Trial Outcomes & Findings for Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C (NCT NCT04166058)
NCT ID: NCT04166058
Last Updated: 2026-01-06
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
381 participants
Primary outcome timeframe
From first dose of study drug until 30 days following last dose of study drug [up to 24 weeks (FC participants) or 52 weeks (IBS-C participants)].
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
FC 72 ug Linaclotide
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks.
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
FC 145 ug Linaclotide
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
IBS-C 145 ug Linaclotide
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
IBS-C 290 ug Linaclotide
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
210
|
73
|
22
|
76
|
|
Overall Study
Number of Participants Treated and Received Placebo in lead-in Study
|
106
|
31
|
2
|
4
|
|
Overall Study
COMPLETED
|
189
|
66
|
20
|
60
|
|
Overall Study
NOT COMPLETED
|
21
|
7
|
2
|
16
|
Reasons for withdrawal
| Measure |
FC 72 ug Linaclotide
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks.
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
FC 145 ug Linaclotide
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
IBS-C 145 ug Linaclotide
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
IBS-C 290 ug Linaclotide
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
1
|
10
|
|
Overall Study
Lost to Follow-up
|
9
|
2
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
|
Overall Study
Non-compliance with study drug
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Baseline characteristics by cohort
| Measure |
FC 72 ug Linaclotide
n=210 Participants
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks.
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
FC 145 ug Linaclotide
n=73 Participants
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
IBS-C 145 ug Linaclotide
n=22 Participants
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
IBS-C 290 ug Linaclotide
n=76 Participants
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 2.96 • n=37 Participants
|
14.2 years
STANDARD_DEVIATION 1.78 • n=56 Participants
|
13.7 years
STANDARD_DEVIATION 2.68 • n=82 Participants
|
12.9 years
STANDARD_DEVIATION 2.98 • n=31 Participants
|
11.89 years
STANDARD_DEVIATION 3.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=37 Participants
|
40 Participants
n=56 Participants
|
15 Participants
n=82 Participants
|
45 Participants
n=31 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=37 Participants
|
33 Participants
n=56 Participants
|
7 Participants
n=82 Participants
|
31 Participants
n=31 Participants
|
166 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
92 Participants
n=37 Participants
|
37 Participants
n=56 Participants
|
8 Participants
n=82 Participants
|
29 Participants
n=31 Participants
|
166 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=37 Participants
|
36 Participants
n=56 Participants
|
14 Participants
n=82 Participants
|
47 Participants
n=31 Participants
|
215 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
3 Participants
n=31 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
59 Participants
n=37 Participants
|
17 Participants
n=56 Participants
|
3 Participants
n=82 Participants
|
19 Participants
n=31 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=37 Participants
|
52 Participants
n=56 Participants
|
18 Participants
n=82 Participants
|
52 Participants
n=31 Participants
|
264 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until 30 days following last dose of study drug [up to 24 weeks (FC participants) or 52 weeks (IBS-C participants)].Population: Safety Population: all participants who received at least 1 dose of study intervention (linaclotide) in this extension study. Number analyzed are participants with data available for analyses of the specific category.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
FC 72 ug Linaclotide
n=210 Participants
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks.
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
FC 145 ug Linaclotide
n=73 Participants
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
IBS-C 145 ug Linaclotide
n=22 Participants
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
IBS-C 290 ug Linaclotide
n=76 Participants
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
TEAE
|
37 Participants
|
15 Participants
|
4 Participants
|
31 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
TESAE
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
FC 72 ug Linaclotide
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
FC 145 ug Linaclotide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IBS-C 145 ug Linaclotide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IBS-C 290 ug Linaclotide
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FC 72 ug Linaclotide
n=210 participants at risk
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks.
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
FC 145 ug Linaclotide
n=73 participants at risk
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
IBS-C 145 ug Linaclotide
n=22 participants at risk
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
IBS-C 290 ug Linaclotide
n=76 participants at risk
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/76 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/76 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/210 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
1.3%
1/76 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/210 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
1.3%
1/76 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Psychiatric disorders
DISRUPTIVE MOOD DYSREGULATION DISORDER
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/76 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/210 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
1.3%
1/76 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
ADENOIDAL HYPERTROPHY
|
0.00%
0/210 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
1.3%
1/76 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL TURBINATE HYPERTROPHY
|
0.00%
0/210 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
1.3%
1/76 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
TONSILLAR HYPERTROPHY
|
0.00%
0/210 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
1.3%
1/76 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
Other adverse events
| Measure |
FC 72 ug Linaclotide
n=210 participants at risk
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks.
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
FC 145 ug Linaclotide
n=73 participants at risk
Functional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study:
Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.
|
IBS-C 145 ug Linaclotide
n=22 participants at risk
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
IBS-C 290 ug Linaclotide
n=76 participants at risk
Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows:
Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
5.7%
12/210 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
6.8%
5/73 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
9.2%
7/76 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
|
Infections and infestations
INFLUENZA
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
5.3%
4/76 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time in follow-up (or mean time participants were followed) was 176.0, 177.0, 373.5, and 369.0 days for FC 72 ug linaclotide, FC 145 ug linaclotide, IBS-C 145 ug linaclotide, and IBS-C 290 ug linaclotide, respectively.
All AEs were coded using MedDRA version 27.1 and 28.0 for FC and IBS-C participants, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER