A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of Linaclotide Administered Orally to Children, Ages 6 to 17 Years, With Functional Constipation (FC)

Phase 3

Completed

Conditions: and painful defecation
Functional Constipation
infrequent
hard stools
10002112

Registration Number: NL-OMON52398

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Age and Weight
1.01. Male and female participants must be ages 6 to 17 years, (inclusive) at
the time the participant provides assent for the study and
parent/guardian/legally authorized representative (LAR) has provided signed
consent
1.02. Participant weighs >=18 kg at the time the participant provides assent and
the parent/guardian/LAR has provided signed consent
2. Type of Participant and Disease Characteristics
2.01. Participants who meet the modified Rome III criteria for Child/Adolescent
FC. For
at least 2 months before the Screening Visit, the participant has had 2 or fewer
defecations (with each defecation occurring in the absence of any laxative,
suppository, or enema use during the preceding 24 hours) in the toilet per week.
In addition, participant meets one or more of the following criteria at least
once
per week for at least 2 months before the screening visit:
• History of retentive posturing or excessive volitional stool retention
• History of painful or hard BMs
• History of large diameter stools that may obstruct the toilet
• Presence of a large fecal mass in the rectum
• At least 1 episode of fecal incontinence per week
2.02. Participant is willing to discontinue any laxatives used before the
Preintervention Visit in favor of the protocol- permitted rescue medicine.
2.03. Participant has an average of fewer than 3 SBMs per week during the 14
days before the randomization day and up to the randomization (including the
morning eDiary assessments reported before administration of first dose of
double-blind study intervention on the randomization day). An SBM is defined as
a BM that occurs in the absence of laxative, enema, or suppository use on the
calendar day of the BM or the calendar day before the BM
2.04. Participant or parent/guardian/LAR or caregiver is compliant with eDiary
requirements by completing both the morning and evening assessments for 10 out
of the 14 days immediately preceding the Randomization Visit
3. Contraceptives
3.01.Female participants of childbearing potential must have a negative serum
pregnancy test at the Screening Visit and a negative urine pregnancy test at
the Randomization Visit prior to dosing.
3.02. Female participants who have had their first menstrual period and are
sexually active must agree to use a reliable form of contraception. Reliable
contraception is defined in Section 10.7.
4. Informed Consent
4.01. Participant must provide written or verbal informed assent and the
parent/guardian/LAR and caregiver must provide written informed consent before
the initiation of any study-specific procedures.
4.02. Participant is able to read and/or understand the assessments in the
eDiary device. If the participant is 6 to 11 years of age and does not meet
this criterion, the interviewer-administered version of the eDiary must be used
and the parent/guardian/LAR or caregiver who will be administering the
interviewer-administered version of the eDiary must undergo training
5. Other
5.01. Participant must have acquired toilet training skills

Exclusion Criteria

1. Medical Conditions
1.01. Participant meets Rome III criteria for Child/Adolescent IBS: At least
once per week for at least 2 months before the Screening Visit, the participant
has experienced abdominal discomfort (an uncomfortable sensation not described
as pain) or pain associated with 2 or more of the following at least 25% of the
time:
a. Improvement with defecation
b. Onset associated with a change in frequency of stool
c. Onset associated with a change in form (appearance) of stool
1.02. Participant reports having more than 1 loose, mushy stool
(eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form
Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on
the p-BSFS) with any SBM that occurred in the absence of laxative use on the
calendar day of the BM or the calendar day before the BM during the 14 days
before the randomization day and up to the randomization (including the morning
eDiary assessments reported before administration of first dose of double-blind
study intervention on the randomization day)
1.03. Participant has a history of non-retentive fecal incontinence
1.04. Participant has (a) fecal impaction at Visit 2 and has failed outpatient
clean-out during the Screening Period (b) fecal impaction at Visit 3.
1.05. Participant has required manual disimpaction any time prior to
randomization
1.06. Participant currently has both unexplained and clinically significant
alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool],
iron deficiency anemia, or any unexplained anemia, or weight loss) and systemic
signs of infection or colitis, or any neoplastic process
1.07. Participant has clinically significant findings on a physical
examination, vital sign assesment, ECG, or clinical laboratory test as
determined by the investigator based on consideration of whether the finding
could represent a safety concern or a condition that would be exclusionary,
could prevent the participant from performing any protocol assessments, or
could confound study assessments.
1.08. Participant has a history of drug or alcohol abuse.
1.09. Participant has any of the following conditions:
a. Celiac disease, or positive serological test for celiac disease and the
condition has not been ruled out by endoscopic biopsy
b. Cystic fibrosis
c. Hypothyroidism that is untreated or treated with thyroid hormone at a dose
that has not been stable for at least 3 months prior to the Screening Visit
d. Down's syndrome or any other chromosomal disorder
e. Active anal fissure (Note: History of anal fissure is not an exclusion)
f. Anatomic malformations (eg, imperforate anus, anal stenosis, anterior
displaced anus)
g. Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral
myopathies, visceral neuropathies)
h. Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis,
tethered cord, spinal cord trauma)
i. Lead toxicity, hypercalcemia
j. Neurodevelopmental disabilities (early-onset, chronic disorders that share
the essential feature of a predominant disturbance in the acquisition of
cognitive, motor, language, or social skills, which has a significant and
continuing impact on the developmental progress of an individual) producing a
cognitive delay that precludes comprehension and comple

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from baseline in 12-week SBM frequency rate (SBMs/week) during the study<br /><br>intervention period</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change from baseline in 12-week stool consistency during the study intervention<br /><br>period<br /><br>Safety and tolerability assessment</p><br>