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.
- Constipation
- Constipation-predominant Irritable Bowel Syndrome (IBS-C)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: 12 Weeks
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Placebo
1 of 4
Linaclotide 72 μg
1 of 4
Linaclotide 290 μg
1 of 4
Linaclotide 145 μg
1 of 4
Experimental Treatment
426 Total Participants · 4 Treatment Groups
Primary Treatment: Linaclotide 145 μg (IBS-C Participants) · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 6 - 17 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Georgia | 50.0% |
| California | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Medical Ctr for Clin Research /ID# 233004 | 50.0% |
| Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 232940 | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
Does this research opportunity extend to young adults?
"According to the inclusion criteria, participants must be between 6 and 17 years old." - Anonymous Online Contributor