Overview

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
Trial end date:
2018-05-29
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to evaluate dose response of 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. Participants age 6-11 years will receive oral liquid formulation and participants 12-17 years 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forest Laboratories
Forest Laboratories, LLC, an Allergan Affiliate
Collaborator:
Ironwood Pharmaceuticals, Inc.
Treatments:
Linaclotide
Criteria
Inclusion Criteria:

- Participant weighs at least 18 kg (kilograms) (39.7 lbs)

- Participant meets modified Rome III criteria for child/adolescent FC: For at least 2
months before the Screening Visit, the participant 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 faecal 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

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

- Participant 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

- Participant or participant/guardian/legally authorized representative (LAR) or
caregiver is compliant with electronic diary (eDiary) by completing both the morning
and evening assessments for 10 out of the 14 days immediately preceding the
Randomization Visit

Exclusion Criteria:

- Participant 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
participant 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

- Participant 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

- Participant has required manual or hospital-based disimpassion any time prior to
randomization

- Participant is unable to tolerate the placebo during the Screening Period