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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Constipation

In brief

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.

Key facts

Study ID: NCT02559817
Run by: Forest Laboratories
People needed: 101
Starts: 2015-11-01
Expected to finish: 2019-08-30
Last updated by the study team: 2020-12-28

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

HealthStar Research, LLC — Hot Springs, Arkansas, United States
Applied Research Center of Arkansas — Little Rock, Arkansas, United States
Advanced Research Center - Site 069 — Anaheim, California, United States
Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
WCCT Global, LLC — Costa Mesa, California, United States
ACTCA, Inc — Los Angeles, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
Center for Clinical Trials, LLC — Paramount, California, United States
University of California at San Francisco — San Francisco, California, United States
Advanced Medical Research Center — Miami, Florida, United States
Children's Center for Digestive Health Care LLC — Atlanta, Georgia, United States
Sleepcare Clinical Research Institute — Stockbridge, Georgia, United States
Methodist Medical Center — Peoria, Illinois, United States
Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
Heartland Research Associates, LLC — Wichita, Kansas, United States
Willis-Knighton Physician Network — Shreveport, Louisiana, United States
Certified Research Consultants Virgo/Carter Pediatrics — Silver Spring, Maryland, United States
GI Associates and Endoscopy Center — Jackson, Mississippi, United States
Children's Mercy Hospital — Kansas City, Missouri, United States
Boys Town National Research Hospital — Boys Town, Nebraska, United States
Midwest Children Health Research Institute — Lincoln, Nebraska, United States
Midwest Children Health Research Institute — Lincoln, Nebraska, United States
Goryeb Children's Hospital — Morristown, New Jersey, United States
Columbia University Medical Center and Morgan Stanley Children's Hospital of New York — New York, New York, United States
Asheboro Research Associates - Site 022 — Asheboro, North Carolina, United States

Full record on ClinicalTrials.gov

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