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Corticosteroid

Budesonide for Pediatric Ulcerative Colitis

Phase 4

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

Established diagnosis of UC based on clinical history, characteristic endoscopic findings, and histopathology results from biopsies

Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

Study Summary

This trial evaluates whether a new medication is safe and effective to treat ulcerative colitis in kids, while continuing existing treatments.

Who is the study for?

This trial is for kids aged 5-17 with mild to moderate ulcerative colitis, a type of inflammatory bowel disease. They must have specific symptoms and an established diagnosis based on medical history and tests. Kids should weigh over 13.6 kg and can continue their usual oral or rectal anti-inflammatory medication if stable for at least 6 weeks.Check my eligibility

What is being tested?

The study is testing the effectiveness of budesonide extended-release tablets in inducing remission in children with ulcerative colitis. It's a randomized trial comparing two doses of budesonide against a placebo while allowing continued use of standard anti-inflammatory drugs.See study design

What are the potential side effects?

Budesonide may cause side effects like headaches, nausea, abdominal pain, respiratory infections, fatigue, and behavioral changes. Long-term use might affect growth in children or lead to bone density loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ulcerative colitis based on my medical history, colonoscopy, and biopsy results.

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My ulcerative colitis is active but not severe, with symptoms like bleeding, frequent stools, and visible inflammation.

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I have been on the same 5-ASA medication for at least 6 weeks and am willing to stay on it.

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I am between 5 and 17 years old and weigh more than 13.6 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.

Secondary outcome measures

Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56.

Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56.

Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose BudesonideExperimental Treatment1 Intervention

Group II: High Dose BudesonideExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor

262 Previous Clinical Trials

81,958 Total Patients Enrolled

13 Trials studying Ulcerative Colitis

4,175 Patients Enrolled for Ulcerative Colitis

Varsha BhattStudy DirectorBausch Health

8 Previous Clinical Trials

969 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

100 Patients Enrolled for Ulcerative Colitis

Angela BulawskiStudy DirectorBausch Health

2 Previous Clinical Trials

2,343 Total Patients Enrolled

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04314375 — Phase 4

Ulcerative Colitis Research Study Groups: High Dose Budesonide, Low Dose Budesonide, Placebo

Ulcerative Colitis Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT04314375 — Phase 4

Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04314375 — Phase 4

Frequently Asked Questions

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

What conditions can be ameliorated through the use of High Dose Budesonide?

"High Dose Budesonide is an effective remedy for various acute symptoms, including coryza, proteinuria and nasal congestion."

Answered by AI

Are elderly individuals being included in this clinical study?

"This clinical trial has exacting enrollment requirements, with patients invited to participate aged between 5 and 17 years old. 84 trials are conducted exclusively for minors while 361 occur only in seniors over 65."

Answered by AI

Are there any other studies that have addressed the efficacy of High Dose Budesonide?

"Initially trialled in 2007 at the Arthur F Gelb Medical Corporation, High Dose Budesonide has seen 19535 completed studies. Currently, there are 22 active clinical trials being conducted mostly out of Indianapolis, Indiana."

Answered by AI

Has the FDA sanctioned High Dose Budesonide?

"High Dose Budesonide received a rating of 3 due to it being in its final clinical trial phase, which indicates that the treatment has already been deemed safe and approved."

Answered by AI

Are there numerous facilities conducting this medical experiment in the state?

"This medical study is currently running in 4 distinct locations, including Indianapolis, Bronx and Greenville. It would be prudent to select the nearest clinic for your convenience when enrolling in order to avoid unnecessary travel distances."

Answered by AI

How many individuals are participating in this clinical experimentation?

"At present, this trial is no longer recruiting patients. It was first posted on August 1st 2023 and the latest update occurred a week later. Luckily, there are more than 400 trials searching for people with ulcerative colitis and another 22 studies looking to recruit individuals who suffer from High Dose Budesonide."

Answered by AI

Are there any openings left for prospective participants in this research initiative?

"This particular research endeavour is not presently accepting participants. The experiment first went live on August 1st 2023 and was last altered on the 9th of that same month. In lieu of this study, 408 clinical trials for ulcerative colitis are recruiting patients while 22 studies concerning High Dose Budesonide have open enrollment as well."

Answered by AI

What are the eligibility requirements to participate in this research?

"This clinical trial is seeking 70 juvenile patients, aged 5-17 years old, affected by ulcerative colitis. The following requirements must be met for enrolment: contemporary medical history, characteristic endoscopic findings and histopathology results from biopsies; a bodyweight greater than 13.6kg at baseline; active UC of mild or moderate severity with rectal bleeding subscore ≥1, stool frequency subscore ≥1 and an endoscopy subscore ≥1; if on background oral or rectal 5-ASA therapy the dose/formulation has remained unchanged for 6 weeks prior to randomization visit 2 and subject agrees"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

2023. "Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04314375.

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