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Eligibility
for people ages 7–17
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Irritable Bowel Syndrome With Constipation Irritable Bowel Syndrome with Constipation in children Linzess

Eligibility

You can join if…

Open to people ages 7–17

  • 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:

    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 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:

    1. History of retentive posturing or excessive volitional stool retention
    2. History of painful or hard bowel movements (BMs)
    3. Presence of a large fecal mass in the rectum
    4. 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 CAN'T join 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 or hospital-based disimpaction any time prior to randomization
  • Patient is unable to tolerate the placebo during rhe Screening Period

Locations

  • Forest Investigative Site 026 in progress, not accepting new patients
    Ventura, California, 93003, United States
  • Forest Investigative Site 015 not yet accepting patients
    Los Angeles, California, 90027, United States
  • Forest Investigative Site 019 in progress, not accepting new patients
    Los Angeles, California, 90017, United States
  • Forest Investigative Site 062 accepting new patients
    Paramount, California, 90723, United States
  • Forest Investigative Site 045 not yet accepting patients
    Los Angeles, California, 90095, United States
  • Forest Investigative Site 069 accepting new patients
    Anaheim, California, 92805, United States
  • Forest Investigative Site 064 accepting new patients
    Costa Mesa, California, 92626, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Forest Laboratories, LLC, an Allergan Affiliate
ID
NCT02559817
Phase
Phase 2
Study Type
Interventional
Last Updated
December 1, 2016
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