A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation



Status:Recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:7 - 17
Updated:12/8/2018
Start Date:November 1, 2015
End Date:October 18, 2020
Contact:Clincial Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877-277-8566

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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, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the
treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.

This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.
Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will
receive solid oral capsule formulation. Children ages 7-11 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 IBS-C.


Inclusion Criteria:

- Patient weighs at least 18 kg (39.7 lbs)

- Patient meets Rome III criteria for child/adolescent IBS: at least once per week for
at least 2 months before Screening Visit, the patient 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

- Patient meets modified Rome III criteria for child/adolescent Functional Constipation
(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

- 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 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 disimpaction anytime prior to randomization or
disimpaction during in-patient hospitalization within one year prior to randomization

- Patient is unable to tolerate the placebo during rhe Screening Period
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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Minneapolis, Minnesota 55455
(612) 625-5000
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Philadelphia, Pennsylvania 19134
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Anaheim, California 92805
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Asheboro, North Carolina 27203
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Baltimore, Maryland 21201
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Bardstown, Kentucky 40004
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Boys Town, Nebraska 68010
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Bronx, New York 10461
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Charleston, South Carolina 29414
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6340 Barnes Road
Colorado Springs, Colorado 80922
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Costa Mesa, California 92626
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Edmonton, Alberta
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3023 Hamaker Court
Fairfax, Virginia 22031
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
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319 North Krome Avenue
Homestead, Florida 33030
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Homestead, Florida 33030
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Hot Springs, Arkansas 71913
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6550 Fannin Street
Houston, Texas 77090
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Jackson, Mississippi 39202
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Little Rock, Arkansas 72212
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2600 Redondo Avenue
Long Beach, California 90806
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1952 Long Grove Drive
Mount Pleasant, South Carolina 29464
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185 South Orange Avenue
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109 Crossroads Road
Scottdale, Pennsylvania 15683
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
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Shreveport, Louisiana 71118
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