Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (NCT NCT01553747)
NCT ID: NCT01553747
Last Updated: 2018-07-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1146 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2018-07-30
Participant Flow
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.
Participant milestones
| Measure |
Eluxadoline 75 mg
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
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.
|
Placebo
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 Study
STARTED
|
381
|
383
|
382
|
|
Overall Study
Attended Week 12 Visit
|
296
|
301
|
312
|
|
Overall Study
Attended Week 26 Visit
|
259
|
271
|
278
|
|
Overall Study
Participated in Blinded-Placebo Period
|
246
|
253
|
272
|
|
Overall Study
COMPLETED
|
250
|
264
|
273
|
|
Overall Study
NOT COMPLETED
|
131
|
119
|
109
|
Reasons for withdrawal
| Measure |
Eluxadoline 75 mg
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
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.
|
Placebo
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 Study
Protocol Violation
|
0
|
2
|
0
|
|
Overall Study
Voluntarily withdrew
|
70
|
66
|
74
|
|
Overall Study
Adverse event or SAE
|
32
|
28
|
19
|
|
Overall Study
Physician decision: other
|
10
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
11
|
5
|
6
|
|
Overall Study
Sponsor decision, specify
|
7
|
5
|
0
|
|
Overall Study
Physician decision: lack of efficacy
|
1
|
5
|
3
|
Baseline Characteristics
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
Baseline characteristics by cohort
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=383 Participants
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.
|
Placebo
n=382 Participants
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
n=1146 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 13.31 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 13.82 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 13.45 • n=4 Participants
|
|
Age, Customized
18-40 years
|
139 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
418 Participants
n=4 Participants
|
|
Age, Customized
41-64 years
|
206 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
602 Participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
261 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
768 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
378 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
|
28.9 percentage of participants
|
29.6 percentage of participants
|
16.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
|
30.4 percentage of participants
|
32.7 percentage of participants
|
20.2 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 1-12
|
48.0 percentage of participants
|
51.0 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 1-26
|
47.5 percentage of participants
|
50.0 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 1-4
|
46.7 percentage of participants
|
46.6 percentage of participants
|
41.9 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 5-8
|
53.0 percentage of participants
|
52.9 percentage of participants
|
49.2 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 13-16
|
47.2 percentage of participants
|
49.0 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 17-20
|
45.1 percentage of participants
|
47.4 percentage of participants
|
42.7 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 21-24
|
41.7 percentage of participants
|
46.9 percentage of participants
|
40.6 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 9-12
|
48.0 percentage of participants
|
50.3 percentage of participants
|
46.9 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 5-8
|
37.5 percentage of participants
|
38.2 percentage of participants
|
23.3 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 1-12
|
37.0 percentage of participants
|
35.6 percentage of participants
|
20.9 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 1-26
|
34.4 percentage of participants
|
39.8 percentage of participants
|
23.6 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 1-4
|
34.6 percentage of participants
|
37.2 percentage of participants
|
18.1 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 9-12
|
37.5 percentage of participants
|
39.3 percentage of participants
|
26.4 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 13-16
|
36.2 percentage of participants
|
41.4 percentage of participants
|
24.9 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 17-20
|
33.9 percentage of participants
|
36.1 percentage of participants
|
24.9 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 21-24
|
32.5 percentage of participants
|
38.2 percentage of participants
|
22.8 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 1-12
|
43.6 percentage of participants
|
42.4 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 1-26
|
45.1 percentage of participants
|
43.2 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 1-4
|
40.2 percentage of participants
|
36.9 percentage of participants
|
25.7 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 5-8
|
45.1 percentage of participants
|
45.0 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 9-12
|
44.9 percentage of participants
|
43.5 percentage of participants
|
34.0 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 13-16
|
43.8 percentage of participants
|
42.9 percentage of participants
|
33.0 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 17-20
|
42.5 percentage of participants
|
40.8 percentage of participants
|
33.2 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 21-24
|
41.7 percentage of participants
|
41.6 percentage of participants
|
33.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 4
|
45.1 percentage of participants
|
45.5 percentage of participants
|
40.1 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 8
|
48.8 percentage of participants
|
50.0 percentage of participants
|
43.7 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 12
|
48.3 percentage of participants
|
49.5 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 18
|
45.1 percentage of participants
|
45.0 percentage of participants
|
41.9 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 26
|
45.4 percentage of participants
|
44.8 percentage of participants
|
41.4 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 30 /EOT
|
54.3 percentage of participants
|
53.9 percentage of participants
|
52.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
Responders during Weeks 1-12
|
60.1 percentage of participants
|
58.4 percentage of participants
|
49.2 percentage of participants
|
|
Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
Responders during Weeks 1-26
|
52.8 percentage of participants
|
53.7 percentage of participants
|
43.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12 and 26Population: 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.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Daily Abdominal Discomfort Scores
Change at Week 4
|
-2.44 score on a scale
Standard Deviation 2.219
|
-2.19 score on a scale
Standard Deviation 2.120
|
-2.06 score on a scale
Standard Deviation 2.063
|
|
Change From Baseline in Daily Abdominal Discomfort Scores
Change at Week 12
|
-2.88 score on a scale
Standard Deviation 2.417
|
-2.90 score on a scale
Standard Deviation 2.175
|
-2.56 score on a scale
Standard Deviation 2.461
|
|
Change From Baseline in Daily Abdominal Discomfort Scores
Change at Week 26
|
-3.19 score on a scale
Standard Deviation 2.454
|
-3.16 score on a scale
Standard Deviation 2.362
|
-2.76 score on a scale
Standard Deviation 2.582
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12 and 26Population: 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.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Daily Abdominal Bloating Scores
Change at Week 4
|
-1.89 score on a scale
Standard Deviation 2.170
|
-1.80 score on a scale
Standard Deviation 2.204
|
-1.73 score on a scale
Standard Deviation 2.081
|
|
Change From Baseline in Daily Abdominal Bloating Scores
Change at Week 12
|
-2.24 score on a scale
Standard Deviation 2.445
|
-2.41 score on a scale
Standard Deviation 2.396
|
-2.08 score on a scale
Standard Deviation 2.492
|
|
Change From Baseline in Daily Abdominal Bloating Scores
Change at Week 26
|
-2.38 score on a scale
Standard Deviation 2.619
|
-2.68 score on a scale
Standard Deviation 2.673
|
-2.17 score on a scale
Standard Deviation 2.682
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: 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.
Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Number of Bowel Movements Per Day
Week 4
|
3.03 bowel movements per day
Standard Deviation 2.021
|
3.05 bowel movements per day
Standard Deviation 1.962
|
3.38 bowel movements per day
Standard Deviation 1.856
|
|
Number of Bowel Movements Per Day
Week 12
|
2.89 bowel movements per day
Standard Deviation 2.057
|
2.80 bowel movements per day
Standard Deviation 1.685
|
3.15 bowel movements per day
Standard Deviation 1.991
|
|
Number of Bowel Movements Per Day
Week 26
|
2.57 bowel movements per day
Standard Deviation 1.637
|
2.66 bowel movements per day
Standard Deviation 1.625
|
2.96 bowel movements per day
Standard Deviation 1.931
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: 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.
Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Number of Bowel Incontinence Episodes
Week 4
|
0.47 incontinence episodes
Standard Deviation 1.304
|
0.41 incontinence episodes
Standard Deviation 1.230
|
0.50 incontinence episodes
Standard Deviation 1.195
|
|
Number of Bowel Incontinence Episodes
Week 12
|
0.40 incontinence episodes
Standard Deviation 1.083
|
0.28 incontinence episodes
Standard Deviation 0.875
|
0.46 incontinence episodes
Standard Deviation 1.269
|
|
Number of Bowel Incontinence Episodes
Week 26
|
0.30 incontinence episodes
Standard Deviation 0.982
|
0.27 incontinence episodes
Standard Deviation 0.844
|
0.50 incontinence episodes
Standard Deviation 1.503
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: 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.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Number of Bowel Incontinence Free Days
Week 4
|
5.53 days
Standard Deviation 2.282
|
5.46 days
Standard Deviation 2.264
|
5.31 days
Standard Deviation 2.444
|
|
Number of Bowel Incontinence Free Days
Week 12
|
5.38 days
Standard Deviation 2.320
|
5.56 days
Standard Deviation 2.164
|
5.28 days
Standard Deviation 2.364
|
|
Number of Bowel Incontinence Free Days
Week 26
|
5.53 days
Standard Deviation 2.129
|
5.59 days
Standard Deviation 2.216
|
5.29 days
Standard Deviation 2.322
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: 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.
Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Number of Urgency Episodes Per Day
Week 4
|
1.62 episodes per day
Standard Deviation 1.948
|
1.58 episodes per day
Standard Deviation 1.732
|
2.00 episodes per day
Standard Deviation 1.779
|
|
Number of Urgency Episodes Per Day
Week 12
|
1.37 episodes per day
Standard Deviation 1.884
|
1.32 episodes per day
Standard Deviation 1.675
|
1.73 episodes per day
Standard Deviation 1.785
|
|
Number of Urgency Episodes Per Day
Week 26
|
1.13 episodes per day
Standard Deviation 1.580
|
1.12 episodes per day
Standard Deviation 1.576
|
1.54 episodes per day
Standard Deviation 1.826
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOTPopulation: 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.
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.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=381 Participants
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
n=382 Participants
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.
|
Placebo
n=382 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 4
|
17.51 score on a scale
Standard Deviation 19.755
|
17.26 score on a scale
Standard Deviation 18.980
|
14.07 score on a scale
Standard Deviation 18.787
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 8
|
21.60 score on a scale
Standard Deviation 20.762
|
21.10 score on a scale
Standard Deviation 21.925
|
16.62 score on a scale
Standard Deviation 20.856
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 12
|
22.69 score on a scale
Standard Deviation 21.723
|
22.62 score on a scale
Standard Deviation 24.017
|
19.50 score on a scale
Standard Deviation 21.636
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 30/EOT
|
22.79 score on a scale
Standard Deviation 22.329
|
20.92 score on a scale
Standard Deviation 23.724
|
21.63 score on a scale
Standard Deviation 23.376
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 18
|
24.17 score on a scale
Standard Deviation 22.761
|
23.52 score on a scale
Standard Deviation 24.029
|
20.64 score on a scale
Standard Deviation 23.268
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 26
|
24.91 score on a scale
Standard Deviation 22.638
|
24.19 score on a scale
Standard Deviation 24.599
|
21.50 score on a scale
Standard Deviation 23.709
|
Adverse Events
Eluxadoline 75 mg (Treatment Period)
Serious events: 9 serious events
Other events: 97 other events
Deaths: 0 deaths
Eluxadoline 100 mg (Treatment Period)
Serious events: 14 serious events
Other events: 97 other events
Deaths: 0 deaths
Placebo (Treatment Period)
Serious events: 8 serious events
Other events: 69 other events
Deaths: 0 deaths
Eluxadoline 75 mg (Blinded-Placebo Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eluxadoline 100 mg (Blinded-Placebo Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Blinded-Placebo Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eluxadoline 75 mg (Treatment Period)
n=379 participants at risk
Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
|
Eluxadoline 100 mg (Treatment Period)
n=380 participants at risk
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
|
Placebo (Treatment Period)
n=381 participants at risk
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
|
Eluxadoline 75 mg (Blinded-Placebo Period)
n=246 participants at risk
Participants who received eluxadoline 75 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.
|
Eluxadoline 100 mg (Blinded-Placebo Period)
n=253 participants at risk
Participants who received eluxadoline 100 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.
|
Placebo (Blinded-Placebo Period)
n=272 participants at risk
Participants who received placebo matching tablets in treatment period were administered with placebo orally, twice daily for next 4 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Colitis ischemic
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Appendicitis
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Enterocolitis infections
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
General disorders
Chest pain
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
General disorders
Non-cardiac pain
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Cardiac disorders
Angina pectoris
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Investigations
ECG T wave abnormal
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Investigations
Hepatic enzyme increased
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.26%
1/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/380 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/379 • From first dose of study drug up to 30 weeks
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.
|
0.26%
1/380 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
Other adverse events
| Measure |
Eluxadoline 75 mg (Treatment Period)
n=379 participants at risk
Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
|
Eluxadoline 100 mg (Treatment Period)
n=380 participants at risk
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
|
Placebo (Treatment Period)
n=381 participants at risk
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
|
Eluxadoline 75 mg (Blinded-Placebo Period)
n=246 participants at risk
Participants who received eluxadoline 75 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.
|
Eluxadoline 100 mg (Blinded-Placebo Period)
n=253 participants at risk
Participants who received eluxadoline 100 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.
|
Placebo (Blinded-Placebo Period)
n=272 participants at risk
Participants who received placebo matching tablets in treatment period were administered with placebo orally, twice daily for next 4 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.7%
33/379 • From first dose of study drug up to 30 weeks
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.
|
7.9%
30/380 • From first dose of study drug up to 30 weeks
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.
|
2.1%
8/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Gastrointestinal disorders
Nausea
|
8.2%
31/379 • From first dose of study drug up to 30 weeks
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.
|
8.7%
33/380 • From first dose of study drug up to 30 weeks
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.
|
5.8%
22/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
19/379 • From first dose of study drug up to 30 weeks
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.
|
3.4%
13/380 • From first dose of study drug up to 30 weeks
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.
|
3.9%
15/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
13/379 • From first dose of study drug up to 30 weeks
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.
|
5.8%
22/380 • From first dose of study drug up to 30 weeks
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.
|
4.5%
17/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
|
Nervous system disorders
Headache
|
3.7%
14/379 • From first dose of study drug up to 30 weeks
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.
|
6.1%
23/380 • From first dose of study drug up to 30 weeks
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.
|
5.8%
22/381 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/246 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/253 • From first dose of study drug up to 30 weeks
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.
|
0.00%
0/272 • From first dose of study drug up to 30 weeks
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER