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Guanylate Cyclase-C Agonist
Linaclotide for Pediatric Constipation
Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals must be 6 months to less than 1 year and 11 months old, at the time the legally authorized representative (LAR)/parent/guardian signs the informed consent in alignment with local requirements.
History of large-diameter stools
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 5
Awards & highlights
Study Summary
This trial will assess the safety & effectiveness of a new drug, linaclotide, to treat constipation in young children. Participants will be monitored closely to check safety, side effects & treatment efficacy.
Who is the study for?
This trial is for children aged 6 months to less than 2 years with functional constipation. They must meet certain criteria like having a history of hard bowel movements or infrequent defecation, and their parents must be able to use an eDiary for tracking. Children with conditions like celiac disease, cystic fibrosis, untreated hypothyroidism, chromosomal disorders, or any condition affecting drug absorption cannot participate.Check my eligibility
What is being tested?
The study tests Linaclotide against a placebo in treating pediatric functional constipation. Initially, different dosages are given consecutively in three groups; later participants are randomly assigned to either the drug or placebo. The treatment involves daily oral solution intake over four weeks at various global sites.See study design
What are the potential side effects?
Possible side effects of Linaclotide may include diarrhea, abdominal pain, gas, bloating and possibly allergic reactions. Since this is a pediatric trial involving very young children, close monitoring for any adverse effects will be essential.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 6 months and less than 2 years old.
Select...
I have a history of large stools.
Select...
I have a large stool blockage in my rectum.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in overall Spontaneous Bowel Movement (SBM) frequency rate (SBMs/week) during the Study Intervention Period
Change from baseline in stool consistency (Bristol Stool Form Scale) during the Study Intervention Period
Change from baseline in straining during the Study Intervention Period
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part 2, PlaceboExperimental Treatment1 Intervention
Participants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks.
Group II: Part 2, LinaclotideExperimental Treatment1 Intervention
Participants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks.
Group III: Part 1, Linaclotide Dose CExperimental Treatment1 Intervention
Linaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks
Group IV: Part 1, Linaclotide Dose BExperimental Treatment1 Intervention
Linaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks
Group V: Part 1, Linaclotide Dose AExperimental Treatment1 Intervention
Linaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Linaclotide
2008
Completed Phase 4
~9200
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,354 Total Patients Enrolled
4 Trials studying Constipation
739 Patients Enrolled for Constipation
Ironwood Pharmaceuticals, Inc.Industry Sponsor
41 Previous Clinical Trials
16,999 Total Patients Enrolled
26 Trials studying Constipation
13,971 Patients Enrolled for Constipation
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,068 Total Patients Enrolled
2 Trials studying Constipation
554 Patients Enrolled for Constipation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The person filling out the eDiary for me can read, understand it, and will be trained.I have celiac disease or it's suspected but not confirmed by a biopsy.I have cystic fibrosis.My thyroid condition is stable and has been treated consistently for the last 3 months.I have Down's syndrome or another chromosomal disorder.I have an active anal fissure with symptoms like blood in stool and pain during bowel movements.I have a birth defect affecting my anus.I have a condition affecting my nerves, like spinal issues or neurofibromatosis.I had cancer before, but it is now in complete remission.I meet the criteria for functional constipation based on my symptoms.You have bowel movements less than two times a week without using any medications to help you go to the bathroom in the past day.You have a history of purposely holding in your bowel movements for too long.I have a history of large stools.My guardian or I agree to stop current laxatives for the study's approved treatment.I have a disorder affecting the nerves or muscles of my intestines.You have lactose intolerance that causes symptoms which may affect the accuracy of the study's assessments.I have inflammatory bowel disease.I do not have conditions like short bowel syndrome that could affect drug absorption.My child is between 6 months and less than 2 years old.I have a large stool blockage in my rectum.I have experienced painful or hard bowel movements.To provide an accurate summary, I would need more information regarding the specific history criteria you are referring to.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1, Linaclotide Dose C
- Group 2: Part 1, Linaclotide Dose A
- Group 3: Part 2, Placebo
- Group 4: Part 1, Linaclotide Dose B
- Group 5: Part 2, Linaclotide
Awards:
This trial has 0 awards, including: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.
Has the FDA accorded its stamp of approval to Linaclotide Dose A in Part 1?
"Linaclotide Dose A in Part 1 of the trial has been assessed to have a safety score of 2 due to limited evidence demonstrating its efficacy, and some data that supports it is safe."
Answered by AI
How many healthcare facilities are currently participating in this research endeavor?
"The primary research centres for this study are Advanced Research Center /ID# 248763 in Anaheim, California, Kindred Medical Institute - Corona /ID# 251535 in Corona, Florida and Prohealth Research Center /ID# 248696 in Doral, Maryland. In addition to these three sites there is also recruitment being conducted at 30 other medical facilities."
Answered by AI
Is this research accessible to minors?
"To be included in this clinical trial, the age of potential participants must fall within the window of 6 Months to 23 Months. There are 26 studies for children and 56 studies targeting seniors."
Answered by AI
Is enrollment still open for this research project?
"Evidently, the clinical trial is no longer accepting patients as indicated by information on clinicaltrials.gov. Originally posted on April 10th 2023 and last edited February 27th of the same year, this study has since been superseded by 81 other studies currently in recruitment mode."
Answered by AI
Is there a criteria for eligibility to partake in this clinical research?
"This clinical trial is seeking 30 participants who suffer from constipation and are between 6 months old to 2 years of age."
Answered by AI
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