Trial Outcomes & Findings for Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation (NCT NCT01007123)
NCT ID: NCT01007123
Last Updated: 2017-03-22
Results Overview
Primary ep W 1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
Baseline, weekly, up to 8 weeks
Results posted on
2017-03-22
Participant Flow
Participant milestones
| Measure |
Elobixibat (A3309) 5 mg
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
Administered once daily for the duration of the study
|
Placebo
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
48
|
47
|
|
Overall Study
COMPLETED
|
42
|
41
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
11
|
6
|
Reasons for withdrawal
| Measure |
Elobixibat (A3309) 5 mg
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
Administered once daily for the duration of the study
|
Placebo
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
7
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
4
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
Baseline characteristics by cohort
| Measure |
Elobixibat (A3309) 5 mg
n=48 Participants
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=47 Participants
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=48 Participants
Administered once daily for the duration of the study
|
Placebo
n=47 Participants
Administered once daily for the duration of the study
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 13 • n=5 Participants
|
48 years
STANDARD_DEVIATION 11 • n=7 Participants
|
46 years
STANDARD_DEVIATION 13 • n=5 Participants
|
50 years
STANDARD_DEVIATION 13 • n=4 Participants
|
48 years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
48 participants
n=5 Participants
|
47 participants
n=4 Participants
|
190 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, weekly, up to 8 weeksPopulation: ITT population
Primary ep W 1
Outcome measures
| Measure |
Elobixibat (A3309) 5 mg
n=46 Participants
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=43 Participants
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=44 Participants
Administered once daily for the duration of the study
|
Placebo
n=46 Participants
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Change From Baseline in Frequency of Spontaneous Bowel Movements
|
2.5 Number of SBMs
Standard Error 0.7
|
4.0 Number of SBMs
Standard Error 0.7
|
5.4 Number of SBMs
Standard Error 0.71
|
1.7 Number of SBMs
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline, weekly and up to 8 weeksPopulation: ITT population
A CSBM responder is defined as per FDA draft guidance for IBS-C: An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment
Outcome measures
| Measure |
Elobixibat (A3309) 5 mg
n=43 Participants
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=42 Participants
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=40 Participants
Administered once daily for the duration of the study
|
Placebo
n=42 Participants
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
|
25 participants
|
27 participants
|
30 participants
|
14 participants
|
SECONDARY outcome
Timeframe: First weekPopulation: ITT population
Outcome measures
| Measure |
Elobixibat (A3309) 5 mg
n=40 Participants
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=39 Participants
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=40 Participants
Administered once daily for the duration of the study
|
Placebo
n=40 Participants
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Time to First Bowel Movement
|
23 hours
Interval 17.0 to 29.0
|
12 hours
Interval 7.0 to 23.0
|
7 hours
Interval 5.0 to 20.0
|
27 hours
Interval 20.0 to 44.0
|
SECONDARY outcome
Timeframe: Baseline, weekly and up to 8 weeksPopulation: ITT population
Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
Outcome measures
| Measure |
Elobixibat (A3309) 5 mg
n=48 Participants
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=47 Participants
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=48 Participants
Administered once daily for the duration of the study
|
Placebo
n=47 Participants
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Stool Consistency Change From Baseline
|
0.91 units on a scale (1-7)
Standard Deviation 0.99
|
1.52 units on a scale (1-7)
Standard Deviation 1.2
|
1.91 units on a scale (1-7)
Standard Deviation 1.3
|
0.66 units on a scale (1-7)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks of treatmentPopulation: ITT population
Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Outcome measures
| Measure |
Elobixibat (A3309) 5 mg
n=48 Participants
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=46 Participants
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=48 Participants
Administered once daily for the duration of the study
|
Placebo
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
LDL/HDL Ratio
|
-0.10 Ratio
Standard Error 0.08
|
-0.27 Ratio
Standard Error 0.09
|
-0.21 Ratio
Standard Error 0.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and during 8 weeks of treatmentPopulation: ITT population
Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
Outcome measures
| Measure |
Elobixibat (A3309) 5 mg
n=48 Participants
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=46 Participants
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=48 Participants
Administered once daily for the duration of the study
|
Placebo
n=47 Participants
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Straining Change From Baseline
|
-0.84 units on a scale (1-5)
Standard Error 0.1
|
-1.13 units on a scale (1-5)
Standard Error 0.1
|
-1.15 units on a scale (1-5)
Standard Error 0.1
|
-0.64 units on a scale (1-5)
Standard Error 0.1
|
Adverse Events
Elobixibat (A3309) 5 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Elobixibat (A3309) 10 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Elobixibat (A3309) 15 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Elobixibat (A3309) 5 mg
n=48 participants at risk
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=47 participants at risk
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=48 participants at risk
Administered once daily for the duration of the study
|
Placebo
n=47 participants at risk
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/48 • From randomization to end of follow-up 14 days after end of treatment
|
2.1%
1/47 • Number of events 1 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/48 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/47 • From randomization to end of follow-up 14 days after end of treatment
|
|
Gastrointestinal disorders
Bleeding colonic diverticulum
|
2.1%
1/48 • Number of events 1 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/47 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/48 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/47 • From randomization to end of follow-up 14 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/48 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/47 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/48 • From randomization to end of follow-up 14 days after end of treatment
|
2.1%
1/47 • Number of events 1 • From randomization to end of follow-up 14 days after end of treatment
|
Other adverse events
| Measure |
Elobixibat (A3309) 5 mg
n=48 participants at risk
Administered once daily for the duration of the study
|
Elobixibat (A3309) 10 mg
n=47 participants at risk
Administered once daily for the duration of the study.
|
Elobixibat (A3309) 15 mg
n=48 participants at risk
Administered once daily for the duration of the study
|
Placebo
n=47 participants at risk
Administered once daily for the duration of the study
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
4/48 • Number of events 4 • From randomization to end of follow-up 14 days after end of treatment
|
6.4%
3/47 • Number of events 3 • From randomization to end of follow-up 14 days after end of treatment
|
12.5%
6/48 • Number of events 6 • From randomization to end of follow-up 14 days after end of treatment
|
2.1%
1/47 • Number of events 46 • From randomization to end of follow-up 14 days after end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
5/48 • Number of events 5 • From randomization to end of follow-up 14 days after end of treatment
|
10.6%
5/47 • Number of events 5 • From randomization to end of follow-up 14 days after end of treatment
|
27.1%
13/48 • Number of events 13 • From randomization to end of follow-up 14 days after end of treatment
|
0.00%
0/47 • From randomization to end of follow-up 14 days after end of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
4/48 • Number of events 4 • From randomization to end of follow-up 14 days after end of treatment
|
4.3%
2/47 • Number of events 2 • From randomization to end of follow-up 14 days after end of treatment
|
6.2%
3/48 • Number of events 3 • From randomization to end of follow-up 14 days after end of treatment
|
2.1%
1/47 • Number of events 1 • From randomization to end of follow-up 14 days after end of treatment
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
4/48 • Number of events 4 • From randomization to end of follow-up 14 days after end of treatment
|
6.4%
3/47 • Number of events 3 • From randomization to end of follow-up 14 days after end of treatment
|
4.2%
2/48 • Number of events 2 • From randomization to end of follow-up 14 days after end of treatment
|
6.4%
3/47 • Number of events 3 • From randomization to end of follow-up 14 days after end of treatment
|
|
Gastrointestinal disorders
Nausea
|
4.2%
2/48 • Number of events 2 • From randomization to end of follow-up 14 days after end of treatment
|
4.3%
2/47 • Number of events 2 • From randomization to end of follow-up 14 days after end of treatment
|
6.2%
3/48 • Number of events 3 • From randomization to end of follow-up 14 days after end of treatment
|
4.3%
2/47 • Number of events 2 • From randomization to end of follow-up 14 days after end of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60