NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	ulcerative colitis
Date of first enrollment	14/11/2014
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : AJG511 INN of investigational material : budesonide Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : intrarectal control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : intrarectal

Outcome(s)

Primary Outcome	Complete mucosal healing rate
Secondary Outcome	remission rate

Key inclusion & exclusion criteria

Age minimum	>= 16age old
Age maximum	Not applicable
Gender	Both
Include criteria	<Main inclusion criteria> Patients with active ulcerative colitis
Exclude criteria	<Main exclusion criteria> Patients with a history of allergic reaction to budesonide