臨床研究等提出・公開システム

Date of registration	Mar. 02, 2006
Last modified on	Dec. 28, 2020
Trial ID	jRCT2080220212

Scientific Title	A dose-finding study of OPC-6535 in patients with active ulcerative colitis
Public Title	A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Otsuka Pharmaceutical Co., LTD.
	Address	-
	Phone Number	-
	E-mail Address	CL_OPCJ_RDA_Team@otsuka.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Otsuka Pharmaceutical Co., Ltd.
	Address	-
	Phone Number	+81-3-6361-7314
	E-mail Address

Recruitment Status	terminated

Date of First Enrolment		June. 26, 2006
Target Sample Size		160
Study Type		Interventional
Study Design	Study Design	A multicenter, randomized, double-blind, placebo-controlled (in combination with base drug treatment), parallel-arm, dose-comparison study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients with active ulcerative colitis, (2) Age: 18 to less than 65 years (at time of informed consent), (3) Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose, (4) Either inpatient or outpatient
	Exclusion Criteria	-
	Minimum Age	18age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Active ulcerative colitis
Intervention(s)		investigational material(s) Generic name etc : OPC-6535 INN of investigational material : - Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Clinical improvement rate after 8 weeks of study drug administration
Secondary Outcome		efficacy 1. Remission rate 2. Mean change from the baseline in total Disease Activity Index (DAI) score 3. Mean change from the baseline in DAI subscores 4. Mean change from the baseline in total Clinical Activity Index (CAI) score 5. Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score 6. Mean change from the baseline in IBDQ subscale scores 7. Clinical improvement rate after 4 weeks of study drug administration

Primary Sponsor	Otsuka Pharmaceutical Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Institutional Review Board, Shiga University of Medical Science Hospital
Address of IRB	-
Phone Number of IRB	+81-77-548-2111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Mar. 22, 2006

Secondary ID No.	NCT00317356
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-060216
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
10	Dec. 28, 2020	(this page)	Changes
9	Dec. 17, 2018	Detail	Changes
8	Oct. 01, 2009	Detail	Changes
7	Oct. 01, 2009	Detail	Changes
6	May. 21, 2007	Detail	Changes
5	May. 21, 2007	Detail	Changes
4	July. 27, 2006	Detail	Changes
3	July. 27, 2006	Detail	Changes
2	Mar. 02, 2006	Detail	Changes
1	Mar. 02, 2006	Detail

List of change history