Trial Outcomes & Findings for A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC) (NCT NCT02559570)
NCT ID: NCT02559570
Last Updated: 2019-06-19
Results Overview
SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were calculated as \[(total number of SBMs in the analysis period/number of days in the analysis period)\*7\]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at baseline. A positive change from Baseline indicates improvement. Least squares mean (LSM) and standard error (SE) were calculated using analysis of covariance (ANCOVA) method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
173 participants
Primary outcome timeframe
Baseline (14-day prior to randomization and up to randomization) to Week 4
Results posted on
2019-06-19
Participant Flow
Pediatric participants aged 6 to 11 years were dosed using a weight-based approach. For participants who weighed \<35 kg, the doses administered corresponded to about 0.25 to 0.5, 0.5 to 1, or 1 to 2 µg/kg. For participants who weighed ≥35 kg, the doses were not to exceed 0.5, 1, or 2 µg/kg.
Participant milestones
| Measure |
Placebo
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN 145 µg
Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
36
|
41
|
39
|
16
|
|
Overall Study
COMPLETED
|
39
|
34
|
39
|
36
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN 145 µg
Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal of Consent
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Other Miscellaneous Reasons
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=36 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=41 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=39 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN 145 µg
n=16 Participants
Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
10.7 years
n=5 Participants
|
10.9 years
n=7 Participants
|
11.0 years
n=5 Participants
|
11.3 years
n=4 Participants
|
14.7 years
n=21 Participants
|
11.3 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
93 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
80 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
131 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
133 Participants
n=10 Participants
|
|
Spontaneous Bowel Movement (SBM) Frequency Rate
|
1.248 SBMs/week
n=5 Participants
|
1.462 SBMs/week
n=7 Participants
|
1.307 SBMs/week
n=5 Participants
|
1.324 SBMs/week
n=4 Participants
|
1.810 SBMs/week
n=21 Participants
|
1.376 SBMs/week
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline (14-day prior to randomization and up to randomization) to Week 4Population: ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.
SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were calculated as \[(total number of SBMs in the analysis period/number of days in the analysis period)\*7\]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at baseline. A positive change from Baseline indicates improvement. Least squares mean (LSM) and standard error (SE) were calculated using analysis of covariance (ANCOVA) method.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=36 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=41 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=39 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate During the Treatment Period
|
2.000 SBMs/week
Standard Error 0.394
|
1.412 SBMs/week
Standard Error 0.422
|
1.814 SBMs/week
Standard Error 0.397
|
2.364 SBMs/week
Standard Error 0.403
|
SECONDARY outcome
Timeframe: Baseline (14-day prior to randomization) to Week 4Population: ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.
The abdominal pain score was measured using 5-point scale. Participants answered the questions, How much did your tummy hurt as: 0=none, 1=a tiny bit, 2=a little, 3=some, and 4=a lot. The 4-week daytime abdominal pain was calculated as the average of nonmissing scores in evening eDiary during the Treatment Period with higher value indicating greater symptom severity. Baseline value was the average of non-missing values collected 14 days before randomization. Change from Baseline was calculated as the daytime abdominal pain score during the 4-week treatment period (i.e. average of non-missing daytime scores during 4-week treatment period) - daytime abdominal pain score at baseline. A negative change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=36 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=41 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=39 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in 4-week Daytime Abdominal Pain
|
-0.291 score on a scale
Standard Error 0.102
|
-0.333 score on a scale
Standard Error 0.108
|
-0.289 score on a scale
Standard Error 0.102
|
-0.171 score on a scale
Standard Error 0.103
|
SECONDARY outcome
Timeframe: Baseline (14-day prior to randomization and up to randomization) to Week 4Population: ITT population-participants who had at least 1 postbaseline entry on BM characteristic that determined occurrences of SBMs (BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was exploratory arm group. Observed-cases approach used. Overall number of participants analyzed = who had data at Baseline and post-baseline.
Participants used 7-point pediatric Bristol Stool Form (p-BSFS) scale to rate stool consistency for each BM in morning and evening eDiary where 1=small hard lumps or balls like pebbles,2=fat sausage shape but lumpy and hard,3=a sausage but with cracks on it,4=sausage or snake, smooth and soft,5=chicken nuggets, soft smooth blobs,6=oatmeal, fluffy mushy pieces,7=milkshake, watery. Scores in 4-week treatment period were calculated by 2 approaches-1) following derivation similar in earlier adult studies, mean of participants non-missing, SBM associated p-BSFS scores during 4-week treatment period (adult derivation),2) observed weighted average of daily p-BSFS scores during that period. Daily p-BSFS score was average of non-missing morning and/or evening assessments of p-BSFS score from SBMs reported by participants on that specific day. Baseline value was based on values collected 14 days before randomization up to randomization. LSM and SE were calculated using ANCOVA method.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=32 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=34 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=34 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in 4-week Stool Consistency
CFB at Week 4 (Adult derivation)
|
0.690 score on a scale
Standard Error 0.174
|
0.641 score on a scale
Standard Error 0.177
|
0.652 score on a scale
Standard Error 0.174
|
1.046 score on a scale
Standard Error 0.172
|
|
Change From Baseline (CFB) in 4-week Stool Consistency
CFB at Week 4 (Weighted average)
|
0.668 score on a scale
Standard Error 0.167
|
0.606 score on a scale
Standard Error 0.170
|
0.594 score on a scale
Standard Error 0.166
|
0.930 score on a scale
Standard Error 0.165
|
SECONDARY outcome
Timeframe: Baseline (14-day prior to randomization and up to randomization) to Week 4Population: ITT population-participants who had at least 1 postbaseline entry on BM characteristic that determined occurrences of SBMs (BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was exploratory arm group. Observed-cases approach used. Overall number of participants analyzed = who had data at Baseline and post-baseline.
Severity of straining was scored on 5-point scale for question-When you pooped, how hard did you push? The score ranges from 0= not hard at all,1= I pushed a tiny bit hard,2= I pushed a little hard,3= I pushed hard,4= I pushed very hard with higher scores indicating more severe straining. Participants recorded degree of straining for each BM in morning and evening eDiary. Data was derived as adult derivation and weighted average. Scores during 4-week treatment period were calculated following two approaches - (1) following derivation similar in earlier adult studies, as mean of participant's non-missing, SBM associated straining scores during 4-week treatment period (adult derivation) and (2) as observed weighted average of daily straining scores during that period. Daily straining score was the average of non-missing morning and/or evening assessments of straining score from the SBMs reported by the participants on that specific day. LSM and SE were calculated using ANCOVA method.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=32 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=34 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=34 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in 4-week of Severity of Straining
CFB at Week 4 (Adult derivation)
|
-0.657 score on a scale
Standard Error 0.145
|
-0.710 score on a scale
Standard Error 0.150
|
-0.778 score on a scale
Standard Error 0.147
|
-0.893 score on a scale
Standard Error 0.145
|
|
Change From Baseline (CFB) in 4-week of Severity of Straining
CFB at Week 4 (Weighted average)
|
-0.656 score on a scale
Standard Error 0.143
|
-0.710 score on a scale
Standard Error 0.149
|
-0.769 score on a scale
Standard Error 0.145
|
-0.855 score on a scale
Standard Error 0.143
|
SECONDARY outcome
Timeframe: Baseline (14-day prior to randomization) to Week 4Population: ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.
Participants recorded their assessment of abdominal bloating in the evening eDiary. Participants answered the question: How big and full did your tummy feel? on a scale, where: 0=none, 1=a tiny bit, 2=a little, 3=medium or 4=very, with a higher score indicating more severe bloating. Baseline value was the average of values collected 14 days before randomization. The 4-week daytime abdominal bloating symptoms were calculated as the average of non-missing scores reported in the evening eDiary during the treatment period. Change from Baseline was calculated as the 4-week daytime abdominal bloating score during the treatment period - daytime abdominal bloating score at baseline. A negative change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=36 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=41 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=39 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment
|
-0.314 score on a scale
Standard Error 0.104
|
-0.266 score on a scale
Standard Error 0.110
|
-0.287 score on a scale
Standard Error 0.104
|
-0.275 score on a scale
Standard Error 0.105
|
SECONDARY outcome
Timeframe: Baseline (14-day prior to randomization and up to randomization) to Week 4Population: ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.
SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. A CSBM was an SBM that was associated with a sense of complete evacuation. Participants recorded their assessment of the sensation of incomplete evacuation for each BM in the morning and evening eDiary. The 4-week overall CSBM frequency rate was calculated as \[total number of CSBMs in the analysis period/number of days in the analysis period\]\*7). Baseline value was based on values collected 14 days before randomization and up to randomization. Change from Baseline was calculated as the CSBM frequency rate during the 4-week treatment period - CSBM frequency rate at baseline. A positive change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=36 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=41 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=39 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in 4-week Overall Complete Spontaneous Bowel Movement Frequency Rate (CSBM/Week) During the Treatment Period
|
1.240 CSBMs/week
Standard Error 0.308
|
0.815 CSBMs/week
Standard Error 0.328
|
1.005 CSBMs/week
Standard Error 0.309
|
1.320 CSBMs/week
Standard Error 0.314
|
SECONDARY outcome
Timeframe: Baseline (14-day prior to randomization) to Week 4Population: Participants from ITT population included all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use) who were randomized following the implementation of fecal incontinence assessment in the protocol (amendment #3).
Participants recorded the presence of incontinence episodes in daytime daily since pre-treatment period (14-day prior to randomization) in the evening eDiary for participants randomized following protocol amendment #3. The 4-week daytime fecal incontinence was calculated as the mean of non-missing participant scores reported in the evening eDiary during the Treatment Period. Baseline value was the average of values collected 14 days before randomization. Change from Baseline was calculated as the 4-week fecal incontinence daytime symptoms during the treatment period - fecal incontinence daytime symptoms at baseline. A negative change from Baseline indicates improvement. No data is reported for LIN 145 μg as it was an exploratory arm group.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=9 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=13 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=10 Participants
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 4-week Fecal Incontinence Daytime Symptoms Based on Evening Assessment
|
-0.028 incontinence episodes
Standard Deviation 0.081
|
-0.025 incontinence episodes
Standard Deviation 0.083
|
-0.009 incontinence episodes
Standard Deviation 0.067
|
0.170 incontinence episodes
Standard Deviation 0.298
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LIN Dose A (9 ug or 18 ug)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
LIN Dose B (18 ug or 36 ug)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LIN Dose C (36 ug or 72 ug)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
LIN 145 µg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=36 participants at risk
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=41 participants at risk
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=39 participants at risk
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN 145 µg
n=16 participants at risk
Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
2.8%
1/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
6.2%
1/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
|
LIN Dose A (9 ug or 18 ug)
n=36 participants at risk
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
|
LIN Dose B (18 ug or 36 ug)
n=41 participants at risk
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN Dose C (36 ug or 72 ug)
n=39 participants at risk
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
LIN 145 µg
n=16 participants at risk
Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
2.8%
1/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
7.3%
3/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
10.3%
4/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
12.5%
2/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
5.1%
2/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
6.2%
1/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
6.2%
1/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
6.2%
1/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
2.8%
1/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
10.3%
4/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
2.8%
1/36 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/41 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
0.00%
0/39 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
6.2%
1/16 • From first dose of study treatment up to Day 30 after the last dose for serious adverse events (SAEs) and from first dose up to Day 1 after the last dose for other adverse events
Safety population included all participants in the randomized population who took at least 1 dose of double-blind study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER