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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01553591
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : September 4, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome
Interventions Drug: Eluxadoline
Drug: Placebo
Enrollment 1282
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Period Title: Overall Study
Started 429 426 427
Attended Week 12 Visit 341 330 342
Attended Week 26 Visit 289 291 290
Completed 257 257 269
Not Completed 172 169 158
Reason Not Completed
Voluntarily withdrew             94             79             96
Adverse Event             36             45             16
Lost to Follow-up             25             23             16
Physician decision: other             11             14             16
Physician decision: lack of efficacy             2             3             7
Protocol Violation             3             4             4
Sponsor decision             1             0             3
Randomized and never dispensed drug             0             1             0
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo Total
Hide Arm/Group Description Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period. Total of all reporting groups
Overall Number of Baseline Participants 429 426 427 1282
Hide Baseline Analysis Population Description
Enrolled Set included 1282 participants who were randomized or received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 429 participants 426 participants 427 participants 1282 participants
44.5  (13.18) 44.4  (13.91) 45.8  (14.10) 44.9  (13.74)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
18-40 years Number Analyzed 429 participants 426 participants 427 participants 1282 participants
173
  40.3%
166
  39.0%
159
  37.2%
498
  38.8%
41-64 years Number Analyzed 429 participants 426 participants 427 participants 1282 participants
227
  52.9%
225
  52.8%
217
  50.8%
669
  52.2%
≥65 years Number Analyzed 429 participants 426 participants 427 participants 1282 participants
29
   6.8%
35
   8.2%
51
  11.9%
115
   9.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 429 participants 426 participants 427 participants 1282 participants
Female
278
  64.8%
283
  66.4%
277
  64.9%
838
  65.4%
Male
151
  35.2%
143
  33.6%
150
  35.1%
444
  34.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 429 participants 426 participants 427 participants 1282 participants
374
  87.2%
368
  86.4%
370
  86.7%
1112
  86.7%
Black Number Analyzed 429 participants 426 participants 427 participants 1282 participants
46
  10.7%
48
  11.3%
46
  10.8%
140
  10.9%
Asian Number Analyzed 429 participants 426 participants 427 participants 1282 participants
3
   0.7%
3
   0.7%
4
   0.9%
10
   0.8%
American Indian or Alaska Native Number Analyzed 429 participants 426 participants 427 participants 1282 participants
1
   0.2%
2
   0.5%
1
   0.2%
4
   0.3%
Native Hawaiian or Other Pacific Islander Number Analyzed 429 participants 426 participants 427 participants 1282 participants
0
   0.0%
1
   0.2%
0
   0.0%
1
   0.1%
Other Number Analyzed 429 participants 426 participants 427 participants 1282 participants
5
   1.2%
4
   0.9%
6
   1.4%
15
   1.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 429 participants 426 participants 427 participants 1282 participants
119
  27.7%
117
  27.5%
125
  29.3%
361
  28.2%
Not Hispanic or Latino Number Analyzed 429 participants 426 participants 427 participants 1282 participants
310
  72.3%
309
  72.5%
302
  70.7%
921
  71.8%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 428 participants 424 participants 425 participants 1277 participants
30.70  (7.421) 31.22  (7.858) 30.63  (7.253) 30.85  (7.513)
[1]
Measure Analysis Population Description: The number analyzed indicates number of participants analyzed for this baseline characteristics.
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
Hide Description 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.
Time Frame Up to 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Measure Type: Number
Unit of Measure: percentage of participants
23.9 25.1 17.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline 75 mg, Placebo
Comments The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments Significance level of 0.025
Method Chi-square test statistic
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eluxadoline 100 mg, Placebo
Comments The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Significance level of 0.025
Method Chi-square test statistic
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
Hide Description 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.
Time Frame Up to 26 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Measure Type: Number
Unit of Measure: percentage of participants
23.4 29.3 19.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline 75 mg, Placebo
Comments The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments Significance level of 0.025
Method Chi-square test statistic
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eluxadoline 100 mg, Placebo
Comments The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significance level of 0.025
Method Chi-square test statistic
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 42.4 43.2 39.6
Responders during Weeks 1-26 45.2 46.5 43.3
Responders during Weeks 1-4 40.5 44.4 37.5
Responders during Weeks 5-8 44.5 47.2 45.4
Responders during Weeks 9-12 44.5 45.8 43.8
Responders during Weeks 13-16 44.3 44.1 45.4
Responders during Weeks 17-20 44.7 43.2 41.5
Responders during Weeks 21-24 44.7 42.0 38.4
4.Secondary Outcome
Title Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 30.0 34.3 22.0
Responders during Weeks 1-26 28.1 34.0 24.1
Responders during Weeks 1-4 28.8 31.5 19.0
Responders during Weeks 5-8 31.1 35.2 24.1
Responders during Weeks 9-12 29.0 35.2 24.6
Responders during Weeks 13-16 27.6 32.9 24.4
Responders during Weeks 17-20 31.9 31.5 23.7
Responders during Weeks 21-24 30.2 30.3 24.4
5.Secondary Outcome
Title Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 35.1 34.7 28.8
Responders during Weeks 1-26 36.3 37.1 32.3
Responders during Weeks 1-4 32.6 31.9 26.9
Responders during Weeks 5-8 37.0 38.7 32.8
Responders during Weeks 9-12 35.6 36.6 34.0
Responders during Weeks 13-16 35.8 35.9 35.4
Responders during Weeks 17-20 37.5 36.4 33.3
Responders during Weeks 21-24 36.8 35.2 29.5
6.Secondary Outcome
Title Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Hide Description 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.
Time Frame Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Measure Type: Number
Unit of Measure: percentage of participants
Responders at Week 4 42.6 44.1 37.0
Responders at Week 8 43.8 49.8 41.7
Responders at Week 12 44.3 48.1 44.0
Responders at Week 18 44.5 45.1 43.3
Responders at Week 26 45.4 45.1 40.0
Responders at Week 36 41.0 43.2 39.6
Responders at Week 44 39.6 40.1 37.5
Responders at Week 52/EOT 49.4 54.9 47.8
7.Secondary Outcome
Title Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
Hide Description 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.
Time Frame 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 52.9 54.2 43.8
Responders during Weeks 1-26 45.7 49.5 40.0
8.Secondary Outcome
Title Change From Baseline in Daily Abdominal Discomfort Scores
Hide Description 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.
Time Frame Baseline, Weeks 4, 12 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Week 4 Number Analyzed 392 participants 381 participants 401 participants
-2.24  (2.204) -2.41  (2.326) -2.01  (2.156)
Change at Week 12 Number Analyzed 338 participants 335 participants 335 participants
-2.75  (2.534) -2.97  (2.526) -2.61  (2.444)
Change at Week 26 Number Analyzed 264 participants 262 participants 264 participants
-3.27  (2.578) -3.52  (2.543) -3.00  (2.579)
9.Secondary Outcome
Title Change From Baseline in Daily Abdominal Bloating Scores
Hide Description 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.
Time Frame Baseline, Weeks 4, 12 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Week 4 Number Analyzed 330 participants 318 participants 329 participants
-1.84  (2.303) -2.03  (2.333) -1.72  (2.303)
Change at Week 12 Number Analyzed 277 participants 272 participants 274 participants
-2.42  (2.616) -2.49  (2.533) -2.16  (2.544)
Change at Week 26 Number Analyzed 209 participants 210 participants 210 participants
-2.76  (2.823) -2.94  (2.576) -2.47  (2.562)
10.Secondary Outcome
Title Number of Bowel Movements Per Day
Hide Description Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.
Time Frame Weeks 4, 12 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: bowel movements per day
Week 4 Number Analyzed 392 participants 381 participants 401 participants
3.20  (2.090) 3.20  (2.236) 3.72  (2.100)
Week 12 Number Analyzed 338 participants 335 participants 335 participants
3.12  (2.143) 3.09  (2.318) 3.44  (1.987)
Week 26 Number Analyzed 264 participants 262 participants 264 participants
2.83  (2.158) 2.79  (2.270) 3.12  (1.831)
11.Secondary Outcome
Title Number of Bowel Incontinence Episodes
Hide Description Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.
Time Frame Weeks 4, 12 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: incontinence episodes
Week 4 Number Analyzed 392 participants 381 participants 401 participants
0.74  (1.603) 0.72  (1.534) 0.93  (2.140)
Week 12 Number Analyzed 338 participants 335 participants 335 participants
0.63  (1.542) 0.71  (1.663) 0.94  (3.612)
Week 26 Number Analyzed 264 participants 262 participants 264 participants
0.46  (1.298) 0.58  (1.358) 0.69  (1.500)
12.Secondary Outcome
Title Number of Bowel Incontinence Free Days
Hide Description 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.
Time Frame Weeks 4, 12 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: days
Week 4 Number Analyzed 392 participants 381 participants 401 participants
4.83  (2.745) 4.95  (2.618) 4.63  (2.741)
Week 12 Number Analyzed 338 participants 335 participants 335 participants
4.96  (2.672) 4.79  (2.671) 4.64  (2.704)
Week 26 Number Analyzed 264 participants 262 participants 264 participants
4.39  (2.465) 4.35  (2.449) 4.00  (2.539)
13.Secondary Outcome
Title Number of Urgency Episodes Per Day
Hide Description Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.
Time Frame Weeks 4, 12 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: episodes per day
Week 4 Number Analyzed 392 participants 381 participants 401 participants
1.75  (1.840) 1.74  (1.879) 2.19  (2.082)
Week 12 Number Analyzed 338 participants 335 participants 335 participants
1.55  (1.777) 1.60  (1.995) 1.81  (1.883)
Week 26 Number Analyzed 264 participants 262 participants 264 participants
1.25  (1.773) 1.45  (2.113) 1.55  (1.853)
14.Secondary Outcome
Title IBS-QoL Total Scores
Hide Description 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.
Time Frame Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)
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Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: score on a scale
Responders at Week 4 Number Analyzed 384 participants 371 participants 392 participants
62.37  (23.747) 64.34  (24.049) 57.13  (24.318)
Responders at Week 8 Number Analyzed 354 participants 354 participants 360 participants
66.22  (23.919) 67.73  (23.421) 59.46  (24.323)
Responders at Week 12 Number Analyzed 339 participants 330 participants 342 participants
66.80  (24.131) 68.93  (23.938) 61.72  (25.545)
Responders at Week 18 Number Analyzed 315 participants 312 participants 315 participants
68.75  (23.902) 70.05  (23.662) 63.60  (24.618)
Responders at Week 26 Number Analyzed 288 participants 291 participants 290 participants
70.74  (23.312) 71.34  (23.106) 64.83  (24.380)
Responders at Week 36 Number Analyzed 277 participants 272 participants 278 participants
70.53  (23.043) 72.37  (23.246) 66.47  (24.034)
Responders at Week 44 Number Analyzed 267 participants 261 participants 271 participants
70.30  (24.408) 72.15  (24.398) 65.59  (25.045)
Responders at Week 52/EOT Number Analyzed 351 participants 353 participants 362 participants
68.85  (24.754) 71.02  (24.294) 63.93  (26.359)
15.Secondary Outcome
Title Change From Baseline in IBS-QoL Total Scores
Hide Description 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.
Time Frame Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT
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Hide Analysis Population Description
Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description:
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Overall Number of Participants Analyzed 427 426 427
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Week 4 Number Analyzed 382 participants 371 participants 392 participants
16.49  (20.693) 17.86  (20.191) 13.25  (18.475)
Change at Week 8 Number Analyzed 353 participants 354 participants 360 participants
19.88  (21.855) 21.08  (21.347) 15.76  (19.398)
Change at Week 12 Number Analyzed 337 participants 330 participants 342 participants
20.26  (23.412) 22.76  (22.592) 17.76  (21.523)
Change at Week 18 Number Analyzed 313 participants 312 participants 315 participants
23.09  (23.846) 24.18  (23.025) 19.80  (22.368)
Change at Week 26 Number Analyzed 288 participants 291 participants 290 participants
25.28  (23.679) 25.80  (23.998) 20.62  (22.306)
Change at Week 36 Number Analyzed 277 participants 272 participants 278 participants
25.37  (24.603) 27.18  (24.201) 22.64  (23.414)
Change at Week 44 Number Analyzed 267 participants 261 participants 271 participants
25.13  (24.948) 26.64  (25.017) 21.77  (23.977)
Change at Week 52/EOT Number Analyzed 349 participants 353 participants 362 participants
23.30  (23.959) 25.86  (23.854) 20.66  (23.956)
Time Frame Up to 54 weeks
Adverse Event Reporting Description The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
 
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
All-Cause Mortality
Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/428 (0.00%)   0/479 (0.00%)   0/427 (0.00%) 
Hide Serious Adverse Events
Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/428 (5.84%)   27/479 (5.64%)   16/427 (3.75%) 
Cardiac disorders       
Acute myocardial infarction  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Angina pectoris  1  1/428 (0.23%)  2/479 (0.42%)  0/427 (0.00%) 
Angina unstable  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Coronary artery disease  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Myocardial infarction  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Stress cardiomyopathy  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Eye disorders       
Papilloedema  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Gastrointestinal disorders       
Abdominal pain  1  1/428 (0.23%)  3/479 (0.63%)  0/427 (0.00%) 
Abdominal pain upper  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Colitis  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Diverticulum intestinal hemorrhagic  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Hemorrhoids  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Hiatus hernia  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Irritable bowel syndrome  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Pancreatitis  1  1/428 (0.23%)  1/479 (0.21%)  0/427 (0.00%) 
Pancreatitis acute  1  1/428 (0.23%)  2/479 (0.42%)  0/427 (0.00%) 
Small intestinal obstruction  1  0/428 (0.00%)  1/479 (0.21%)  1/427 (0.23%) 
General disorders       
Chest pain  1  1/428 (0.23%)  0/479 (0.00%)  1/427 (0.23%) 
Hepatobiliary disorders       
Cholecystitis chronic  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Infections and infestations       
Appendicitis  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Bronchitis  1  1/428 (0.23%)  1/479 (0.21%)  0/427 (0.00%) 
Cellulitis  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Diverticulitis  1  2/428 (0.47%)  1/479 (0.21%)  0/427 (0.00%) 
Escherichia infection  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Gastroenteritis  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Influenza  1  2/428 (0.47%)  0/479 (0.00%)  0/427 (0.00%) 
Necrotising fasciitis  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Pneumonia  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Rectal abscess  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Joint dislocation  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Procedural complication  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Radius fracture  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Road traffic accident  1  1/428 (0.23%)  2/479 (0.42%)  0/427 (0.00%) 
Skull fracture  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Spinal compression fracture  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Subdural hematoma  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Aspartate aminotransferase increased  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Hepatic enzyme increased  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/428 (0.00%)  1/479 (0.21%)  1/427 (0.23%) 
Diabetes mellitus  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Obesity  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Back pain  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Intervertebral disc protrusion  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Musculoskeletal pain  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Osteoarthritis  1  2/428 (0.47%)  0/479 (0.00%)  1/427 (0.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thyroid neoplasm  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Liposarcoma  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Nervous system disorders       
Hemiparesis  1  0/428 (0.00%)  0/479 (0.00%)  1/427 (0.23%) 
Intracranial pressure increased  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Presyncope  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Primary progressive multiple sclerosis  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Syncope  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Syncope vasovagal  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneousa  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Psychiatric disorders       
Anxiety  1  0/428 (0.00%)  2/479 (0.42%)  1/427 (0.23%) 
Conversion disorder  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Depression  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Renal and urinary disorders       
Hydronephrosis  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Asthma  1  0/428 (0.00%)  1/479 (0.21%)  1/427 (0.23%) 
Respiratory failure  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Vascular disorders       
Arteriosclerosis  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Deep vein thrombosis  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Hematoma  1  0/428 (0.00%)  1/479 (0.21%)  0/427 (0.00%) 
Hypertension  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
Hypertensive crisis  1  1/428 (0.23%)  0/479 (0.00%)  0/427 (0.00%) 
1
Term from vocabulary, MedDRA 11.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   84/428 (19.63%)   89/479 (18.58%)   47/427 (11.01%) 
Gastrointestinal disorders       
Constipation  1  27/428 (6.31%)  44/479 (9.19%)  12/427 (2.81%) 
Nausea  1  34/428 (7.94%)  31/479 (6.47%)  19/427 (4.45%) 
Vomiting  1  22/428 (5.14%)  19/479 (3.97%)  7/427 (1.64%) 
Infections and infestations       
Upper respiratory tract infection  1  14/428 (3.27%)  25/479 (5.22%)  15/427 (3.51%) 
1
Term from vocabulary, MedDRA 11.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor will work with the Investigators to determine how any manuscript or publication in a scientific journal is written and edited, the number and order of authors, the publication to which it will be submitted, and other related issues. The sponsor has final approval authority over all such issues. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01553591    
Other Study ID Numbers: 27018966IBS3001
2012-001600-38 ( EudraCT Number )
First Submitted: March 8, 2012
First Posted: March 14, 2012
Results First Submitted: June 11, 2018
Results First Posted: September 4, 2018
Last Update Posted: September 4, 2018