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

Sponsor
Furiex Pharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01130272
Collaborator
(none)
807
Enrollment
288
Locations
5
Arms
14.5
Actual Duration (Months)
2.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
807 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 28, 2010
Actual Primary Completion Date :
Jul 14, 2011
Actual Study Completion Date :
Jul 14, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eluxadoline 5 mg

Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.

Drug: Eluxadoline
Tablets, orally, twice daily.
Other Names:
  • JNJ-27018966

    		•
    Experimental: Eluxadoline 25 mg

    Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .

    Drug: Eluxadoline
    Tablets, orally, twice daily.
    Other Names:
  • JNJ-27018966

    		•
    Experimental: Eluxadoline 100 mg

    Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.

    Drug: Eluxadoline
    Tablets, orally, twice daily.
    Other Names:
  • JNJ-27018966

    		•
    Experimental: Eluxadoline 200 mg

    Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.

    Drug: Eluxadoline
    Tablets, orally, twice daily.
    Other Names:
  • JNJ-27018966

    		•
    Placebo Comparator: Placebo

    Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.

    Drug: Placebo
    Matching placebo oral tablets twice daily.

    Outcome Measures

    Primary Outcome Measures

    1. 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 [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.

    2. 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 [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.

    Secondary Outcome Measures

    1. Change From Baseline in the Weekly Pain Scores [Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12]

      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.

    2. Change From Baseline in Weekly BSS Scores [Baseline (Week prior to Randomization) to Weeks 4, 8, and 12]

      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.

    3. Change From Baseline in the Number of Daily Bowel Movements [Baseline (Week prior to Randomization) to Weeks 4, 8, and 12]

      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.

    4. Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time [Baseline (Week Prior to Randomization) to Weeks 1-12]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • 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.

    Key Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Furiex Research Site Anniston Alabama United States 36207
    2 Furiex Research Site Birmingham Alabama United States 35216
    3 Furiex Research Site Birmingham Alabama United States 35235
    4 Furiex Research Site Dothan Alabama United States 36305
    5 Furiex Research Site Huntsville Alabama United States 35801
    6 Furiex Research Site Huntsville Alabama United States 35802
    7 Furiex Research Site Mobile Alabama United States 36693
    8 Furiex Research Site Montgomery Alabama United States 36109
    9 Furiex Research Site Pell City Alabama United States 35128
    10 Furiex Research Site Chandler Arizona United States 85224
    11 Furiex Research Site Glendale Arizona United States 85308
    12 Furiex Research Site Mesa Arizona United States 85203
    13 Furiex Research Site Phoenix Arizona United States 85018
    14 Furiex Research Site Phoenix Arizona United States 85020
    15 Furiex Research Site Phoenix Arizona United States 85050
    16 Furiex Research Site Tempe Arizona United States 85282
    17 Furiex Research Site Tempe Arizona United States 85283
    18 Furiex Research Site Tucson Arizona United States 85704
    19 Furiex Research Site Tucson Arizona United States 85710
    20 Furiex Research Site Jonesboro Arkansas United States 72401
    21 Furiex Research Site Little Rock Arkansas United States 72211
    22 Furiex Research Site Searcy Arkansas United States 72143
    23 Furiex Research Site Sherwood Arkansas United States 72120
    24 Furiex Research Site Aliso Viejo California United States 92656
    25 Furiex Research Site Anaheim California United States 92801
    26 Furiex Research Site Azusa California United States 91702
    27 Furiex Research Site Burbank California United States 91505
    28 Furiex Research Site Carlsbad California United States 92008
    29 Furiex Research Site Encinitas California United States 92024
    30 Furiex Research Site Garden Grove California United States 92840
    31 Furiex Research Site Garden Grove California United States 92843
    32 Furiex Research Site Inglewood California United States 90301
    33 Furiex Research Site Laguna Hills California United States 92653
    34 Furiex Research Site Long Beach California United States 90806
    35 Furiex Research Site Los Angeles California United States 90015
    36 Furiex Research Site Los Angeles California United States 90045
    37 Furiex Research Site Murietta California United States 92562
    38 Furiex Research Site Oakland California United States 94609
    39 Furiex Research Site Orange California United States 92869
    40 Furiex Research Site Sacramento California United States 95825
    41 Furiex Research Site San Carlos California United States 94070
    42 Furiex Research Site San Diego California United States 92103-6204
    43 Furiex Research Site San Diego California United States 92120
    44 Furiex Research Site Colorado Springs Colorado United States 80904
    45 Furiex Research Site Colorado Springs Colorado United States 80907
    46 Furiex Research Site Colorado Springs Colorado United States 80920
    47 Furiex Research Site Colorado Springs Colorado United States 80922
    48 Furiex Research Site Denver Colorado United States 80222
    49 Furiex Research Site Denver Colorado United States 80239
    50 Furiex Research Site Lakewood Colorado United States 80215
    51 Furiex Research Site Littleton Colorado United States 80120
    52 Furiex Research Site Thornton Colorado United States 80229
    53 Furiex Research Site Bristol Connecticut United States 06010
    54 Furiex Research Site Waterbury Connecticut United States 06708
    55 Furiex Research Site Aventura Florida United States 33916
    56 Furiex Research Site Boca Raton Florida United States 33428
    57 Furiex Research Site Boca Raton Florida United States 33432
    58 Furiex Research Site Bradenton Florida United States 34208
    59 Furiex Research Site Brandon Florida United States 33511
    60 Furiex Research Site Chipley Florida United States 32428
    61 Furiex Research Site DeLand Florida United States 32720
    62 Furiex Research Site Delray Beach Florida United States 33484
    63 Furiex Research Site Doral Florida United States 33172
    64 Furiex Research Site Fort Lauderdale Florida United States 33306
    65 Furiex Research Site Hialeah Florida United States 33013
    66 Furiex Research Site Hialeah Florida United States 33016
    67 Furiex Research Site Inverness Florida United States 34452
    68 Furiex Research Site Jacksonville Florida United States 32209
    69 Furiex Research Site Jacksonville Florida United States 32256
    70 Furiex Research Site Jupiter Florida United States 33458
    71 Furiex Research Site Kissimmee Florida United States 34741
    72 Furiex Research Site Largo Florida United States 33777
    73 Furiex Research Site Lauderdale Lakes Florida United States 33319
    74 Furiex Research Site Melbourne Florida United States 32935
    75 Furiex Research Site Miami Florida United States 33126
    76 Furiex Research Site Miami Florida United States 33135
    77 Furiex Research Site Miami Florida United States 33155
    78 Furiex Research Site Naples Florida United States 34102
    79 Furiex Research Site Naples Florida United States 34109
    80 Furiex Research Site New Port Richey Florida United States 34652
    81 Furiex Research Site New Port Richey Florida United States 34655
    82 Furiex Research Site New Smyrna Beach Florida United States 32168
    83 Furiex Research Site Orlando Florida United States 32837
    84 Furiex Research Site Plantation Florida United States 33317
    85 Furiex Research Site Port Orange Florida United States 32129
    86 Furiex Research Site Saint Petersburg Florida United States 33709
    87 Furiex Research Site South Miami Florida United States 33143
    88 Furiex Research Site Tampa Florida United States 33606
    89 Furiex Research Site Tampa Florida United States 33613
    90 Furiex Research Site Atlanta Georgia United States 30312
    91 Furiex Research Site Atlanta Georgia United States 30338
    92 Furiex Research Site Columbus Georgia United States 31904
    93 Furiex Research Site Duluth Georgia United States 30096
    94 Furiex Research Site Macon Georgia United States 31201
    95 Furiex Research Site Marietta Georgia United States 30066
    96 Furiex Research Site Newnan Georgia United States 30263
    97 Furiex Research Site Rome Georgia United States 30165
    98 Furiex Research Site Sandy Springs Georgia United States 30328
    99 Furiex Research Site Savannah Georgia United States 31406
    100 Furiex Research Site Boise Idaho United States 83702
    101 Furiex Research Site Boise Idaho United States 83704
    102 Furiex Research Site Idaho Falls Idaho United States 83404
    103 Furiex Research Site Meridian Idaho United States 83642
    104 Furiex Research Site Nampa Idaho United States 83686
    105 Furiex Research Site Champaign Illinois United States 61820
    106 Furiex Research Site Chicago Illinois United States 60634
    107 Furiex Research Site Morton Illinois United States 61550
    108 Furiex Research Site Anderson Indiana United States 46016
    109 Furiex Research Site Bloomington Indiana United States 47403
    110 Furiex Research Site Evansville Indiana United States 47714
    111 Furiex Research Site Indianapolis Indiana United States 46205
    112 Furiex Research Site Indianapolis Indiana United States 46237
    113 Furiex Research Site Indianapolis Indiana United States 46250
    114 Furiex Research Site Lenexa Kansas United States 66215
    115 Furiex Research Site Mission Kansas United States 66202
    116 Furiex Research Site Overland Park Kansas United States 66202
    117 Furiex Research Site Overland Park Kansas United States 66215
    118 Furiex Research Site Topeka Kansas United States 66606
    119 Furiex Research Site Wichita Kansas United States 67203
    120 Furiex Research Site Bowling Green Kentucky United States 42101
    121 Furiex Research Site Lexington Kentucky United States 40504
    122 Furiex Research Site Louisville Kentucky United States 40202
    123 Furiex Research Site Metairie Louisiana United States 70006
    124 Furiex Research Site Monroe Louisiana United States 71201
    125 Furiex Research Site Opelousas Louisiana United States 70570
    126 Furiex Research Site Shreveport Louisiana United States 71101
    127 Furiex Research Site Shreveport Louisiana United States 71103
    128 Furiex Research Site Annapolis Maryland United States 21401
    129 Furiex Research Site Chevy Chase Maryland United States 20815
    130 Furiex Research Site Hollywood Maryland United States 20636
    131 Furiex Research Site Laurel Maryland United States 20707
    132 Furiex Research Site Lutherville Maryland United States 21093
    133 Furiex Research Site Prince Frederick Maryland United States 20678
    134 Furiex Research Site Rockville Maryland United States 20850
    135 Furiex Research Site Boston Massachusetts United States 02114
    136 Furiex Research Site Boston Massachusetts United States 02135
    137 Furiex Research Site Boston Massachusetts United States 02215
    138 Furiex Research Site Brockton Massachusetts United States 02301
    139 Furiex Research Site Hyannis Massachusetts United States 02601
    140 Furiex Research Site Springfield Massachusetts United States 01105
    141 Furiex Research Site Chesterfield Michigan United States 48047
    142 Furiex Research Site Interlochen Michigan United States 49643
    143 Furiex Research Site Kalamazoo Michigan United States 49009
    144 Furiex Research Site Novi Michigan United States 48377
    145 Furiex Research Site Troy Michigan United States 48098
    146 Furiex Research Site Chaska Minnesota United States 55318
    147 Furiex Research Site Jackson Mississippi United States 39202
    148 Furiex Research Site Tupelo Mississippi United States 38801
    149 Furiex Research Site Mexico Missouri United States 65265
    150 Furiex Research Site Saint Louis Missouri United States 63141
    151 Furiex Research Site Saint Peters Missouri United States 63376
    152 Furiex Research Site Billings Montana United States 59102
    153 Furiex Research Site Bozeman Montana United States 59718
    154 Furiex Research Site Bellevue Nebraska United States 68005
    155 Furiex Research Site Omaha Nebraska United States 68114
    156 Furiex Research Site Omaha Nebraska United States 68144
    157 Furiex Research Site Henderson Nevada United States 89052
    158 Furiex Research Site Las Vegas Nevada United States 89106
    159 Furiex Research Site Las Vegas Nevada United States 89183
    160 Furiex Research Site Atco New Jersey United States 08044
    161 Furiex Research Site Blackwood New Jersey United States 08012
    162 Furiex Research Site Elizabeth New Jersey United States 07202
    163 Furiex Research Site Marlton New Jersey United States 08053
    164 Furiex Research Site Morristown New Jersey United States 07960
    165 Furiex Research Site South Bound Brook New Jersey United States 08880
    166 Furiex Research Site Vineland New Jersey United States 08360
    167 Furiex Research Site Albuquerque New Mexico United States 87102
    168 Furiex Research Site Albuquerque New Mexico United States 87108
    169 Furiex Research Site Binghamton New York United States 13903
    170 Furiex Research Site Brooklyn New York United States 11214
    171 Furiex Research Site Brooklyn New York United States 11230
    172 Furiex Research Site Great Neck New York United States 11021
    173 Furiex Research Site Great Neck New York United States 11023
    174 Furiex Research Site Mineola New York United States 11501
    175 Furiex Research Site New York New York United States 10016
    176 Furiex Research Site Boone North Carolina United States 28607
    177 Furiex Research Site Chapel Hill North Carolina United States 27599
    178 Furiex Research Site Charlotte North Carolina United States 28209
    179 Furiex Research Site Charlotte North Carolina United States 28277
    180 Furiex Research Site Fayetteville North Carolina United States 28304
    181 Furiex Research Site Greensboro North Carolina United States 27401
    182 Furiex Research Site Greensboro North Carolina United States 27403
    183 Furiex Research Site Greenville North Carolina United States 27834
    184 Furiex Research Site Harrisburg North Carolina United States 28075
    185 Furiex Research Site Hickory North Carolina United States 28601
    186 Furiex Research Site Hickory North Carolina United States 28602
    187 Furiex Research Site High Point North Carolina United States 27262
    188 Furiex Research Site Jacksonville North Carolina United States 28546
    189 Furiex Research Site New Bern North Carolina United States 28562
    190 Furiex Research Site Raleigh North Carolina United States 27609
    191 Furiex Research Site Raleigh North Carolina United States 27612
    192 Furiex Research Site Wilmington North Carolina United States 28401
    193 Furiex Research Site Winston-Salem North Carolina United States 27103-3914
    194 Furiex Research Site Winston-Salem North Carolina United States 27103
    195 Furiex Research Site Fargo North Dakota United States 58103
    196 Furiex Research Site Fargo North Dakota United States 58104
    197 Furiex Research Site Akron Ohio United States 44302
    198 Furiex Research Site Beachwood Ohio United States 44122
    199 Furiex Research Site Beavercreek Ohio United States 45432
    200 Furiex Research Site Cincinnati Ohio United States 45229
    201 Furiex Research Site Cleveland Ohio United States 44122
    202 Furiex Research Site Columbus Ohio United States 43214
    203 Furiex Research Site Columbus Ohio United States 43215
    204 Furiex Research Site Dayton Ohio United States 45432
    205 Furiex Research Site Franklin Ohio United States 45005
    206 Furiex Research Site Mentor Ohio United States 44060
    207 Furiex Research Site Miamisburg Ohio United States 45342-3705
    208 Furiex Research Site Springfield Ohio United States 45504
    209 Furiex Research Site Wadsworth Ohio United States 44281
    210 Furiex Research Site Norman Oklahoma United States 73069
    211 Furiex Research Site Norman Oklahoma United States 73071
    212 Furiex Research Site Oklahoma City Oklahoma United States 73104
    213 Furiex Research Site Oklahoma City Oklahoma United States 73112
    214 Furiex Research Site Yukon Oklahoma United States 73099
    215 Furiex Research Site Dingmans Ferry Pennsylvania United States 18328
    216 Furiex Research Site Hermitage Pennsylvania United States 16148
    217 Furiex Research Site Jenkintown Pennsylvania United States 19046
    218 Furiex Research Site Lancaster Pennsylvania United States 17604
    219 Furiex Research Site Lansdale Pennsylvania United States 19446
    220 Furiex Research Site Newton Pennsylvania United States 18940
    221 Furiex Research Site Sayre Pennsylvania United States 18840
    222 Furiex Research Site Uniontown Pennsylvania United States 15401
    223 Furiex Research Site Washington Pennsylvania United States 15301
    224 Furiex Research Site Cumberland Rhode Island United States 02864
    225 Furiex Research Site East Providence Rhode Island United States 02914
    226 Furiex Research Site Warwick Rhode Island United States 02886
    227 Furiex Research Site Anderson South Carolina United States 29621
    228 Furiex Research Site Columbia South Carolina United States 29201
    229 Furiex Research Site Columbia South Carolina United States 29203
    230 Furiex Research Site Greer South Carolina United States 29651
    231 Furiex Research Site Mount Pleasant South Carolina United States 29464
    232 Furiex Research Site Rapid City South Dakota United States 57702
    233 Furiex Research Site Bristol Tennessee United States 37620
    234 Furiex Research Site Chattanooga Tennessee United States 37404
    235 Furiex Research Site Chattanooga Tennessee United States 37421
    236 Furiex Research Site Germantown Tennessee United States 38138
    237 Furiex Research Site Jackson Tennessee United States 38301
    238 Furiex Research Site Johnson City Tennessee United States 37604
    239 Furiex Research Site Kingsport Tennessee United States 37660
    240 Furiex Research Site Nashville Tennessee United States 37203
    241 Furiex Research Site Nashville Tennessee United States 37205
    242 Furiex Research Site Austin Texas United States 78705
    243 Furiex Research Site Bedford Texas United States 76022
    244 Furiex Research Site Colleyville Texas United States 76034
    245 Furiex Research Site El Paso Texas United States 79902
    246 Furiex Research Site Fort Worth Texas United States 76107
    247 Furiex Research Site Fort Worth Texas United States 76108
    248 Furiex Research Site Grand Prairie Texas United States 75052
    249 Furiex Research Site Grapevine Texas United States 76051
    250 Furiex Research Site Houston Texas United States 77005
    251 Furiex Research Site Houston Texas United States 77022
    252 Furiex Research Site Houston Texas United States 77030
    253 Furiex Research Site Houston Texas United States 77034
    254 Furiex Research Site Houston Texas United States 77074
    255 Furiex Research Site Houston Texas United States 77081
    256 Furiex Research Site Houston Texas United States 77090
    257 Furiex Research Site Houston Texas United States 77505
    258 Furiex Research Site Hurst Texas United States 76054
    259 Furiex Research Site Irving Texas United States 75061
    260 Furiex Research Site Lake Jackson Texas United States 77566
    261 Furiex Research Site Marshall Texas United States 75670
    262 Furiex Research Site North Richland Hills Texas United States 76180
    263 Furiex Research Site Odessa Texas United States 79761
    264 Furiex Research Site Plano Texas United States 75074
    265 Furiex Research Site San Antonio Texas United States 78209
    266 Furiex Research Site San Antonio Texas United States 78212
    267 Furiex Research Site San Antonio Texas United States 78215
    268 Furiex Research Site San Antonio Texas United States 78229
    269 Furiex Research Site San Antonio Texas United States 78258
    270 Furiex Research Site Sugar Land Texas United States 77478
    271 Furiex Research Site Sugar Land Texas United States 77479
    272 Furiex Research Site Webster Texas United States 77598
    273 Furiex Research Site Logan Utah United States 84341
    274 Furiex Research Site Ogden Utah United States 84405
    275 Furiex Research Site Salt Lake City Utah United States 84109
    276 Furiex Research Site Salt Lake City Utah United States 84121
    277 Furiex Research Site South Jordan Utah United States 84095
    278 Furiex Research Site West Jordan Utah United States 84088
    279 Furiex Research Site West Valley City Utah United States 84120
    280 Furiex Research Site Alexandria Virginia United States 22304
    281 Furiex Research Site Chesapeake Virginia United States 23320
    282 Furiex Research Site Christiansburg Virginia United States 24073
    283 Furiex Research Site Danville Virginia United States 24541
    284 Furiex Research Site Fairfax Virginia United States 22031
    285 Furiex Research Site Virginia Beach Virginia United States 23455
    286 Furiex Research Site Mill Creek Washington United States 98012-6316
    287 Furiex Research Site Madison Wisconsin United States 53715
    288 Furiex Research Site Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Furiex Pharmaceuticals, Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Furiex Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT01130272
    Other Study ID Numbers:
    • 27018966IBS2001
    First Posted:
    May 25, 2010
    Last Update Posted:
    Oct 22, 2019
    Last Verified:
    Sep 1, 2019
    Keywords provided by Furiex Pharmaceuticals, Inc
    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
    Additional relevant MeSH terms:
    Irritable Bowel Syndrome
    Syndrome
    Diarrhea
    Eluxadoline

    Study Results

    Participant Flow

    Recruitment Details 9 patients were randomized more than once, enrolling at a second (or third) site after discontinuation from the first site. Safety data was analyzed according to the highest dose received. Safety Analysis Set: Highest Dose Level in the Participant Flow reflects the reassignment of patients randomized more than once to the highest dose level arm.
    Pre-assignment Detail 807 patients were randomized in the trial. 18 of these patients were enrolled at a site terminated by Furiex, reported to the FDA for potential scientific misconduct, and were excluded from all datasets. All Randomized Patients=789 patients.
    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Period Title: Overall Study
    STARTED 107 173 169 171 169
    Safety Analysis Set: as Randomized 105 171 166 167 162
    Safety Analysis Set: Highest Dose Level 105 170 165 172 159
    COMPLETED 48 131 121 103 117
    NOT COMPLETED 59 42 48 68 52

    Baseline Characteristics

    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo Total
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks. Total of all reporting groups
    Overall Participants 107 173 169 171 169 789
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    45.4
    (13.00)
    45.5
    (11.91)
    43.6
    (10.89)
    45.0
    (11.65)
    44.5
    (12.31)
    44.8
    (11.88)
    Age, Customized (Number) [Number]
    18 to 25 years
    13
    12.1%
    11
    6.4%
    11
    6.5%
    10
    5.8%
    11
    6.5%
    56
    7.1%
    26 to 35 years
    14
    13.1%
    33
    19.1%
    31
    18.3%
    32
    18.7%
    35
    20.7%
    145
    18.4%
    36 to 45 years
    21
    19.6%
    33
    19.1%
    45
    26.6%
    37
    21.6%
    33
    19.5%
    169
    21.4%
    46 to 55 years
    29
    27.1%
    54
    31.2%
    58
    34.3%
    60
    35.1%
    52
    30.8%
    253
    32.1%
    56 to 65 years
    30
    28%
    42
    24.3%
    24
    14.2%
    32
    18.7%
    38
    22.5%
    166
    21%
    Sex: Female, Male (Count of Participants)
    Female
    76
    71%
    120
    69.4%
    117
    69.2%
    119
    69.6%
    118
    69.8%
    550
    69.7%
    Male
    31
    29%
    53
    30.6%
    52
    30.8%
    52
    30.4%
    51
    30.2%
    239
    30.3%
    Race/Ethnicity, Customized (Number) [Number]
    White
    90
    84.1%
    144
    83.2%
    145
    85.8%
    147
    86%
    150
    88.8%
    676
    85.7%
    Black or African American
    12
    11.2%
    21
    12.1%
    18
    10.7%
    18
    10.5%
    17
    10.1%
    86
    10.9%
    Asian
    3
    2.8%
    4
    2.3%
    3
    1.8%
    4
    2.3%
    2
    1.2%
    16
    2%
    American Indian or Alaska Native
    1
    0.9%
    2
    1.2%
    0
    0%
    0
    0%
    0
    0%
    3
    0.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Other
    1
    0.9%
    2
    1.2%
    3
    1.8%
    2
    1.2%
    0
    0%
    8
    1%
    Race/Ethnicity, Customized (Number) [Number]
    Hispanic or Latino
    13
    12.1%
    31
    17.9%
    32
    18.9%
    22
    12.9%
    24
    14.2%
    122
    15.5%
    Not Hispanic or Latino
    94
    87.9%
    142
    82.1%
    137
    81.1%
    149
    87.1%
    145
    85.8%
    667
    84.5%
    Height (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    167.05
    (9.807)
    166.26
    (9.523)
    168.38
    (9.941)
    167.82
    (9.201)
    167.40
    (9.725)
    167.40
    (9.632)
    Weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    89.10
    (23.027)
    83.95
    (23.657)
    86.04
    (23.796)
    86.53
    (21.584)
    86.28
    (21.246)
    86.15
    (22.671)
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    31.88
    (7.739)
    30.41
    (8.398)
    30.16
    (7.059)
    30.71
    (7.290)
    30.81
    (7.443)
    30.71
    (7.595)

    Outcome Measures

    1. Primary Outcome
    Title 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
    Description 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.
    Time Frame Baseline (Week prior to Randomization) to Week 4

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Measure Participants 105 167 163 160 159
    Number [percentage of participants]
    12.4
    11.6%
    12.0
    6.9%
    11.0
    6.5%
    13.8
    8.1%
    5.7
    3.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 5 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.052
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.457
    Confidence Interval (2-Sided) 95%
    0.994 to 6.077
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 25 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.041
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.383
    Confidence Interval (2-Sided) 95%
    1.036 to 5.478
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 100 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.090
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.079
    Confidence Interval (2-Sided) 95%
    0.893 to 4.842
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 200 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.797
    Confidence Interval (2-Sided) 95%
    1.227 to 6.376
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title 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
    Description 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.
    Time Frame Baseline (Week prior to Randomization) to Week 12

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Measure Participants 105 167 163 160 159
    Number [percentage of participants]
    8.6
    8%
    13.2
    7.6%
    20.2
    12%
    15.0
    8.8%
    11.3
    6.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 5 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.449
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.719
    Confidence Interval (2-Sided) 95%
    0.306 to 1.689
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 25 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.583
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.208
    Confidence Interval (2-Sided) 95%
    0.615 to 2.373
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 100 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.030
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.014
    Confidence Interval (2-Sided) 95%
    1.069 to 3.795
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Eluxadoline 200 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.326
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.395
    Confidence Interval (2-Sided) 95%
    0.717 to 2.716
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in the Weekly Pain Scores
    Description 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.
    Time Frame Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    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. Number analyzed is the number of participants with data available at the given time-point.
    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Measure Participants 105 167 163 160 159
    Baseline
    5.75
    (1.541)
    5.91
    (1.699)
    6.11
    (1.723)
    5.78
    (1.477)
    5.87
    (1.671)
    Change from Baseline to Week 4
    -1.76
    (1.964)
    -2.11
    (1.922)
    -2.33
    (1.945)
    -2.20
    (1.874)
    -2.09
    (2.085)
    Change from Baseline to Week 8
    -2.35
    (2.105)
    -2.54
    (2.200)
    -2.81
    (1.973)
    -2.58
    (2.099)
    -2.54
    (2.330)
    Change from Baseline to Week 12
    -2.50
    (1.979)
    -2.57
    (2.220)
    -3.25
    (2.115)
    -2.96
    (2.138)
    -2.65
    (2.339)
    4. Secondary Outcome
    Title Change From Baseline in Weekly BSS Scores
    Description 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.
    Time Frame Baseline (Week prior to Randomization) to Weeks 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    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. Number analyzed is the number of participants with data available at the given time-point.
    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Measure Participants 105 167 163 160 159
    Baseline
    6.19
    (0.445)
    6.24
    (0.404)
    6.22
    (0.429)
    6.23
    (0.420)
    6.20
    (0.439)
    Change from Baseline to Week 4
    -1.09
    (1.095)
    -1.17
    (1.116)
    -1.48
    (1.326)
    -1.66
    (1.266)
    -0.99
    (1.179)
    Change from Baseline to Week 8
    -1.19
    (1.125)
    -1.39
    (1.193)
    -1.64
    (1.331)
    -1.71
    (1.373)
    -1.19
    (1.185)
    Change from Baseline to Week 12
    -1.37
    (1.206)
    -1.41
    (1.225)
    -1.68
    (1.296)
    -1.89
    (1.317)
    -1.27
    (1.281)
    5. Secondary Outcome
    Title Change From Baseline in the Number of Daily Bowel Movements
    Description 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.
    Time Frame Baseline (Week prior to Randomization) to Weeks 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    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. Number analyzed is the number of participants with data available at the given time-point.
    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Measure Participants 105 167 163 160 159
    Baseline
    4.55
    (2.474)
    4.43
    (3.155)
    5.13
    (3.590)
    4.99
    (3.206)
    4.91
    (3.567)
    Change from Baseline to Week 4
    -1.14
    (1.702)
    -1.19
    (1.673)
    -1.71
    (1.989)
    -2.03
    (2.519)
    -1.39
    (3.096)
    Change from Baseline to Week 8
    -1.40
    (2.093)
    -1.31
    (1.607)
    -1.85
    (1.944)
    -2.20
    (2.927)
    -1.65
    (3.423)
    Change from Baseline to Week 12
    -1.59
    (2.413)
    -1.38
    (1.727)
    -2.13
    (2.139)
    -2.29
    (2.857)
    -1.71
    (3.599)
    6. Secondary Outcome
    Title Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time
    Description 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.
    Time Frame Baseline (Week Prior to Randomization) to Weeks 1-12

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set; Subjects were included in the interval of Weeks 1-4, Weeks 5-8, or Weeks 9-12 if they received at least 1 dose of study medication within that interval.
    Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo
    Arm/Group Description Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Measure Participants 105 167 163 160 159
    Weeks 1-12
    16.5
    15.4%
    20.2
    11.7%
    29.7
    17.6%
    30.6
    17.9%
    19.0
    11.2%
    Weeks 1-4
    18.0
    16.8%
    21.0
    12.1%
    24.9
    14.7%
    32.7
    19.1%
    20.0
    11.8%
    Weeks 5-8
    29.3
    27.4%
    34.4
    19.9%
    43.0
    25.4%
    39.3
    23%
    30.3
    17.9%
    Weeks 9-12
    29.7
    27.8%
    34.4
    19.9%
    49.1
    29.1%
    50.7
    29.6%
    31.0
    18.3%

    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)
    Adverse Event Reporting Description Safety population: all patients enrolled who received at least 1 dose of study drug. Nine patients were identified as having been randomized more than once in the study, enrolling at a second (or third) site after discontinuation from the first site. All available data for each patient was included in the Safety Analysis Set and was analyzed according to the highest dose level of treatment received.
    Arm/Group Title Placebo Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg
    Arm/Group Description Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks. Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
    All Cause Mortality
    Placebo Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/159 (0.6%) 1/105 (1%) 3/170 (1.8%) 1/165 (0.6%) 3/172 (1.7%)
    Gastrointestinal disorders
    Pancreatitis 0/159 (0%) 0/105 (0%) 1/170 (0.6%) 0/165 (0%) 0/172 (0%)
    Alcoholic pancreatitis 0/159 (0%) 0/105 (0%) 0/170 (0%) 0/165 (0%) 1/172 (0.6%)
    Pancreatitis acute 0/159 (0%) 0/105 (0%) 0/170 (0%) 1/165 (0.6%) 1/172 (0.6%)
    Appendicitis perforated 0/159 (0%) 0/105 (0%) 0/170 (0%) 0/165 (0%) 1/172 (0.6%)
    General disorders
    Noncardiac chest pain 0/159 (0%) 1/105 (1%) 0/170 (0%) 0/165 (0%) 0/172 (0%)
    Infections and infestations
    Pneumonia 0/159 (0%) 0/105 (0%) 1/170 (0.6%) 0/165 (0%) 0/172 (0%)
    Psychiatric disorders
    Anxiety 1/159 (0.6%) 0/105 (0%) 0/170 (0%) 0/165 (0%) 0/172 (0%)
    Depression 1/159 (0.6%) 0/105 (0%) 0/170 (0%) 0/165 (0%) 0/172 (0%)
    Major depression 0/159 (0%) 0/105 (0%) 1/170 (0.6%) 0/165 (0%) 0/172 (0%)
    Affective disorder 0/159 (0%) 0/105 (0%) 1/170 (0.6%) 0/165 (0%) 0/172 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 25/159 (15.7%) 20/105 (19%) 34/170 (20%) 27/165 (16.4%) 43/172 (25%)
    Gastrointestinal disorders
    Nausea 7/159 (4.4%) 6/105 (5.7%) 11/170 (6.5%) 9/165 (5.5%) 18/172 (10.5%)
    Abdominal pain 3/159 (1.9%) 3/105 (2.9%) 6/170 (3.5%) 4/165 (2.4%) 13/172 (7.6%)
    Vomiting 1/159 (0.6%) 1/105 (1%) 7/170 (4.1%) 7/165 (4.2%) 12/172 (7%)
    Constipation 4/159 (2.5%) 2/105 (1.9%) 5/170 (2.9%) 10/165 (6.1%) 6/172 (3.5%)
    Infections and infestations
    Sinusitis 9/159 (5.7%) 5/105 (4.8%) 4/170 (2.4%) 3/165 (1.8%) 1/172 (0.6%)
    Nervous system disorders
    Dizziness 4/159 (2.5%) 4/105 (3.8%) 4/170 (2.4%) 5/165 (3%) 11/172 (6.4%)
    Headache 6/159 (3.8%) 3/105 (2.9%) 12/170 (7.1%) 5/165 (3%) 7/172 (4.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

    Results Point of Contact

    Name/Title Therapeutic Area Head
    Organization Allergan
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Furiex Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT01130272
    Other Study ID Numbers:
    • 27018966IBS2001
    First Posted:
    May 25, 2010
    Last Update Posted:
    Oct 22, 2019
    Last Verified:
    Sep 1, 2019