臨床研究等提出・公開システム

Date of registration	Oct. 11, 2018
Last modified on	Oct. 09, 2024
Trial ID	jRCT1080224091

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

Completion Date or Terminated date	Feb. 27, 2020
Actual Enrolled Number	214
Baseline Characteristics	The baseline patient characteristics of the 214 patients in the safety population are shown. 71.0% (152/214)were male and 29.0% (62/214) were female. Children (under 15 years) were not enrolled, 5.1% (11/214) was 65 years or older.
Participant flow	221 patients were enrolled; case report forms were collected from 220 patients, and 214 patients were evaluated for safety and efficacy.
Adverse events	Adverse drug reactions were reported in 10 of 214 patients in the safety analysis set at the incidence of 4.7%.
Primary Outcome Measures	The incidence of glucocorticoid-related events, as "important identified risk", was 3.3% (7/214 cases). The incidence of hypersensitivity-related events including anaphylaxis, as "important potential risk", was 0.5% (1/214 cases).
Secondary Outcome Measures	[Efficacy] The overall efficacy rate evaluated by physician was 73.4% (157/214 cases).
Brief summary	Based on the results of this survey, the safety profile of this drug in patients with Crohn's disease did not show any tendency to differ from the known safety profile, and there were no adverse drug reactions of new clinical concern.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name	Contact for pharmacovigilance
	Contact Name for Scientific Queries	ZERIA Pharmaceutical Co., Ltd.
	Address	10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo
	Phone Number	+81-3-3663-2362
	E-mail Address	iyakujo@zeria.co.jp

Contact for Public Queries	Name	Contact for pharmacovigilance
	Contact Name for Public Queries	ZERIA Pharmaceutical Co., Ltd.
	Address	10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo
	Phone Number	+81-3-3663-2362
	E-mail Address	iyakujo@zeria.co.jp

Recruitment Status	completed

Date of First Enrolment		Oct. 02, 2017
Target Sample Size		200
Study Type		Observational
Study Design	Study Design	Open-label, Post-marketing surveillance
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	mild to moderate active Crohn's disease in patients
	Exclusion Criteria	none
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Crohn's disease
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
Health Condition(s) Keyword
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Intervention(s) Code
Primary Outcome		Adverse event, clinical laboratory tests, efficacy
Secondary Outcome

Primary Sponsor	ZERIA Pharmaceutical Co., Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB	none
Address of IRB	-
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E-mail Address of IRB
Status of IRB Review	not applicable
Date of Approval by IRB

Secondary ID No.	JapicCTI-184152
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	Oct. 09, 2024	(this page)	Changes
4	June. 07, 2024	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Oct. 18, 2018	Detail	Changes
1	Oct. 11, 2018	Detail

List of change history