Long-Term Safety of Linaclotide for Constipation

Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests linaclotide, a medication that helps relieve constipation by increasing fluid in the intestines, in children aged 6-17 with constipation issues. Linaclotide is approved for treating certain types of constipation.

Eligibility Criteria

This trial is for children aged 6-17 with Functional Constipation (FC) or Irritable Bowel Syndrome with Constipation (IBS-C) who completed prior studies LIN-MD-62, LIN-MD-63, or LIN-MD-64. They must have specific symptoms like large stools that may block the toilet and infrequent bowel movements without laxatives. Participants need to weigh at least 18 kg and girls of childbearing age must not be pregnant and agree to use contraception.

Inclusion Criteria

I have had painful or hard bowel movements.

My stool's appearance has changed recently.

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

I have a large stool blockage in my rectum.

I weigh at least 18 kg.

Exclusion Criteria

I have had diabetic neuropathy.

I have not had surgery in my abdomen, pelvis, or behind the peritoneum in the last 6 months.

I have celiac disease or a positive test for it without a confirming biopsy.

My thyroid condition is stable, and I've been on the same dose of medication for at least 3 months.

I have a birth defect affecting my anus.

I have had stomach pain since childhood without a known cause.

I have a condition since childhood that significantly affects my learning and understanding.

I have unexplained symptoms like bleeding, anemia, weight loss, or signs of infection.

I have inflammatory bowel disease.

I have not used any experimental drugs or devices in the last 30 days, except linaclotide.

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

I have had bariatric surgery or part of my GI tract removed.

I have cystic fibrosis.

I have been diagnosed with functional abdominal pain since childhood.

I have Down's syndrome or another chromosomal disorder.

I am being fed through a tube.

I have a blockage in my intestines.

I am not pregnant or nursing, nor do I plan to be during the study.

I have had stomach discomfort or pain once a week for 2 months, which gets better or worse with bowel movements, changes in how often I go, or changes in stool appearance.

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

My bowel movements have changed in frequency.

Treatment Details

The study tests the long-term safety of a medication called linaclotide in pediatric patients over a period of either 24 weeks for FC participants or 52 weeks for IBS-C participants. It's an open-label Phase 3 trial, meaning both researchers and participants know what treatment is being given.

3Treatment groups

Active Control

Group I: 72 μg linaclotideActive Control2 Interventions

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

Group II: 145 μg linaclotideActive Control2 Interventions

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

Group III: 290 μg linaclotideActive Control1 Intervention

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

Linaclotide is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Linzess for: