Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease

JRCT ID: jRCT1080224091

Registered date:11/10/2018

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 02/10/2017
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Observational

Intervention(s)

investigational material(s)
Generic name etc : Budesonide ( Zentacort Capsules 3mg )
INN of investigational material : Budesonide
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investigational material : Oral

Outcome(s)

• Primary Outcome: Adverse event, clinical laboratory tests, efficacy

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: mild to moderate active Crohn's disease in patients
• Exclude criteria: none

Related Information

• Primary Sponsor: ZERIA Pharmaceutical Co., Ltd.
• Secondary ID(s): JapicCTI-184152