Trial Outcomes & Findings for Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation (NCT NCT01833065)
NCT ID: NCT01833065
Last Updated: 2015-10-20
Results Overview
This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
314 participants
Primary outcome timeframe
During the first 12 weeks
Results posted on
2015-10-20
Participant Flow
Trial included 4-week Screening and 2-week Pretreatment Period before patient randomization to treatment sequences i.e. EBX 10/EBX 10, EBX 10/PLCBO, EBX 5/EBX 5, EBX 5/PLCBO and PLCBO/EBX 10. The total study duration was of 16 weeks: the efficacy assessments focused on the first 12 weeks, while safety assessments focused on whole 16 weeks
Participant milestones
| Measure |
EBX 10/EBX 10
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
EBX 10/PLCBO
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
EBX 5/EBX 5
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
EBX 5/PLCBO
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
PLCBO/EBX 10
Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
53
|
35
|
50
|
110
|
|
Overall Study
Intention-to-treat Analysis Set
|
50
|
53
|
50
|
50
|
111
|
|
Overall Study
COMPLETED
|
41
|
40
|
23
|
41
|
74
|
|
Overall Study
NOT COMPLETED
|
24
|
13
|
12
|
9
|
36
|
Reasons for withdrawal
| Measure |
EBX 10/EBX 10
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
EBX 10/PLCBO
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
EBX 5/EBX 5
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
EBX 5/PLCBO
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
PLCBO/EBX 10
Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
0
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
4
|
3
|
11
|
|
Overall Study
Subject's substantial non-compliance
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Trial terminated by sponsor
|
8
|
8
|
7
|
3
|
13
|
|
Overall Study
Others
|
2
|
1
|
1
|
1
|
4
|
Baseline Characteristics
Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation
Baseline characteristics by cohort
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form.
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.6 Years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
49.5 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
48.0 Years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
49.0 Years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
266 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
285 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
54 participants
n=7 Participants
|
55 participants
n=5 Participants
|
158 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Weekly number of CSBM
|
0.33 CSBM per week
STANDARD_DEVIATION 0.62 • n=5 Participants
|
0.32 CSBM per week
STANDARD_DEVIATION 0.62 • n=7 Participants
|
0.43 CSBM per week
STANDARD_DEVIATION 0.68 • n=5 Participants
|
0.36 CSBM per week
STANDARD_DEVIATION 0.64 • n=4 Participants
|
|
Weekly number of SBM
|
2.31 SBM per week
STANDARD_DEVIATION 1.27 • n=5 Participants
|
2.19 SBM per week
STANDARD_DEVIATION 1.13 • n=7 Participants
|
2.45 SBM per week
STANDARD_DEVIATION 1.35 • n=5 Participants
|
2.32 SBM per week
STANDARD_DEVIATION 1.26 • n=4 Participants
|
PRIMARY outcome
Timeframe: During the first 12 weeksPopulation: The ITT analysis set consisting of all randomized (as planned) patients.
This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Overall Complete Spontaneous Bowel Movement (CSBM) Response
|
12.6 Percentage of patients
|
15.0 Percentage of patients
|
8.1 Percentage of patients
|
SECONDARY outcome
Timeframe: Within first 24 hours of treatment initiationPopulation: The ITT analysis set consisting of all randomized (as planned) patients.
This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Occurrence of CSBM Response
|
21.4 Percentage of patients
|
13.0 Percentage of patients
|
13.5 Percentage of patients
|
SECONDARY outcome
Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment PeriodPopulation: The ITT analysis set consisting of all randomized (as planned) patients.
The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)
|
2.25 SBM per week
Interval 1.78 to 2.71
|
2.40 SBM per week
Interval 1.92 to 2.88
|
1.20 SBM per week
Interval 0.74 to 1.66
|
SECONDARY outcome
Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment PeriodPopulation: The ITT analysis set consisting of all randomized (as planned) patients.
The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly. Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea . For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Change From Baseline in Weekly Stool Consistency of SBMs
|
1.56 Units on BSFS
Interval 1.35 to 1.77
|
1.45 Units on BSFS
Interval 1.24 to 1.66
|
0.80 Units on BSFS
Interval 0.6 to 1.0
|
SECONDARY outcome
Timeframe: At Week 12Population: The ITT analysis set consisting of all randomized (as planned) patients.
This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12. PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 \[none of the time or not at all\] to 4 \[all of the time or extremely\]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation. Total PAC-QOL score was averaged from the individual item score.
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder
|
33.0 Percentage of patients
|
31.0 Percentage of patients
|
18.9 Percentage of patients
|
SECONDARY outcome
Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment PeriodPopulation: The ITT analysis set consisting of all randomized (as planned) patients.
The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount). For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Change From Baseline in Weekly Degree of Straining of SBMs
|
-0.90 Units on a scale
Interval -1.03 to -0.77
|
-0.84 Units on a scale
Interval -0.97 to -0.71
|
-0.63 Units on a scale
Interval -0.76 to -0.5
|
SECONDARY outcome
Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment PeriodPopulation: The ITT analysis set consisting of all randomized (as planned) patients.
The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe). For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Change From Baseline in Weekly Abdominal Bloating Score
|
-0.46 Units on a scale
Interval -0.56 to -0.36
|
-0.35 Units on a scale
Interval -0.46 to -0.25
|
-0.30 Units on a scale
Interval -0.4 to -0.2
|
SECONDARY outcome
Timeframe: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment PeriodPopulation: The ITT analysis set consisting of all randomized (as planned) patients.
The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe). For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
Outcome measures
| Measure |
EBX 10
n=103 Participants
Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
EBX 5
n=100 Participants
Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
PLCBO
n=111 Participants
Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
|
|---|---|---|---|
|
Change From Baseline in Weekly Abdominal Discomfort Score
|
-0.37 Units on a scale
Interval -0.48 to -0.27
|
-0.32 Units on a scale
Interval -0.43 to -0.22
|
-0.25 Units on a scale
Interval -0.36 to -0.15
|
Adverse Events
EBX 10/EBX 10
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
EBX 10/PLCBO
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
EBX 5/EBX 5
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
EBX 5/PLCBO
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
PLCBO/EBX 10
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EBX 10/EBX 10
n=65 participants at risk
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
|
EBX 10/PLCBO
n=53 participants at risk
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
|
EBX 5/EBX 5
n=35 participants at risk
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.
|
EBX 5/PLCBO
n=50 participants at risk
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
|
PLCBO/EBX 10
n=110 participants at risk
Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
|
|---|---|---|---|---|---|
|
Infections and infestations
Tonsillitis
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.91%
1/110 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.91%
1/110 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.91%
1/110 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.91%
1/110 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.91%
1/110 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.0%
1/50 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/110 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
Other adverse events
| Measure |
EBX 10/EBX 10
n=65 participants at risk
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
|
EBX 10/PLCBO
n=53 participants at risk
Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
|
EBX 5/EBX 5
n=35 participants at risk
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.
|
EBX 5/PLCBO
n=50 participants at risk
Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
|
PLCBO/EBX 10
n=110 participants at risk
Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
13/65 • Number of events 17 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
3.8%
2/53 • Number of events 12 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.9%
1/35 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
10.0%
5/50 • Number of events 7 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
3.6%
4/110 • Number of events 5 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
9/65 • Number of events 11 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.7%
3/53 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.7%
2/35 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.0%
1/50 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.5%
6/110 • Number of events 9 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Gastrointestinal disorders
Nausea
|
9.2%
6/65 • Number of events 6 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.9%
1/35 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
1.8%
2/110 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.6%
3/65 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
1.9%
1/53 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
6.0%
3/50 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.91%
1/110 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.1%
2/65 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.7%
2/35 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
1.8%
2/110 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
General disorders
Pain
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.7%
2/35 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/110 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
2/65 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
3.8%
2/53 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.9%
1/35 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
8.0%
4/50 • Number of events 4 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
4.5%
5/110 • Number of events 5 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Infections and infestations
Sinusitis
|
4.6%
3/65 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.7%
3/53 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/35 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
6.0%
3/50 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.91%
1/110 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/65 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
1.9%
1/53 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.7%
2/35 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
6.0%
3/50 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.7%
3/110 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/65 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
1.9%
1/53 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.9%
1/35 • Number of events 1 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
8.0%
4/50 • Number of events 5 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
2.7%
3/110 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
|
Nervous system disorders
Headache
|
4.6%
3/65 • Number of events 3 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/53 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
5.7%
2/35 • Number of events 5 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
0.00%
0/50 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
1.8%
2/110 • Number of events 2 • 6 months
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log. Information on AEs was collected at each trial visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER