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)



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:6 - 17
Updated:6/14/2018
Start Date:November 1, 2015
End Date:May 29, 2018

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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the
treatment of functional constipation (FC), in children age 6-17 years. This study includes up
to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will
receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid
oral solution.

Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of
linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will
be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.

This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well
as other bowel symptoms of FC.


Inclusion Criteria:

- Patient weighs at least 18 kg (39.7 lbs)

- Patient meets modified Rome III criteria for child/adolescent FC: For at least 2
months before the Screening Visit, the patient 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, at least once per
week, patient meets 1 or more of the following:

- a) History of retentive posturing or excessive volitional stool retention

- b) History of painful or hard bowel movements (BMs)

- c) Presence of a large fecal mass in the rectum

- d) History of large diameter stools that may obstruct the toilet

- e) At least one episode of fecal incontinence per week

- Patient is willing to discontinue any laxatives used before the Pretreatment Visit in
favor of the protocol-permitted rescue medicine

- Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14
days before the randomization day and up to the randomization. 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

- Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing
both the morning and evening assessments for 10 out of the 14 days immediately
preceding the Randomization Visit

Exclusion Criteria:

- Patient meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS):
At least once per week for at least 2 months before the Screening Visit, the patient
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:

- 1. Improvement with defecation

- 2. Onset associated with a change in frequency of stool

- 3. Onset associated with a change in form (appearance) of stool

- Patient 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

- Select medical history or conditions that may be related to other causes of
constipation or may interfere with safety and efficacy analyses

- Patient has required manual or hospital-based disimpaction any time prior to
randomization

- Patient is unable to tolerate the placebo during the Screening Period
We found this trial at
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185 Cambridge Street
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Chapel Hill, North Carolina 27599
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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4650 Sunset Blvd
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Minneapolis, Minnesota 55455
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Philadelphia, Pennsylvania 19134
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4401 Penn Avenue
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593 Eddy Street
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Anaheim, California 92805
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801 7th Avenue
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4800 Sand Point Way NE
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