Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Capsule; oral
Capsule; oral
G & L Research, LLC /ID# 250658
Foley, Alabama, United States
Velocity Clinical Research - Phoenix /ID# 266280
Phoenix, Arizona, United States
HealthStar Research of Hot Springs PLLC /ID# 249481
Hot Springs, Arkansas, United States
Applied Research Center of Arkansas /ID# 249764
Little Rock, Arkansas, United States
Advanced Research Center /ID# 249412
Anaheim, California, United States
Change from baseline in the spontaneous bowel movement (SBM) frequency rate (SBMs/week) observed by the primary caregiver during the double-blind study intervention period.
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. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 12-week SBM frequency rate.
Time frame: Baseline to Week 12
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 36 Weeks
Change from baseline in stool consistency observed by the primary caregiver during the double blind study intervention period
The caregiver/parent/guardian/legally authorized representative (LAR) will rate and record in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid.
Time frame: Baseline to Week 12
Change from baseline in straining observed by the primary caregiver during the double-blind study intervention period
The caregiver/parent/guardian/LAR will rate and record in an eDiary the amount of straining they observe when the child passes the BM.
Time frame: Baseline to Week 12
Change from baseline in proportion of days with fecal incontinence during the double-blind study intervention period (for participants who have acquired toileting skills during daytime and nighttime or acquired toileting skills during daytime only)
Each day the caregiver/parent/guardian/LAR will record incidents of fecal incontinence in an eDiary.
Time frame: Baseline to Week 12
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Kindred Medical Institute - Corona /ID# 249485
Corona, California, United States
Medical Ctr for Clin Research /ID# 254386
San Diego, California, United States
Prohealth Research Center /ID# 249420
Doral, Florida, United States
KIDZ Medical Services - Hollywood /ID# 250823
Hollywood, Florida, United States
Nemours Children's Health System /ID# 250881
Jacksonville, Florida, United States
...and 38 more locations