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Guanylate Cyclase-C Agonist

Plecanatide for Irritable Bowel Syndrome with Constipation (IBS-C) in Children ((IBS-C) Trial)

Q: Who does this clinical trial target as potential participants?

This study is designed for children aged 6-17 who have been diagnosed with irritable bowel syndrome-- 210 patients in total will be accepted.

Q: Are there other examples of Plecanatide being tested in a clinical setting?

3 clinical trials for Plecanatide are currently underway, 1 of which is in the final Phase 3. These tests are being conducted across 12 different locations, with the majority of them taking place in Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>.

Q: How many total patients are involved in this clinical trial?

Yes, this trial is still looking for patients. According to the information available on clinicaltrials.gov, the study was first posted on 6/30/2018, and was last updated on 1/19/2022. A total of 210 patients are needed at 9 different sites.

Q: Are octogenarians still welcome in this research project?

The target recruitment demographic for this study are individuals who have not yet reached their 18th birthday but are older than 6 years old.

Q: At how many healthcare facilities is this research project currently underway?

To facilitate accessibility, this trial is enrolling patients at 9 sites. 8 of these locations are based in Crowley, Newport News and Miami while the remaining site is located elsewhere.

Q: Are investigators still signing up volunteers for this research project?

The information available on clinicaltrials.gov leads us to believe that this study is still actively recruiting patients. 9 different sites are looking for a total of 210 individuals to participate. The first posting was on 6/30/2018, with the most recent edit taking place on 1/19/2022.

Q: What is the FDA's stance on Plecanatide?

While there is some evidence that Plecanatide is safe, it only received a score of 2 because this drug is still in Phase 2 trials and has not yet been proven effective.

Q: Have other patients undergone this treatment before?

At this moment in time, there are 3 ongoing clinical trials for Plecanatide across 11 cities and 2 countries. The first trial was completed by Bausch Health Americas, Inc. in 2018 and it reached Phase 2 of drug approval. 210 patients were involved. In the years since 2018, 62 more studies have been conducted on the matter.

Phase 2

Recruiting

Research Sponsored by Bausch Health Americas, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 week

Awards & highlights

(IBS-C) Trial Summary

This trial studied whether Plecanatide is an effective and safe treatment for children with IBS-C.

Eligible Conditions

Irritable Bowel Syndrome

(IBS-C) Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 week for reporting.

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 weekly SBM frequency over the 4 Week Treatment Period compared to placebo and across treatment groups

Secondary outcome measures

Change from baseline in frequency and severity of abdominal pain/discomfort

Change from baseline in frequency of BMs and CSBMs

Change from baseline in stool consistency (BSFS or mBSFS-C)

Side effects data

From 2015 Phase 3 trial • 1410 Patients • NCT02122471

Diarrhoea

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Plecanatide 3 mg

Plecanatide 6 mg

(IBS-C) Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: 3.0 mg plecanatideExperimental Treatment1 Intervention

Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old

Group II: 2.0 mg plecanatideExperimental Treatment1 Intervention

Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old

Group III: 1.0 mg plecanatideExperimental Treatment1 Intervention

Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to < 18 years old

Group IV: 0.5 mg plecanatideExperimental Treatment1 Intervention

Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old

Group V: Matching placeboPlacebo Group1 Intervention

Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to < 18 years old

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Plecanatide

2016

Completed Phase 3

~10190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor

262 Previous Clinical Trials

81,818 Total Patients Enrolled

14 Trials studying Irritable Bowel Syndrome

10,023 Patients Enrolled for Irritable Bowel Syndrome

John LaheyStudy DirectorBausch Health

5 Previous Clinical Trials

1,268 Total Patients Enrolled

Media Library

Plecanatide (Guanylate Cyclase-C Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03596905 — Phase 2

Irritable Bowel Syndrome Clinical Trial 2023: Plecanatide Highlights & Side Effects. Trial Name: NCT03596905 — Phase 2

Plecanatide (Guanylate Cyclase-C Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03596905 — Phase 2

Irritable Bowel Syndrome Research Study Groups: 0.5 mg plecanatide, Matching placebo, 1.0 mg plecanatide, 2.0 mg plecanatide, 3.0 mg plecanatide

Frequently Asked Questions

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

Who does this clinical trial target as potential participants?

"This study is designed for children aged 6-17 who have been diagnosed with irritable bowel syndrome-- 210 patients in total will be accepted."

Answered by AI

Are there other examples of Plecanatide being tested in a clinical setting?

"3 clinical trials for Plecanatide are currently underway, 1 of which is in the final Phase 3. These tests are being conducted across 12 different locations, with the majority of them taking place in Houston, Texas."

Answered by AI

How many total patients are involved in this clinical trial?

"Yes, this trial is still looking for patients. According to the information available on clinicaltrials.gov, the study was first posted on 6/30/2018, and was last updated on 1/19/2022. A total of 210 patients are needed at 9 different sites."

Answered by AI

Are octogenarians still welcome in this research project?

"The target recruitment demographic for this study are individuals who have not yet reached their 18th birthday but are older than 6 years old."

Answered by AI

At how many healthcare facilities is this research project currently underway?

"To facilitate accessibility, this trial is enrolling patients at 9 sites. 8 of these locations are based in Crowley, Newport News and Miami while the remaining site is located elsewhere."

Answered by AI

Are investigators still signing up volunteers for this research project?

"The information available on clinicaltrials.gov leads us to believe that this study is still actively recruiting patients. 9 different sites are looking for a total of 210 individuals to participate. The first posting was on 6/30/2018, with the most recent edit taking place on 1/19/2022."

Answered by AI

What is the FDA's stance on Plecanatide?

"While there is some evidence that Plecanatide is safe, it only received a score of 2 because this drug is still in Phase 2 trials and has not yet been proven effective."

Answered by AI

Have other patients undergone this treatment before?

"At this moment in time, there are 3 ongoing clinical trials for Plecanatide across 11 cities and 2 countries. The first trial was completed by Bausch Health Americas, Inc. in 2018 and it reached Phase 2 of drug approval. 210 patients were involved. In the years since 2018, 62 more studies have been conducted on the matter."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

2018. "Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03596905.

All > Irritable Bowel Syndrome > Ibs