Your session is about to expire
← Back to Search
Guanylate Cyclase-C Agonist
Linaclotide for Pediatric Irritable Bowel Syndrome and 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
Female participants of childbearing potential must have negative pregnancy tests
Participant weighs ≥18 kg at the time the participant provides assent and the parent/guardian/LAR has provided signed consent;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a drug called linaclotide to see if it is safe and effective in treating children with constipation or irritable bowel syndrome.
Who is the study for?
This trial is for kids aged 6-17 with Functional Constipation (FC) and those aged 7-17 with Irritable Bowel Syndrome with Constipation (IBS-C), meeting specific criteria like having fewer bowel movements than normal. They must weigh at least 18 kg, have toilet training skills, and not be on any excluded medications or treatments.Check my eligibility
What is being tested?
The study tests Linaclotide at different doses (72 μg for FC, 145 μg or 290 μg for IBS-C) against a placebo over a period of 12 weeks to see if it's safe and effective in improving bowel movement frequency and abdominal pain in children.See study design
What are the potential side effects?
Linaclotide may cause side effects such as diarrhea, stomach pain, gas, bloating, headache or dizziness. These are generally mild but can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and my pregnancy test is negative.
Select...
I weigh at least 18 kg and have consent from my guardian.
Select...
I weigh at least 18 kg.
Select...
I am between 6 and 17 years old, depending on my condition.
Select...
I am willing to stop taking any laxatives before the Preintervention Visit.
Select...
You have a history of holding in bowel movements, having painful or large bowel movements, or experiencing fecal incontinence at least once a week. You may also have a large mass of stool in your rectum that could cause toilet blockages.
Select...
I have less than 3 bowel movements a week without using laxatives.
Select...
I have had some abdominal pain almost every day for the last two weeks.
Select...
I have had 2 or fewer bowel movements per week for the last 2 months without using laxatives.
Select...
I am between 6 and 17 years old, or my child is, and consent for the study has been given.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Constipation (FC) Participants: Change from baseline in 12-week SBM (spontaneous bowel movement) frequency rate (SBMs/week) during the study intervention period
Irritable Bowel Syndrome with Constipation (IBS-C) Participants: 6/12 weeks APS (abdominal pain and SBM) + 2 responder
Secondary outcome measures
Functional Constipation (FC) Participants: Change from baseline in 12-week stool consistency during the study intervention period
Irritable Bowel Syndrome with Constipation (IBS-C) Participants: 6/12 weeks SBM + 2 responder
Irritable Bowel Syndrome with Constipation (IBS-C) Participants: 6/12 weeks abdominal pain responder
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
FC Participants: Single dose, once daily at approximately the same time each day, 30 minutes before any meal
Group II: Linaclotide 72 μgExperimental Treatment1 Intervention
FC Participants: Single dose, once daily at approximately the same time each day, 30 minutes before any meal
Group III: Linaclotide 290 μgExperimental Treatment1 Intervention
IBS-C Participants: Single dose, once daily at approximately the same time each day, 30 minutes before any meal
Group IV: Linaclotide 145 μgExperimental Treatment1 Intervention
IBS-C Participants: Single dose, once daily at approximately the same time each day, 30 minutes before any meal
Find a Location
Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,131 Total Patients Enrolled
2 Trials studying Constipation
155 Patients Enrolled for Constipation
Ironwood Pharmaceuticals, Inc.Industry Sponsor
41 Previous Clinical Trials
16,591 Total Patients Enrolled
26 Trials studying Constipation
13,563 Patients Enrolled for Constipation
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,821 Total Patients Enrolled
1 Trials studying Constipation
120 Patients Enrolled for Constipation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, nursing, nor planning to become pregnant or nurse during the study.I have significant health issues found during a physical exam or tests.I am a woman who can have children and my pregnancy test is negative.I feel better after going to the bathroom.You have a history of not being able to control bowel movements.I weigh at least 18 kg and have consent from my guardian.I am willing to stop my current laxatives for the study's approved treatment.I weigh at least 18 kg.I've had loose or watery stools more than once in the last 14 days.You are allergic to the study drug or other medicines in the same category.I am between 6 and 17 years old, depending on my condition.I have needed help to relieve severe constipation before joining the study.I am willing to stop taking any laxatives before the Preintervention Visit.You have a history of holding in bowel movements, having painful or large bowel movements, or experiencing fecal incontinence at least once a week. You may also have a large mass of stool in your rectum that could cause toilet blockages.My stool's appearance has changed recently.I have less than 3 bowel movements a week without using laxatives.I have had an average daily stomach pain score of 1 or more.I have had less than 3 bowel movements per week in the last 2 weeks.I have had surgery that fits the specific criteria listed.I have had some abdominal pain almost every day for the last two weeks.You have a health condition that may prevent you from completing or participating in the study.You have a health condition or situation that might make it difficult or risky for you to participate in the study or affect the accuracy of the results.You have one of the medical conditions listed below.I have been diagnosed with fecal impaction recently.I have serious symptoms that don't have an obvious cause.I have not used any medicines that are not allowed in the study.You have a history of taking drugs or drinking too much alcohol.I may have a blockage in my intestines.I have had 2 or fewer bowel movements per week for the last 2 months without using laxatives.I have had issues with bowel movements, like pain, large stools, or accidents, weekly for 2 months.I am between 6 and 17 years old, or my child is, and consent for the study has been given.I am using reliable birth control methods.I used emergency medication the day before and on the day I joined the study.My bowel movements have become more or less frequent.I have been diagnosed with IBS-C as a child or adolescent.
Research Study Groups:
This trial has the following groups:- Group 1: Linaclotide 72 μg
- Group 2: Placebo
- Group 3: Linaclotide 145 μg
- Group 4: Linaclotide 290 μg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Constipation Patient Testimony for trial: Trial Name: NCT04026113 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being accepted into the program?
"This study, as indicated by clinicaltrials.gov, is still recruiting patients. The trial was originally advertised on October 1st 2019 with the most recent update being November 9th 2022."
Answered by AI
What other tests involving Linaclotide 145 μg have been done with patients who suffer from IBS-C?
"Linaclotide 145 μg (IBS-C Participants) was first studied in 2015 at Texas Tech University Health Sciences Center. To date, a total of 27 studies have been completed, with 3 more trials currently underway. Many of these trials are based out of Plano, Texas."
Answered by AI
What is the focus of this research?
"The main objective of this study is to assess the effectiveness of a new medication for treating Irritable Bowel Syndrome with Constipation (IBS-C). The study will last for 12 weeks, and participants will be asked to keep track of their bowel movements using an electronic diary. Secondary objectives include measuring changes in stool consistency and frequency of bowel movements over the course of the study."
Answered by AI
Could I join the ranks of this clinical trial?
"This clinical trial is seeking 426 patients aged 6-17 that suffer from irritable bowel syndrome. The criteria for applicants are as follows: The child must be of the appropriate age range, have a body weight of at least 18kg, meet the Rome III criteria for FC, have experienced no more than 2 defecations per week, show improvement with defecation, and be willing to discontinue use of laxatives. For IBS-C participants specifically, they must also have an average daytime abdominal pain score of 1 or higher."
Answered by AI
Are there any dangers associated with Linaclotide 145 μg (IBS-C Participants)?
"The safety of Linaclotide 145 μg has been well documented in prior Phase 3 trials, and it thus receives a score of 3."
Answered by AI
Are there any participating hospitals in North America?
"This study is running at AIM Trials /ID# 232934 in Plano, Texas, David M. Headley, MD, P.A. /ID# 233153 in Port Gibson, Mississippi, and GI associates and Endoscopy Ce /ID# 233123 in Flowood, Oklahoma as well as other sites 73 other locations."
Answered by AI
How many patients have signed up to participate in this clinical trial?
"Yes, the trial is ongoing and recruiting patients. According to clinicaltrials.gov, this study was first posted on October 1st, 2019 and was last updated November 9th, 2020. They are looking for 426 participants at 73 different sites."
Answered by AI
Does this research opportunity extend to young adults?
"According to the inclusion criteria, participants must be between 6 and 17 years old."
Answered by AI
Who else is applying?
What state do they live in?
California
Kentucky
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
Medical Ctr for Clin Research /ID# 233004
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 232940
Clinical Trials Specialist Inc /ID# 232802
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
Why did patients apply to this trial?
I've tried a few different things but none really help.
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger