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Eligibility
for people ages 6–17
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

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, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

Keywords

Functional Constipation in Children Ages 6-17 Years Functional constipation in children Linzess

Eligibility

You can join if…

Open to people ages 6–17

  • 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:

    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 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

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 043 accepting new patients
    Ontario, California, 91762, 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
NCT02559570
Phase
Phase 2
Lead Scientist
Yvette Wild
Study Type
Interventional
Last Updated
December 1, 2016
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