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    Clinical Trial Results:
    A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants With Functional Constipation (FC) or Irritable Bowel Syndrome With Constipation (IBS-C)

    Summary
    EudraCT number
    		 2019-001955-38
    Trial protocol
    		 HU   BG  
    Global end of trial date
    05 Jun 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2025
    First version publication date
    06 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LIN-MD-66
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04166058
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road , North Chicago, IL , United States, 60064
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000927-PIP01-10
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, or LIN-MD-64 based on the individual study criteria.
    Protection of trial subjects
    Parent/guardian/LAR and/or the caregiver of each subject read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    United States: 370
    Worldwide total number of subjects
    381
    EEA total number of subjects
    4
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    170
    Adolescents (12-17 years)
    209
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a 14 day screening period before Study Day 1.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Subjects who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FC 72 ug Linaclotide
    Arm description
    		 Functional Constipation (FC) subjects who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: Subjects aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks. Subjects 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    linaclotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water. FC subjects (LIN-MD-62 and LIN-MD-64 completers): Subjects whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Subjects whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide. IBS-C subjects (LINMD-63 and LIN-MD-64 completers): Subjects who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Subjects who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg. Subjects who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.

    Arm title
    		 FC 145 ug Linaclotide
    Arm description
    		 Functional Constipation (FC) subjects who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: Subjects 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    linaclotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water. FC subjects (LIN-MD-62 and LIN-MD-64 completers): Subjects whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Subjects whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide. IBS-C subjects (LINMD-63 and LIN-MD-64 completers): Subjects who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Subjects who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg. Subjects who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.

    Arm title
    		 IBS-C 145 ug Linaclotide
    Arm description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) subjects were dosed as follows: Subjects who received ≤ 145 ug linaclotide or placebo in study LIN-MD-63 received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks. Subjects who completed study LIN-MD-64 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    linaclotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water. FC subjects (LIN-MD-62 and LIN-MD-64 completers): Subjects whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Subjects whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide. IBS-C subjects (LINMD-63 and LIN-MD-64 completers): Subjects who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Subjects who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg. Subjects who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.

    Arm title
    		 IBS-C 290 ug Linaclotide
    Arm description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) subjects were dosed as follows: Subjects who completed study LIN-MD-63 received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. Subjects who completed study LIN-MD-64 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    linaclotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water. FC subjects (LIN-MD-62 and LIN-MD-64 completers): Subjects whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Subjects whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide. IBS-C subjects (LINMD-63 and LIN-MD-64 completers): Subjects who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Subjects who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg. Subjects who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.

    Number of subjects in period 1
    		FC 72 ug Linaclotide FC 145 ug Linaclotide IBS-C 145 ug Linaclotide IBS-C 290 ug Linaclotide
    Started
    210
    73
    22
    76
    Completed
    189
    66
    20
    60
    Not completed
    21
    7
    2
    16
         Consent withdrawn by subject
    4
    4
    1
    10
         Physician decision
    2
    -
    -
    2
         Adverse event, non-fatal
    1
    1
    -
    -
         Other
    1
    -
    -
    1
         Pregnancy
    1
    -
    -
    -
         Noncompliance with study drug
    -
    -
    -
    2
         Lost to follow-up
    9
    2
    1
    1
         Lack of efficacy
    2
    -
    -
    -
         Protocol deviation
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FC 72 ug Linaclotide
    Reporting group description
    		 Functional Constipation (FC) subjects who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: Subjects aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks. Subjects 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.

    Reporting group title
    FC 145 ug Linaclotide
    Reporting group description
    		 Functional Constipation (FC) subjects who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: Subjects 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.

    Reporting group title
    IBS-C 145 ug Linaclotide
    Reporting group description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) subjects were dosed as follows: Subjects who received ≤ 145 ug linaclotide or placebo in study LIN-MD-63 received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks. Subjects who completed study LIN-MD-64 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.

    Reporting group title
    IBS-C 290 ug Linaclotide
    Reporting group description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) subjects were dosed as follows: Subjects who completed study LIN-MD-63 received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. Subjects who completed study LIN-MD-64 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.

    Reporting group values
    		 FC 72 ug Linaclotide FC 145 ug Linaclotide IBS-C 145 ug Linaclotide IBS-C 290 ug Linaclotide Total
    Number of subjects
    		 210 73 22 76 381
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.6 ( 2.96 ) 14.2 ( 1.78 ) 13.7 ( 2.68 ) 12.9 ( 2.98 ) -
    Gender categorical
    Units: Subjects
        Female
    		 115 40 15 45 215
        Male
    		 95 33 7 31 166
    Ethnicity (NIH/ OMB)
    Units: Subjects
        Hispanic or Latino
    		 92 37 8 29 166
        Not Hispanic or Latino
    		 118 36 14 47 215
        Unknown or Not Reported
    		 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 0 0 2
        Asian
    		 2 3 0 3 8
        Native Hawaiian or Other Pacific Islander
    		 2 0 0 0 2
        Black or African American
    		 59 17 3 19 98
        White
    		 142 52 18 52 264
        More than one race
    		 3 1 1 1 6
        Unknown or Not Reported
    		 0 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    FC 72 ug Linaclotide
    Reporting group description
    		 Functional Constipation (FC) subjects who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: Subjects aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks. Subjects 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.

    Reporting group title
    FC 145 ug Linaclotide
    Reporting group description
    		 Functional Constipation (FC) subjects who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: Subjects 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.

    Reporting group title
    IBS-C 145 ug Linaclotide
    Reporting group description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) subjects were dosed as follows: Subjects who received ≤ 145 ug linaclotide or placebo in study LIN-MD-63 received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks. Subjects who completed study LIN-MD-64 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.

    Reporting group title
    IBS-C 290 ug Linaclotide
    Reporting group description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) subjects were dosed as follows: Subjects who completed study LIN-MD-63 received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. Subjects who completed study LIN-MD-64 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.

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs).

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs). [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 subject 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. Analysis Population Description: Safety Population
    End point type
    Primary
    End point timeframe
    From first dose of study drug until 30 days following last dose of study drug [up to 24 weeks (FC subjects) or 52 weeks (IBS-C subjects)].
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were performed.
    End point values
    		 FC 72 ug Linaclotide FC 145 ug Linaclotide IBS-C 145 ug Linaclotide IBS-C 290 ug Linaclotide
    Number of subjects analysed
    210
    73
    22
    76
    Units: Subjects
        TEAE
    37
    15
    4
    31
        TESAE
    2
    0
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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
    Adverse event reporting additional description
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1, 28.0
    Reporting groups
    Reporting group title
    FC 72 ug Linaclotide
    Reporting group description
    		 Functional Constipation (FC) participants who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: 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.

    Reporting group title
    FC 145 ug Linaclotide
    Reporting group description
    		 Functional Constipation (FC) participants who completed studies LIN-MD-62 and LIN-MD-64 were dosed as follows: 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.

    Reporting group title
    IBS-C 145 ug Linaclotide
    Reporting group description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows: Participants who received ≤ 145 ug linaclotide or placebo in study LIN-MD-63 received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks. Participants who completed study LIN-MD-64 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.

    Reporting group title
    IBS-C 290 ug Linaclotide
    Reporting group description
    		 Irritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows: Participants who completed study LIN-MD-63 received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. Participants who completed study LIN-MD-64 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.

    Serious adverse events
    		 FC 72 ug Linaclotide FC 145 ug Linaclotide IBS-C 145 ug Linaclotide IBS-C 290 ug Linaclotide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 210 (0.95%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    2 / 76 (2.63%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 210 (0.00%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    MIGRAINE
         subjects affected / exposed
    0 / 210 (0.00%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ADENOIDAL HYPERTROPHY
         subjects affected / exposed
    0 / 210 (0.00%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NASAL TURBINATE HYPERTROPHY
         subjects affected / exposed
    0 / 210 (0.00%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TONSILLAR HYPERTROPHY
         subjects affected / exposed
    0 / 210 (0.00%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    MENTAL STATUS CHANGES
         subjects affected / exposed
    0 / 210 (0.00%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DISRUPTIVE MOOD DYSREGULATION DISORDER
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PYELONEPHRITIS
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FC 72 ug Linaclotide FC 145 ug Linaclotide IBS-C 145 ug Linaclotide IBS-C 290 ug Linaclotide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 210 (6.67%)
    5 / 73 (6.85%)
    0 / 22 (0.00%)
    11 / 76 (14.47%)
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    12 / 210 (5.71%)
    5 / 73 (6.85%)
    0 / 22 (0.00%)
    7 / 76 (9.21%)
         occurrences all number
    14
    5
    0
    9
    Infections and infestations
    INFLUENZA
         subjects affected / exposed
    2 / 210 (0.95%)
    0 / 73 (0.00%)
    0 / 22 (0.00%)
    4 / 76 (5.26%)
         occurrences all number
    2
    0
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jun 2020
    Amendment 1 - include enrollment of pediatric subjects ages 7 – 17 years with IBS-C from lead-in study LIN-MD-64. Revise the dosing for all IBS-C subjects, and provide additional clarification and updates.
    30 Apr 2021
    Amendment 2 - provide LIN-MD-64 completers with IBS-C the option to continue on the same blinded dose they received in the LIN-MD-64 lead-in study, and to provide additional clarification and updates.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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