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Guanylate Cyclase-C Agonist
Plecanatide for Irritable Bowel Syndrome with Constipation (IBS-C) in Children ((IBS-C) Trial)
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 up to 5 years
Summary
This trial studied whether Plecanatide is an effective and safe treatment for children with IBS-C.
Eligible Conditions
- Irritable Bowel Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2015 Phase 3 trial • 1410 Patients • NCT021224713%
Diarrhoea
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Plecanatide 3 mg
Plecanatide 6 mg
Placebo
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
~10840
Find a Location
Who is running the clinical trial?
Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,720 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant or breastfeeding.You have difficulty moving or exercising normally according to the doctor's evaluation.You have certain medical conditions that make you more likely to have constipation, such as anorectal malformations or neurological deficits.Your sibling is currently or has previously been a part of another Synergy study.The patient's mental age is estimated to be under 4 years old by the investigator.The participant meets the diagnostic criteria for child/adolescent IBS-C according to ROME IV guidelines.
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.
Research Study Groups:
This trial has the following groups:- Group 1: 0.5 mg plecanatide
- Group 2: Matching placebo
- Group 3: 1.0 mg plecanatide
- Group 4: 2.0 mg plecanatide
- Group 5: 3.0 mg plecanatide
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