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

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: NCT01130272
Recruitment Status : Completed
First Posted : May 25, 2010
Results First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome
Interventions Drug: Eluxadoline
Drug: Placebo
Enrollment 807
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 Details 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
Hide 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 [1] 105 171 166 167 162
Safety Analysis Set: Highest Dose Level [2] 105 [3] 170 [4] 165 [5] 172 [6] 159 [7]
Completed 48 131 121 103 117
Not Completed 59 42 48 68 52
Reason Not Completed
Adverse Event             2             5             6             22             7
IVRS-confirmed constipation             0             1             1             2             0
Rescue medications due to diarrhea             3             5             8             8             6
Lack of efficacy- uncontrolled diarrhea             1             1             0             0             2
Lack of efficacy-uncontrolled IBS-d pain             0             0             0             1             0
Protocol Violation             0             0             3             5             5
Lost to Follow-up             4             3             4             7             6
Withdrawal by Subject             4             11             10             9             8
Physician Decision             1             1             0             1             2
Sponsor decision             6             15             16             13             16
Study arm discontinued             38             0             0             0             0
[1]
All participants who received study drug as per randomized dose assignment.
[2]
Reflects the reassignment of patients randomized more than once to the highest dose level arm.
[3]
105 total represents 1 patient in from Placebo arm; 1 patient out to 200 mg arm.
[4]
170 total represents 2 patients in from Placebo arm; 3 patients out to 200 mg arm.
[5]
165 total represents 1 patient out to 200 mg arm.
[6]
172 total represents 1 patient in from 5 mg; 3 patients in from 25 mg;1 patient in from 100 mg arms.
[7]
159 total represents 2 patients out to 25 mg arm; 1 patient out to 5 mg arm.
Arm/Group Title Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg Placebo Total
Hide 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 Number of Baseline Participants 107 173 169 171 169 789
Hide Baseline Analysis Population Description
All randomized patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
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  
Measure Type: Number
Unit of measure:  Participants
18 to 25 years Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
13 11 11 10 11 56
26 to 35 years Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
14 33 31 32 35 145
36 to 45 years Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
21 33 45 37 33 169
46 to 55 years Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
29 54 58 60 52 253
56 to 65 years Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
30 42 24 32 38 166
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
Female
76
  71.0%
120
  69.4%
117
  69.2%
119
  69.6%
118
  69.8%
550
  69.7%
Male
31
  29.0%
53
  30.6%
52
  30.8%
52
  30.4%
51
  30.2%
239
  30.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
90 144 145 147 150 676
Black or African American Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
12 21 18 18 17 86
Asian Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
3 4 3 4 2 16
American Indian or Alaska Native Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
1 2 0 0 0 3
Native Hawaiian or Other Pacific Islander Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
0 0 0 0 0 0
Other Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
1 2 3 2 0 8
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
13 31 32 22 24 122
Not Hispanic or Latino Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
94 142 137 149 145 667
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 107 participants 173 participants 169 participants 171 participants 169 participants 789 participants
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   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 107 participants 173 participants 167 participants 166 participants 162 participants 775 participants
89.10  (23.027) 83.95  (23.657) 86.04  (23.796) 86.53  (21.584) 86.28  (21.246) 86.15  (22.671)
[1]
Measure Analysis Population Description: Number analyzed is the number of participants with available weight data for analysis.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 107 participants 173 participants 167 participants 166 participants 162 participants 775 participants
31.88  (7.739) 30.41  (8.398) 30.16  (7.059) 30.71  (7.290) 30.81  (7.443) 30.71  (7.595)
[1]
Measure Analysis Population Description: Number analyzed is the number of participants with available BMI data for analysis.
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 105 167 163 160 159
Measure Type: Number
Unit of Measure: percentage of participants
12.4 12.0 11.0 13.8 5.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.457
Confidence Interval (2-Sided) 95%
0.994 to 6.077
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eluxadoline 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.383
Confidence Interval (2-Sided) 95%
1.036 to 5.478
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eluxadoline 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.079
Confidence Interval (2-Sided) 95%
0.893 to 4.842
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Eluxadoline 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.797
Confidence Interval (2-Sided) 95%
1.227 to 6.376
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 105 167 163 160 159
Measure Type: Number
Unit of Measure: percentage of participants
8.6 13.2 20.2 15.0 11.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.719
Confidence Interval (2-Sided) 95%
0.306 to 1.689
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eluxadoline 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.583
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.208
Confidence Interval (2-Sided) 95%
0.615 to 2.373
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eluxadoline 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.014
Confidence Interval (2-Sided) 95%
1.069 to 3.795
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Eluxadoline 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.326
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.395
Confidence Interval (2-Sided) 95%
0.717 to 2.716
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Weekly Pain Scores
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 105 167 163 160 159
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 105 participants 167 participants 163 participants 160 participants 159 participants
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 Number Analyzed 97 participants 155 participants 143 participants 140 participants 146 participants
-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 Number Analyzed 82 participants 141 participants 132 participants 120 participants 135 participants
-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 Number Analyzed 58 participants 131 participants 124 participants 107 participants 118 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 105 167 163 160 159
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 105 participants 167 participants 163 participants 160 participants 159 participants
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 Number Analyzed 97 participants 154 participants 143 participants 140 participants 146 participants
-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 Number Analyzed 82 participants 141 participants 132 participants 120 participants 135 participants
-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 Number Analyzed 58 participants 131 participants 123 participants 107 participants 118 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 105 167 163 160 159
Mean (Standard Deviation)
Unit of Measure: bowel movements per day
Baseline Number Analyzed 105 participants 167 participants 163 participants 160 participants 159 participants
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 Number Analyzed 97 participants 155 participants 143 participants 140 participants 146 participants
-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 Number Analyzed 82 participants 141 participants 132 participants 120 participants 135 participants
-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 Number Analyzed 58 participants 131 participants 124 participants 107 participants 118 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 105 167 163 160 159
Measure Type: Number
Unit of Measure: percentage of participants
Weeks 1-12 Number Analyzed 105 participants 167 participants 163 participants 160 participants 159 participants
16.5 20.2 29.7 30.6 19.0
Weeks 1-4 Number Analyzed 105 participants 167 participants 163 participants 160 participants 159 participants
18.0 21.0 24.9 32.7 20.0
Weeks 5-8 Number Analyzed 90 participants 146 participants 137 participants 125 participants 139 participants
29.3 34.4 43.0 39.3 30.3
Weeks 9-12 Number Analyzed 72 participants 137 participants 129 participants 109 participants 126 participants
29.7 34.4 49.1 50.7 31.0
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/159 (0.63%)   1/105 (0.95%)   3/170 (1.76%)   1/165 (0.61%)   3/172 (1.74%) 
Gastrointestinal disorders           
Pancreatitis † 1  0/159 (0.00%)  0/105 (0.00%)  1/170 (0.59%)  0/165 (0.00%)  0/172 (0.00%) 
Alcoholic pancreatitis † 1  0/159 (0.00%)  0/105 (0.00%)  0/170 (0.00%)  0/165 (0.00%)  1/172 (0.58%) 
Pancreatitis acute † 1  0/159 (0.00%)  0/105 (0.00%)  0/170 (0.00%)  1/165 (0.61%)  1/172 (0.58%) 
Appendicitis perforated † 1  0/159 (0.00%)  0/105 (0.00%)  0/170 (0.00%)  0/165 (0.00%)  1/172 (0.58%) 
General disorders           
Noncardiac chest pain † 1  0/159 (0.00%)  1/105 (0.95%)  0/170 (0.00%)  0/165 (0.00%)  0/172 (0.00%) 
Infections and infestations           
Pneumonia † 1  0/159 (0.00%)  0/105 (0.00%)  1/170 (0.59%)  0/165 (0.00%)  0/172 (0.00%) 
Psychiatric disorders           
Anxiety † 1  1/159 (0.63%)  0/105 (0.00%)  0/170 (0.00%)  0/165 (0.00%)  0/172 (0.00%) 
Depression † 1  1/159 (0.63%)  0/105 (0.00%)  0/170 (0.00%)  0/165 (0.00%)  0/172 (0.00%) 
Major depression † 1  0/159 (0.00%)  0/105 (0.00%)  1/170 (0.59%)  0/165 (0.00%)  0/172 (0.00%) 
Affective disorder † 1  0/159 (0.00%)  0/105 (0.00%)  1/170 (0.59%)  0/165 (0.00%)  0/172 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Eluxadoline 5 mg Eluxadoline 25 mg Eluxadoline 100 mg Eluxadoline 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/159 (15.72%)   20/105 (19.05%)   34/170 (20.00%)   27/165 (16.36%)   43/172 (25.00%) 
Gastrointestinal disorders           
Nausea † 1  7/159 (4.40%)  6/105 (5.71%)  11/170 (6.47%)  9/165 (5.45%)  18/172 (10.47%) 
Abdominal pain † 1  3/159 (1.89%)  3/105 (2.86%)  6/170 (3.53%)  4/165 (2.42%)  13/172 (7.56%) 
Vomiting † 1  1/159 (0.63%)  1/105 (0.95%)  7/170 (4.12%)  7/165 (4.24%)  12/172 (6.98%) 
Constipation † 1  4/159 (2.52%)  2/105 (1.90%)  5/170 (2.94%)  10/165 (6.06%)  6/172 (3.49%) 
Infections and infestations           
Sinusitis † 1  9/159 (5.66%)  5/105 (4.76%)  4/170 (2.35%)  3/165 (1.82%)  1/172 (0.58%) 
Nervous system disorders           
Dizziness † 1  4/159 (2.52%)  4/105 (3.81%)  4/170 (2.35%)  5/165 (3.03%)  11/172 (6.40%) 
Headache † 1  6/159 (3.77%)  3/105 (2.86%)  12/170 (7.06%)  5/165 (3.03%)  7/172 (4.07%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
[Not Specified]
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.
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
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01130272    
Other Study ID Numbers: 27018966IBS2001
First Submitted: May 24, 2010
First Posted: May 25, 2010
Results First Submitted: August 22, 2019
Results First Posted: October 22, 2019
Last Update Posted: October 22, 2019