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

Recruiting Phase 4 Interventional Study
Ulcerative Colitis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
5 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Bausch Health Americas, Inc. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About 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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Established diagnosis of UC is based on: * Clinical history * Characteristic endoscopic findings * Histopathology results from biopsies * Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline. * Active UC of mild or moderate …
Contacts

Sandra Narain

9082428287

sandra.narain@bauschhealth.com

CONTACT