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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 16 July 2019
Main ID:  JPRN-JapicCTI-184152
Date of registration: 11/10/2018
Prospective Registration: No
Primary sponsor: ZERIA Pharmaceutical Co., Ltd.
Public title: Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease
Scientific title: Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease
Date of first enrolment: 01/9/2017
Target sample size: 200
Recruitment status: recruiting
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-184152
Study type:  OBSERVATIONAL
Study design:  Open-label, Post-marketing surveillance  
Phase:  NA
Countries of recruitment
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: ZERIA Pharmaceutical Co., Ltd. Pharmacovigilance   
Address:  iyakujo@zeria.co.jp
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: mild to moderate active Crohn's disease in patients
Exclusion criteria:

Age minimum:
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Intervention name : Budesonide ( Zentacort Capsules 3mg )
INN of the intervention : Budesonide
Dosage And administration of the intervention : Oral
Primary Outcome(s)
Adverse event, clinical laboratory tests, efficacy
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Refer to the information of contact(s)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Institutional Review Board of Jichi Medical collage hospital
Results
Results available:
Date Posted:
Date Completed:
URL:
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