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Outcome Measures

Primary Outcomes (1)

Change From Baseline (CFB) in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate During the Treatment Period
SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were calculated as \[(total number of SBMs in the analysis period/number of days in the analysis period)\*7\]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at baseline. A positive change from Baseline indicates improvement. Least squares mean (LSM) and standard error (SE) were calculated using analysis of covariance (ANCOVA) method.
Baseline (14-day prior to randomization and up to randomization) to Week 4

Secondary Outcomes (6)

Change From Baseline (CFB) in 4-week Daytime Abdominal Pain
Baseline (14-day prior to randomization) to Week 4
Change From Baseline (CFB) in 4-week Stool Consistency
Baseline (14-day prior to randomization and up to randomization) to Week 4
Change From Baseline (CFB) in 4-week of Severity of Straining
Baseline (14-day prior to randomization and up to randomization) to Week 4
Change From Baseline (CFB) in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment
Baseline (14-day prior to randomization) to Week 4
Change From Baseline (CFB) in 4-week Overall Complete Spontaneous Bowel Movement Frequency Rate (CSBM/Week) During the Treatment Period
Baseline (14-day prior to randomization and up to randomization) to Week 4
+1 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.

Drug: Placebo

LIN Dose A (9 ug or 18 ug)

EXPERIMENTAL

Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.

Drug: LIN Dose A

LIN Dose B (18 ug or 36 ug)

Interventions

PlaceboDrug

Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

Placebo

LIN Dose ADrug

Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

Also known as: LINZESS

Eligibility Criteria

Age6 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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:

Study Sites (62)

HealthStar Research, LLC

Hot Springs, Arkansas, 71913, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Advanced Research Center

Anaheim, California, 92805, United States

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879, United States

WCCT Global, LLC

Costa Mesa, California, 92626, United States

Ark Clinical Research

Long Beach, California, 90806, United States

ACTCA, Inc

Los Angeles, California, 90017, United States

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)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (5)

Placebo

LIN Dose A (9 ug or 18 ug)

LIN Dose B (18 ug or 36 ug)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (62)

MeSH Terms

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

LIN Dose C (36 ug or 72 ug)

LIN 145 µg

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (5)

Placebo

LIN Dose A (9 ug or 18 ug)

LIN Dose B (18 ug or 36 ug)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (62)

MeSH Terms

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

LIN Dose C (36 ug or 72 ug)

LIN 145 µg

You may not qualify if:

Source record

Documents

Locations