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Guanylate Cyclase-C Agonist

Linaclotide for Pediatric Constipation

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of a large fecal mass in the rectum.

History of large diameter stools.

Must not have

Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension and completion of the daily eDiary or other study-related questionnaires. (Note: participants are excluded if the person who will be completing the daily eDiary or other study-related questionnaires meets this criterion.)

Anatomic malformations (e.g., imperforate anus, anal stenosis, anterior displaced anus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

Pivotal Trial

Summary

This trial will assess the safety and effectiveness of Linaclotide for children with functional constipation. Kids will take Linaclotide or placebo for 12 weeks, then switch to Linaclotide for 24 weeks. Medical assessments, tests and questionnaires will be used to check the effect of the treatment.

Who is the study for?

This trial is for children aged 2 to 5 with functional constipation, meeting specific criteria like having fewer than two bowel movements per week without laxatives. They must not have certain conditions like cystic fibrosis or untreated hypothyroidism, and their caregiver must be able to use an eDiary.

What is being tested?

The study tests Linaclotide against a placebo in young children with functional constipation. It's split into two parts: the first part randomly assigns participants to either the drug or placebo for 12 weeks; the second part gives all participants Linaclotide for another 24 weeks.

What are the potential side effects?

Possible side effects of Linaclotide may include diarrhea, abdominal pain, gas, bloating, and possibly allergic reactions. The severity can vary from child to child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a significant blockage in my rectum.

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I have a history of large stools.

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I experience at least one episode of losing control over bowel movements weekly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot understand or fill out daily study forms due to a cognitive delay.

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I have a birth defect affecting my anus.

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I have Down's syndrome or another chromosomal disorder.

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I have inflammatory bowel disease.

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I have a disorder affecting the nerves or muscles of my intestines.

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I have cystic fibrosis.

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I have been diagnosed with functional abdominal pain since childhood.

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I have celiac disease or it's suspected but not confirmed by a biopsy.

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I have a condition affecting my nerves, like spinal issues or neurofibromatosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Change from baseline in stool consistency observed by the primary caregiver during the double blind study intervention period

Change from baseline in straining observed by the primary caregiver during the double-blind study intervention period

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)