We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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: NCT01553747
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : July 30, 2018
Last Update Posted : July 30, 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 1146
Recruitment Details  
Pre-assignment Details 3356 participants were prescreened and entered into interactive voice response system for participation in the study. 1146 participants were randomized. One participant was unintentionally randomized twice and was assigned 2 different participant identification numbers due to participant trying to participate at more than 1 study center at once.
Arm/Group Title Eluxadoline 75 mg Eluxadoline 100 mg Placebo
Hide Arm/Group Description Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Period Title: Overall Study
Started 381 383 382
Attended Week 12 Visit 296 301 312
Attended Week 26 Visit 259 271 278
Participated in Blinded-Placebo Period 246 253 272
Completed 250 264 273
Not Completed 131 119 109
Reason Not Completed
Protocol Violation             0             2             0
Voluntarily withdrew             70             66             74
Adverse event or SAE             32             28             19
Physician decision: other             10             8             7
Lost to Follow-up             11             5             6
Sponsor decision, specify             7             5             0
Physician decision: lack of efficacy             1             5             3
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period. Total of all reporting groups
Overall Number of Baseline Participants 381 383 382 1146
Hide Baseline Analysis Population Description
Enrolled set included all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 381 participants 383 participants 382 participants 1146 participants
45.0  (13.17) 45.7  (13.31) 47.1  (13.82) 45.9  (13.45)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 383 participants 382 participants 1146 participants
18-40 years
139
  36.5%
146
  38.1%
133
  34.8%
418
  36.5%
41-64 years
206
  54.1%
198
  51.7%
198
  51.8%
602
  52.5%
≥65 years
36
   9.4%
39
  10.2%
51
  13.4%
126
  11.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 383 participants 382 participants 1146 participants
Female
261
  68.5%
257
  67.1%
250
  65.4%
768
  67.0%
Male
120
  31.5%
126
  32.9%
132
  34.6%
378
  33.0%
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 participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Measure Type: Number
Unit of Measure: percentage of participants
28.9 29.6 16.2
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 <0.001
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]
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 participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Measure Type: Number
Unit of Measure: percentage of participants
30.4 32.7 20.2
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 0.001
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 48.0 51.0 45.3
Responders during Weeks 1-26 47.5 50.0 44.8
Responders during Weeks 1-4 46.7 46.6 41.9
Responders during Weeks 5-8 53.0 52.9 49.2
Responders during Weeks 9-12 48.0 50.3 46.9
Responders during Weeks 13-16 47.2 49.0 43.5
Responders during Weeks 17-20 45.1 47.4 42.7
Responders during Weeks 21-24 41.7 46.9 40.6
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 37.0 35.6 20.9
Responders during Weeks 1-26 34.4 39.8 23.6
Responders during Weeks 1-4 34.6 37.2 18.1
Responders during Weeks 5-8 37.5 38.2 23.3
Responders during Weeks 9-12 37.5 39.3 26.4
Responders during Weeks 13-16 36.2 41.4 24.9
Responders during Weeks 17-20 33.9 36.1 24.9
Responders during Weeks 21-24 32.5 38.2 22.8
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 43.6 42.4 29.6
Responders during Weeks 1-26 45.1 43.2 34.3
Responders during Weeks 1-4 40.2 36.9 25.7
Responders during Weeks 5-8 45.1 45.0 35.1
Responders during Weeks 9-12 44.9 43.5 34.0
Responders during Weeks 13-16 43.8 42.9 33.0
Responders during Weeks 17-20 42.5 40.8 33.2
Responders during Weeks 21-24 41.7 41.6 33.8
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 and 30 (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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Measure Type: Number
Unit of Measure: percentage of participants
Responders at Week 4 45.1 45.5 40.1
Responders at Week 8 48.8 50.0 43.7
Responders at Week 12 48.3 49.5 45.0
Responders at Week 18 45.1 45.0 41.9
Responders at Week 26 45.4 44.8 41.4
Responders at Week 30 /EOT 54.3 53.9 52.6
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Measure Type: Number
Unit of Measure: percentage of participants
Responders during Weeks 1-12 60.1 58.4 49.2
Responders during Weeks 1-26 52.8 53.7 43.7
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
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Week 4 Number Analyzed 348 participants 351 participants 364 participants
-2.44  (2.219) -2.19  (2.120) -2.06  (2.063)
Change at Week 12 Number Analyzed 298 participants 303 participants 316 participants
-2.88  (2.417) -2.90  (2.175) -2.56  (2.461)
Change at Week 26 Number Analyzed 255 participants 267 participants 267 participants
-3.19  (2.454) -3.16  (2.362) -2.76  (2.582)
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
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Week 4 Number Analyzed 292 participants 305 participants 302 participants
-1.89  (2.170) -1.80  (2.204) -1.73  (2.081)
Change at Week 12 Number Analyzed 247 participants 262 participants 259 participants
-2.24  (2.445) -2.41  (2.396) -2.08  (2.492)
Change at Week 26 Number Analyzed 210 participants 229 participants 214 participants
-2.38  (2.619) -2.68  (2.673) -2.17  (2.682)
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
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Mean (Standard Deviation)
Unit of Measure: bowel movements per day
Week 4 Number Analyzed 348 participants 351 participants 364 participants
3.03  (2.021) 3.05  (1.962) 3.38  (1.856)
Week 12 Number Analyzed 298 participants 303 participants 316 participants
2.89  (2.057) 2.80  (1.685) 3.15  (1.991)
Week 26 Number Analyzed 255 participants 267 participants 267 participants
2.57  (1.637) 2.66  (1.625) 2.96  (1.931)
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
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Mean (Standard Deviation)
Unit of Measure: incontinence episodes
Week 4 Number Analyzed 348 participants 351 participants 364 participants
0.47  (1.304) 0.41  (1.230) 0.50  (1.195)
Week 12 Number Analyzed 298 participants 303 participants 316 participants
0.40  (1.083) 0.28  (0.875) 0.46  (1.269)
Week 26 Number Analyzed 255 participants 267 participants 267 participants
0.30  (0.982) 0.27  (0.844) 0.50  (1.503)
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
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Mean (Standard Deviation)
Unit of Measure: days
Week 4 Number Analyzed 348 participants 351 participants 364 participants
5.53  (2.282) 5.46  (2.264) 5.31  (2.444)
Week 12 Number Analyzed 298 participants 303 participants 316 participants
5.38  (2.320) 5.56  (2.164) 5.28  (2.364)
Week 26 Number Analyzed 255 participants 267 participants 267 participants
5.53  (2.129) 5.59  (2.216) 5.29  (2.322)
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
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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Mean (Standard Deviation)
Unit of Measure: episodes per day
Week 4 Number Analyzed 348 participants 351 participants 364 participants
1.62  (1.948) 1.58  (1.732) 2.00  (1.779)
Week 12 Number Analyzed 298 participants 303 participants 316 participants
1.37  (1.884) 1.32  (1.675) 1.73  (1.785)
Week 26 Number Analyzed 255 participants 267 participants 267 participants
1.13  (1.580) 1.12  (1.576) 1.54  (1.826)
14.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 and 30/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. 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 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
Overall Number of Participants Analyzed 381 382 382
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Week 4 Number Analyzed 335 participants 342 participants 357 participants
17.51  (19.755) 17.26  (18.980) 14.07  (18.787)
Change at Week 8 Number Analyzed 318 participants 319 participants 333 participants
21.60  (20.762) 21.10  (21.925) 16.62  (20.856)
Change at Week 12 Number Analyzed 293 participants 300 participants 311 participants
22.69  (21.723) 22.62  (24.017) 19.50  (21.636)
Change at Week 18 Number Analyzed 275 participants 281 participants 293 participants
24.17  (22.761) 23.52  (24.029) 20.64  (23.268)
Change at Week 26 Number Analyzed 258 participants 271 participants 277 participants
24.91  (22.638) 24.19  (24.599) 21.50  (23.709)
Change at Week 30/EOT Number Analyzed 335 participants 344 participants 342 participants
22.79  (22.329) 20.92  (23.724) 21.63  (23.376)
Time Frame From first dose of study drug up to 30 weeks
Adverse Event Reporting Description Safety Set: all participants who received at least 1 dose of drug per actual treatment received. 1 participant in 100 mg arm received 75 mg, 2 participants in Placebo arm received eluxadoline 75 mg and 100 mg. AEs for each period were analyzed separately. In the Other AE section, a result of 0 in an arm means the ≥5% threshold was not met.
 
Arm/Group Title Eluxadoline 75 mg (Treatment Period) Eluxadoline 100 mg (Treatment Period) Placebo (Treatment Period) Eluxadoline 75 mg (Blinded-Placebo Period) Eluxadoline 100 mg (Blinded-Placebo Period) Placebo (Blinded-Placebo Period)
Hide Arm/Group Description Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period. Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period. Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period. Participants who received eluxadoline 75 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks. Participants who received eluxadoline 100 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks. Participants who received placebo matching tablets in treatment period were administered with placebo orally, twice daily for next 4 weeks.
All-Cause Mortality
Eluxadoline 75 mg (Treatment Period) Eluxadoline 100 mg (Treatment Period) Placebo (Treatment Period) Eluxadoline 75 mg (Blinded-Placebo Period) Eluxadoline 100 mg (Blinded-Placebo Period) Placebo (Blinded-Placebo Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/379 (0.00%)   0/380 (0.00%)   0/381 (0.00%)   0/246 (0.00%)   0/253 (0.00%)   0/272 (0.00%) 
Hide Serious Adverse Events
Eluxadoline 75 mg (Treatment Period) Eluxadoline 100 mg (Treatment Period) Placebo (Treatment Period) Eluxadoline 75 mg (Blinded-Placebo Period) Eluxadoline 100 mg (Blinded-Placebo Period) Placebo (Blinded-Placebo Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/379 (2.37%)   14/380 (3.68%)   8/381 (2.10%)   0/246 (0.00%)   0/253 (0.00%)   0/272 (0.00%) 
Cardiac disorders             
Acute coronary syndrome  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Angina pectoris  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Coronary artery disease  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Gastrointestinal disorders             
Abdominal discomfort  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Colitis ischemic  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Dyspepsia  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Gastric ulcer  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Hiatus hernia  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Pancreatitis acute  1  1/379 (0.26%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Umbilical hernia  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
General disorders             
Chest pain  1  1/379 (0.26%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Non-cardiac pain  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Hepatobiliary disorders             
Hepatitis  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Infections and infestations             
Appendicitis  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Bacterial pyelonephritis  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Enterocolitis infections  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Liver abscess  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Pyelonephritis  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Urinary tract infection  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Injury, poisoning and procedural complications             
Concussion  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Pseudomeningocele  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Investigations             
ECG T wave abnormal  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Hepatic enzyme increased  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Nervous system disorders             
Headache  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Myasthenia gravis  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Psychiatric disorders             
Suicide attempt  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Renal and urinary disorders             
Nephrolithiasis  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Reproductive system and breast disorders             
Dysfunctional uterine bleeding  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Ovarian cyst ruptured  1  1/379 (0.26%)  0/380 (0.00%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Uterine prolapse  1  0/379 (0.00%)  0/380 (0.00%)  1/381 (0.26%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis contact  1  0/379 (0.00%)  1/380 (0.26%)  0/381 (0.00%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
1
Term from vocabulary, MedDRA version 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 (Treatment Period) Eluxadoline 100 mg (Treatment Period) Placebo (Treatment Period) Eluxadoline 75 mg (Blinded-Placebo Period) Eluxadoline 100 mg (Blinded-Placebo Period) Placebo (Blinded-Placebo Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   97/379 (25.59%)   97/380 (25.53%)   69/381 (18.11%)   0/246 (0.00%)   0/253 (0.00%)   0/272 (0.00%) 
Gastrointestinal disorders             
Constipation  1  33/379 (8.71%)  30/380 (7.89%)  8/381 (2.10%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Nausea  1  31/379 (8.18%)  33/380 (8.68%)  22/381 (5.77%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Infections and infestations             
Nasopharyngitis  1  19/379 (5.01%)  13/380 (3.42%)  15/381 (3.94%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Upper respiratory tract infection  1  13/379 (3.43%)  22/380 (5.79%)  17/381 (4.46%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
Nervous system disorders             
Headache  1  14/379 (3.69%)  23/380 (6.05%)  22/381 (5.77%)  0/246 (0.00%)  0/253 (0.00%)  0/272 (0.00%) 
1
Term from vocabulary, MedDRA version 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: NCT01553747    
Other Study ID Numbers: 27018966IBS3002
2012-001601-24 ( EudraCT Number )
First Submitted: March 8, 2012
First Posted: March 14, 2012
Results First Submitted: June 11, 2018
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018