What side effects are associated with this type of intervention?

Common treatments for IBS, including Linaclotide (a Guanylate Cyclase-C Agonist), often have side effects such as diarrhea, abdominal pain, and bloating. Linaclotide specifically can cause diarrhea, which may be severe in some cases. Other treatments like Alosetron, a 5-HT3 antagonist, frequently cause constipation, with some patients experiencing mild to moderate symptoms. Antidiarrheal agents like loperamide can lead to constipation and should be used cautiously. Bile acid sequestrants, used for persistent diarrhea, may cause gastrointestinal side effects including bloating, flatulence, and abdominal discomfort.

What prior FDA approvals exist?

Linaclotide, a Guanylate Cyclase-C Agonist, has been FDA-approved for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C). Another similar drug is Lubiprostone, a chloride channel activator, which is also approved for IBS-C. For IBS with diarrhea (IBS-D), Alosetron, a 5-HT3 antagonist, has been approved, although its use is restricted due to potential severe side effects like ischemic colitis. These drugs represent the primary pharmacologic treatments approved by the FDA for different subtypes of IBS.

What other types of research exist?

Promising novel alternatives to Linaclotide for IBS patients include plecanatide, another guanylate cyclase-C agonist approved for chronic idiopathic constipation, and bile acid sequestrants like colesevelam for IBS-D. Additionally, glucagon-like peptide 1 receptor agonists such as liraglutide have shown potential in treating bile acid diarrhea, which may benefit IBS patients with similar symptoms.

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Guanylate Cyclase-C Agonist

Long-Term Safety of Linaclotide for Constipation

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

b) History of painful or hard BMs

c) Onset associated with a change in form (appearance) of stool

Must not have

k) History of diabetic neuropathy

b) Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit (Visit 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 to 52 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Linaclotide may cause side effects such as diarrhea, stomach pain, gas, bloating, headache, and fatigue. Since it's designed to treat constipation-related conditions, some gastrointestinal discomfort might be expected as part of its action.

Eligibility Criteria

Inclusion Criteria

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

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I have had painful or hard bowel movements.

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My stool's appearance has changed recently.

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

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I have a large stool blockage in my rectum.

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I weigh at least 18 kg.

Exclusion Criteria

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

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I have had diabetic neuropathy.

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

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

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

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I have a birth defect affecting my anus.

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

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

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

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I have inflammatory bowel disease.

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

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

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

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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 Down's syndrome or another chromosomal disorder.

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I am being fed through a tube.

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I have a blockage in my intestines.

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

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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.

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

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My bowel movements have changed in frequency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 to 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment Emergent Adverse Events

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 26Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Irritable Bowel Syndrome (IBS) work through various mechanisms to alleviate symptoms. Linaclotide, a Guanylate Cyclase-C Agonist, increases intestinal fluid secretion and accelerates transit, which helps relieve constipation and abdominal pain in IBS-C patients. Antidiarrheals like loperamide reduce stool frequency and improve consistency by inhibiting peristalsis. Bile acid sequestrants, such as cholestyramine, bind bile acids to reduce diarrhea by decreasing colonic secretion and motility. These treatments are crucial for IBS patients as they target specific symptoms, improving quality of life by managing pain, constipation, and diarrhea effectively.