臨床研究等提出・公開システム

Date of registration	June. 08, 2006
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220253

Scientific Title	A Phase III Study of IPD-1151T in Patients With Interstitial Cystitis
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Taiho Pharmaceutical Co.,Ltd.
	Address	toiawaseCD1@taiho.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Taiho Pharmaceutical Co.,Ltd.
	Address	toiawase@taiho.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, double-blind, placebo-controlled, parallel-group, comparative study.
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1)20 years and older 2)Interstitial cystitis-characteristic findings observed by cystoscope under hydrodistension 3)Stable for 12 weeks and more following hydrodistension of the bladder 4)IC symptom score of 7 and higher at the end of 2-week observation period 5)Pain score including bladder pain of 4 and higher
	Exclusion Criteria
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Interstitial cystitis
Intervention(s)		investigational material(s) Generic name etc : IPD-1151T INN of investigational material : suplatast tosilate Therapeutic category code : 259 Other agents for uro-genital and anal organ Dosage and Administration for Investigational material : IPD-1151T 100 mg capsules was orally administered to the patients 3 times daily for 12 weeks of treatment period. control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : IPD-1151T placebo capsules was orally administered to the patients 3 times daily for 12 weeks of treatment period.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Improvement of IC symptom score and incidence of adverse drug reactions
Secondary Outcome

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.
Secondary Sponsor

Name of Funding Organization	Taiho Pharmaceutical Co.,Ltd.
Name of Research Funding

Name of IRB	-
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-060257
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	July. 15, 2011	Detail	Changes
6	July. 15, 2011	Detail	Changes
5	Dec. 14, 2010	Detail	Changes
4	June. 22, 2010	Detail	Changes
3	June. 19, 2010	Detail	Changes
2	June. 10, 2010	Detail	Changes
1	June. 08, 2006	Detail

List of change history