Trial Outcomes & Findings for Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) (NCT NCT02559206)
NCT ID: NCT02559206
Last Updated: 2020-04-24
Results Overview
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
759 participants
Primary outcome timeframe
Baseline, up to Week 12
Results posted on
2020-04-24
Participant Flow
A total of 227 of the 759 participants who signed an informed consent form and entered the Pretreatment Period were not randomized into the study, and were identified as pretreatment failures.
Participant milestones
| Measure |
Placebo
Placebo: once daily (QD) for 12 weeks
|
Linaclotide IR 290 μg
Linaclotide immediate release (IR) formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
Linaclotide delayed release formulation 1 (DR1) 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
Linaclotide DR1 300 μg QD for 12 weeks
|
Linaclotide DR2 30 μg
Linaclotide delayed release formulation 2 (DR2) 30 μg QD for 12 weeks
|
Linaclotide DR2 100 μg
Linaclotide DR2 100 μg QD for 12 weeks
|
Linaclotide DR2 300 μg
Linaclotide DR2 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
67
|
67
|
67
|
67
|
66
|
66
|
|
Overall Study
COMPLETED
|
58
|
54
|
58
|
53
|
55
|
53
|
60
|
57
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
9
|
14
|
12
|
14
|
6
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: once daily (QD) for 12 weeks
|
Linaclotide IR 290 μg
Linaclotide immediate release (IR) formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
Linaclotide delayed release formulation 1 (DR1) 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
Linaclotide DR1 300 μg QD for 12 weeks
|
Linaclotide DR2 30 μg
Linaclotide delayed release formulation 2 (DR2) 30 μg QD for 12 weeks
|
Linaclotide DR2 100 μg
Linaclotide DR2 100 μg QD for 12 weeks
|
Linaclotide DR2 300 μg
Linaclotide DR2 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
1
|
5
|
3
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
1
|
3
|
5
|
4
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
3
|
3
|
2
|
5
|
1
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Overall Study
Other Not Specified
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Baseline characteristics by cohort
| Measure |
Placebo
n=66 Participants
Placebo: once daily (QD) for 12 weeks
|
Linaclotide IR 290 μg
n=66 Participants
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 Participants
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=67 Participants
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=67 Participants
Linaclotide DR1 300 μg QD for 12 weeks
|
Linaclotide DR2 30 μg
n=67 Participants
Linaclotide DR2 30 μg QD for 12 weeks
|
Linaclotide DR2 100 μg
n=66 Participants
Linaclotide DR2 100 μg QD for 12 weeks
|
Linaclotide DR2 300 μg
n=66 Participants
Linaclotide DR2 300 μg QD for 12 weeks
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
42.3 years
STANDARD_DEVIATION 12.6 • n=10 Participants
|
47.9 years
STANDARD_DEVIATION 12.8 • n=115 Participants
|
45.2 years
STANDARD_DEVIATION 14.4 • n=6 Participants
|
45.1 years
STANDARD_DEVIATION 13.8 • n=6 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
52 Participants
n=115 Participants
|
62 Participants
n=6 Participants
|
443 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
89 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
21 Participants
n=6 Participants
|
127 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
51 Participants
n=115 Participants
|
45 Participants
n=6 Participants
|
405 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
48 Participants
n=6 Participants
|
344 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
188 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
25 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
145 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
35 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
|
Abdominal Pain
|
6.41 units on a scale
STANDARD_DEVIATION 1.85 • n=5 Participants
|
6.18 units on a scale
STANDARD_DEVIATION 1.77 • n=7 Participants
|
6.20 units on a scale
STANDARD_DEVIATION 1.59 • n=5 Participants
|
6.18 units on a scale
STANDARD_DEVIATION 1.67 • n=4 Participants
|
6.38 units on a scale
STANDARD_DEVIATION 1.82 • n=21 Participants
|
6.07 units on a scale
STANDARD_DEVIATION 1.68 • n=10 Participants
|
6.48 units on a scale
STANDARD_DEVIATION 1.53 • n=115 Participants
|
6.09 units on a scale
STANDARD_DEVIATION 1.68 • n=6 Participants
|
6.25 units on a scale
STANDARD_DEVIATION 1.69 • n=6 Participants
|
|
Complete Spontaneous Bowel Movement (CBSM) Weekly Rate
|
0.29 CBSM/week
STANDARD_DEVIATION 0.56 • n=5 Participants
|
0.34 CBSM/week
STANDARD_DEVIATION 0.61 • n=7 Participants
|
0.35 CBSM/week
STANDARD_DEVIATION 0.56 • n=5 Participants
|
0.22 CBSM/week
STANDARD_DEVIATION 0.46 • n=4 Participants
|
0.27 CBSM/week
STANDARD_DEVIATION 0.54 • n=21 Participants
|
0.35 CBSM/week
STANDARD_DEVIATION 0.62 • n=10 Participants
|
0.31 CBSM/week
STANDARD_DEVIATION 0.61 • n=115 Participants
|
0.33 CBSM/week
STANDARD_DEVIATION 0.56 • n=6 Participants
|
0.31 CBSM/week
STANDARD_DEVIATION 0.57 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to Week 12Population: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 Participants
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 Participants
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=67 Participants
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=67 Participants
Linaclotide DR1 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
|
-1.370 score on a scale
Standard Error 0.241
|
-1.938 score on a scale
Standard Error 0.241
|
-1.667 score on a scale
Standard Error 0.234
|
-1.656 score on a scale
Standard Error 0.240
|
-2.140 score on a scale
Standard Error 0.236
|
PRIMARY outcome
Timeframe: Baseline, up to Week 12Population: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 Participants
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 Participants
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=66 Participants
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=66 Participants
Linaclotide DR1 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
|
-1.370 score on a scale
Standard Error 0.241
|
-1.938 score on a scale
Standard Error 0.241
|
-1.825 score on a scale
Standard Error 0.238
|
-1.669 score on a scale
Standard Error 0.235
|
-1.628 score on a scale
Standard Error 0.239
|
PRIMARY outcome
Timeframe: Baseline, up to Week 12Population: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 Participants
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 Participants
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=67 Participants
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=67 Participants
Linaclotide DR1 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
|
1.115 CSBMs/week
Standard Error 0.285
|
2.107 CSBMs/week
Standard Error 0.286
|
1.163 CSBMs/week
Standard Error 0.278
|
1.414 CSBMs/week
Standard Error 0.283
|
1.776 CSBMs/week
Standard Error 0.279
|
PRIMARY outcome
Timeframe: Baseline, up to Week 12Population: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 Participants
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 Participants
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=66 Participants
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=66 Participants
Linaclotide DR1 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
|
1.115 CSBMs/week
Standard Error 0.285
|
2.107 CSBMs/week
Standard Error 0.286
|
1.275 CSBMs/week
Standard Error 0.282
|
1.019 CSBMs/week
Standard Error 0.278
|
0.869 CSBMs/week
Standard Error 0.282
|
PRIMARY outcome
Timeframe: up to Week 12Population: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with \<4 days of completed eDiary data for that week is not considered a responder for that week.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 Participants
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 Participants
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=67 Participants
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=67 Participants
Linaclotide DR1 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|
|
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Responder
|
14 Participants
|
21 Participants
|
18 Participants
|
17 Participants
|
26 Participants
|
|
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Non-Responder
|
52 Participants
|
45 Participants
|
49 Participants
|
50 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: up to Week 12Population: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with \<4 days of completed eDiary data for that week is not considered a responder for that week.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 Participants
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 Participants
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=66 Participants
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=66 Participants
Linaclotide DR1 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|
|
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Responder
|
14 Participants
|
21 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
|
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Non-Responder
|
52 Participants
|
45 Participants
|
51 Participants
|
50 Participants
|
52 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Linaclotide IR 290 μg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Linaclotide DR1 30 μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Linaclotide DR1 100 μg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Linaclotide DR1 300 μg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Linaclotide DR2 30 μg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Linaclotide DR2 100 μg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Linaclotide DR2 300 μg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=66 participants at risk
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 participants at risk
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 participants at risk
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=67 participants at risk
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=67 participants at risk
Linaclotide DR1 300 μg QD for 12 weeks
|
Linaclotide DR2 30 μg
n=67 participants at risk
Linaclotide DR2 30 μg QD for 12 weeks
|
Linaclotide DR2 100 μg
n=66 participants at risk
Linaclotide DR2 100 μg QD for 12 weeks
|
Linaclotide DR2 300 μg
n=66 participants at risk
Linaclotide DR2 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
1.5%
1/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
|
Infections and infestations
Sepsis
|
1.5%
1/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
1.5%
1/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
Other adverse events
| Measure |
Placebo
n=66 participants at risk
Placebo: QD for 12 weeks
|
Linaclotide IR 290 μg
n=66 participants at risk
Linaclotide IR formulation: 290 μg QD for 12 weeks
|
Linaclotide DR1 30 μg
n=67 participants at risk
Linaclotide DR1 30 μg QD for 12 weeks
|
Linaclotide DR1 100 μg
n=67 participants at risk
Linaclotide DR1 100 μg QD for 12 weeks
|
Linaclotide DR1 300 μg
n=67 participants at risk
Linaclotide DR1 300 μg QD for 12 weeks
|
Linaclotide DR2 30 μg
n=67 participants at risk
Linaclotide DR2 30 μg QD for 12 weeks
|
Linaclotide DR2 100 μg
n=66 participants at risk
Linaclotide DR2 100 μg QD for 12 weeks
|
Linaclotide DR2 300 μg
n=66 participants at risk
Linaclotide DR2 300 μg QD for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
13.6%
9/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
3.0%
2/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
7.5%
5/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
10.4%
7/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
1.5%
1/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
3.0%
2/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
|
Nervous system disorders
Headache
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
1.5%
1/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
3.0%
2/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
6.0%
4/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
1.5%
1/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/67 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
0.00%
0/66 • From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.
- Publication restrictions are in place
Restriction type: OTHER