914
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- South Carolina
  - Anderson, South Carolina, United States, 29621
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  - Charleston, South Carolina, United States, 29406
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  - Fort Mill, South Carolina, United States, 29707
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  - Greenville, South Carolina, United States, 29615
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  - Greer, South Carolina, United States, 29650
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  - Greer, South Carolina, United States, 29651
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  - Myrtle Beach, South Carolina, United States, 29588
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  - Myrtle Beach, South Carolina, United States, 29752
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  - Simpsonville, South Carolina, United States, 29681
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  - Summerville, South Carolina, United States, 29485
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- Tennessee
  - Bristol, Tennessee, United States, 37620
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  - Chattanooga, Tennessee, United States, 37421
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  - Clarksville, Tennessee, United States, 37043
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  - Columbia, Tennessee, United States, 38401
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  - Franklin, Tennessee, United States, 37064
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  - Johnson City, Tennessee, United States, 37604
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  - Memphis, Tennessee, United States, 38119
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  - Smyrna, Tennessee, United States, 37167
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- Texas
  - Austin, Texas, United States, 78745
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  - Austin, Texas, United States, 78756
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  - Baytown, Texas, United States, 77521
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  - Beaumont, Texas, United States, 77701
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  - Dallas, Texas, United States, 75224
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  - El Paso, Texas, United States, 79905
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  - Houston, Texas, United States, 77074
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  - Houston, Texas, United States, 77079
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  - Houston, Texas, United States, 77089
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  - Houston, Texas, United States, 77098
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  - Marshall, Texas, United States, 75670
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  - Plano, Texas, United States, 75024
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  - San Antonio, Texas, United States, 78209
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  - San Antonio, Texas, United States, 78229
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  - San Antonio, Texas, United States, 78258
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  - Sugar Land, Texas, United States, 77478
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- Utah
  - Clinton, Utah, United States, 84015
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  - Draper, Utah, United States, 84020
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  - Logan, Utah, United States, 84341
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  - Ogden, Utah, United States, 84405
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  - Salt Lake City, Utah, United States, 84102
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  - West Jordan, Utah, United States, 84088
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- Virginia
  - Lynchburg, Virginia, United States, 24502
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  - Richmond, Virginia, United States, 23219
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  - Williamsburg, Virginia, United States, 23185
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- Washington
  - Spokane, Washington, United States, 99202
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  - Spokane, Washington, United States, 99204
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  - Spokane, Washington, United States, 99208
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  - Wenatchee, Washington, United States, 98801
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- West Virginia
  - Morgantown, West Virginia, United States, 26505
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- Wisconsin
  - Wauwatosa, Wisconsin, United States, 53226
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
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
  - Participant has nocturnal symptoms
  - Participant has a familial history of first-degree relatives with colon cancer or
  - Participant has blood mixed with their stool (excluding blood from hemorrhoids).
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.

Exclusion Criteria:

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
- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eluxadoline 75 mg Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.	Drug: Eluxadoline Oral tablets twice daily Other Names: JNJ-27018966
Experimental: Eluxadoline 100 mg Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.	Drug: Eluxadoline Oral tablets twice daily Other Names: JNJ-27018966
Placebo Comparator: Placebo Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.	Drug: Placebo Oral tablets twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Composite responders were defined as a participant 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.	Up to 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 26 Weeks	Composite responders were defined as a participant 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.	Up to 26 Weeks
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals Time Frame: 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)	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.	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)
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals Time Frame: 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)	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.	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)
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals Time Frame: 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)	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.	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)
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale Time Frame: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])	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.	Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])
Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale Time Frame: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)	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.	12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
Change From Baseline in Daily Abdominal Discomfort Scores Time Frame: Baseline, Weeks 4, 12 and 26	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.	Baseline, Weeks 4, 12 and 26
Change From Baseline in Daily Abdominal Bloating Scores Time Frame: Baseline, Weeks 4, 12 and 26	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.	Baseline, Weeks 4, 12 and 26
Number of Bowel Movements Per Day Time Frame: Weeks 4, 12 and 26	Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.	Weeks 4, 12 and 26
Number of Bowel Incontinence Episodes Time Frame: Weeks 4, 12 and 26	Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.	Weeks 4, 12 and 26
Number of Bowel Incontinence Free Days Time Frame: Weeks 4, 12 and 26	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.	Weeks 4, 12 and 26
Number of Urgency Episodes Per Day Time Frame: Weeks 4, 12 and 26	Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.	Weeks 4, 12 and 26
IBS-QoL Total Scores Time Frame: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)	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.	Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)
Change From Baseline in IBS-QoL Total Scores Time Frame: Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT	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.	Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Furiex Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2012

Primary Completion (Actual)

July 29, 2014

Study Completion (Actual)

July 29, 2014

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

27018966IBS3001
2012-001600-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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More Information

Terms related to this study

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Clinical Trials on Irritable Bowel Syndrome

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