Budesonide for Pediatric Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Bausch Health Americas, Inc.

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.

Research Team

Varsha Bhatt

Principal Investigator

Bausch Health

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

See 1 more

Exclusion Criteria

My ulcerative colitis is severe, with a Mayo score over 10.

I have not had infectious colitis or a positive test for it in the last 30 days.

I have had gastrointestinal surgery, but not for appendicitis or hernia. A gallbladder removal over a year ago is okay.

See 4 more

Treatment Details

Interventions

Budesonide (Corticosteroid)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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

Budesonide is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Pulmicort for: