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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 belowSelect...
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.
Select...
I have a large stool blockage in my rectum.
Select...
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.
Select...
My bowel movements have become more frequent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 to 52 weeks
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a large stool blockage in my rectum.I am a woman who can have children and have had negative pregnancy tests.I have had diabetic neuropathy.I have had painful or hard bowel movements.I have had painful or hard bowel movements.You have one or more of the following conditions:I have not had surgery in my abdomen, pelvis, or behind the peritoneum in the last 6 months.My stool's appearance has changed recently.I have celiac disease or a positive test for it without a confirming biopsy.I am a woman who has started menstruating and agrees to use birth control if sexually active.You have a mental health condition that is not well managed or controlled, and it could interfere with your ability to take part in the study.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 very large stools that could block a toilet.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 had surgery that meets specific criteria.I have not had major surgery in the last 30 days.I currently have an anal fissure.I completed Phase 2 or 3 of the LIN-MD study and it's been over 28 days since my last treatment.You are allergic or have a bad reaction to the study treatment or its ingredients, or other similar medications.I have not used any experimental drugs or devices in the last 30 days, except linaclotide.You have a history of not being able to control your bowel movements.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 had cancer other than skin cancer, but it has been in complete remission for over 5 years.I have had my appendix or gallbladder removed in the last 60 days.My condition improves after I go to the bathroom.I experience at least one episode of losing control over bowel movements weekly.I have needed help to relieve severe constipation before or during a hospital stay in the last year.I have had stomach pain since childhood without a known cause.I have had stomach discomfort or pain once a week for 2 months, meeting specific criteria.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.You have one or more of the following conditions:I have a blockage in my intestines.You have a history of holding in bowel movements intentionally or having difficulty passing stool.You have lactose intolerance that causes stomach pain or discomfort, which could make it difficult to evaluate the study accurately.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.I have a large stool blockage in my rectum.My bowel movements have changed in frequency.I weigh at least 18 kg.I weigh at least 18 kg.My symptoms improve after I go to the bathroom.People who took part in the lead-in study must have finished the intervention.My stool's appearance has changed recently.My stool's appearance has changed recently.You have a history of substance abuse, including drug or alcohol addiction.My bowel movements have become more frequent.
Research Study Groups:
This trial has the following groups:- Group 1: 72 μg linaclotide
- Group 2: 145 μg linaclotide
- Group 3: 290 μg linaclotide
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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
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