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Guanylate Cyclase-C Agonist

Long-Term Safety of Linaclotide for Constipation

Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
c) Presence of a large fecal mass in the rectum
Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 to 52 weeks
Awards & highlights

Study Summary

This trial will enroll children who have completed other trials testing the drug linaclotide for constipation or irritable bowel syndrome with constipation. The children will take the drug for 24 or 52 weeks depending on the condition.

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.Check my eligibility
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.See study design
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 a large stool blockage in my rectum.
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I am a woman who can have children and have had negative pregnancy tests.
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I have had painful or hard bowel movements.
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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 am a woman who has started menstruating and agrees to use birth control if sexually active.
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I have had very large stools that could block a toilet.
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I completed Phase 2 or 3 of the LIN-MD study and it's been over 28 days since my last treatment.
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I have had stomach discomfort or pain once a week for 2 months, meeting specific criteria.
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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.
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I weigh at least 18 kg.
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My symptoms improve after I go to the bathroom.
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My stool's appearance has changed recently.
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My bowel movements have become more frequent.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events

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.

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
275,673 Total Patients Enrolled
6 Trials studying Irritable Bowel Syndrome
1,228 Patients Enrolled for Irritable Bowel Syndrome
Ironwood Pharmaceuticals, Inc.Industry Sponsor
41 Previous Clinical Trials
16,897 Total Patients Enrolled
15 Trials studying Irritable Bowel Syndrome
10,416 Patients Enrolled for Irritable Bowel Syndrome
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,363 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
645 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Linaclotide (Guanylate Cyclase-C Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04166058 — Phase 3
Irritable Bowel Syndrome Research Study Groups: 72 μg linaclotide, 145 μg linaclotide, 290 μg linaclotide
Irritable Bowel Syndrome Clinical Trial 2023: Linaclotide Highlights & Side Effects. Trial Name: NCT04166058 — Phase 3
Linaclotide (Guanylate Cyclase-C Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166058 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would fit the parameters to be a test subject for this experiment?

"Individuals that have been diagnosed with constipation-predominant irritable bowel syndrome (IBS-C) and fall within the age range of 6 to 18 may be eligible for this study. Up to 120 participants will be accepted."

Answered by AI

Has the FDA cleared linaclotide at 72 micrograms for use?

"There is strong evidence from multiple clinical trials supporting the safety of 72 μg linaclotide, so it received a score of 3."

Answered by AI

Would this experiment still be effective for elderly participants?

"The target age group for this trial are children aged 6-18 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Medical Ctr for Clin Research /ID# 236911
Paragon Rx Clinical Inc /ID# 234602
Private Practice - Dr. Craig Spiegel /ID# 234545
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

bowel movements come on fast sometimes.
PatientReceived 1 prior treatment
~31 spots leftby Oct 2025