臨床研究等提出・公開システム

Date of registration	April. 20, 2017
Last modified on	April. 23, 2021
Trial ID	jRCT2080223511

Scientific Title	A Phase III, multicenter, randomized, double-blind, placebo controlled, parallel group study to assess the efficacy and safety of KRP-116D in Japanese patients with interstitial cystisis.
Public Title	Phase III study of KRP-116D

Completion Date or Terminated date	Jan. 18, 2019
Actual Enrolled Number	109
Baseline Characteristics	Japanese patients with Hunner type or non-Hunner type interstitial cystitis
Participant flow	Of the 109 participants with written informed consent, 96 received the study drug; 4 were discontinued and 93 completed the study.
Adverse events	The prevalence of adverse events was 69.4% in the KRP-116D group and 59.6% in the placebo group. There were 2 serious adverse events in the KRP-116D group and 1 serious adverse event in the placebo group. There was no adverse event causing withdraw from the study in the KRP-116D group.
Primary Outcome Measures	The least squares mean of the change from baseline in ICSI at 12 weeks was 5.2 (-6.2 to -4.2) in the KRP-116D group and -3.4 (-4.5 to -2.4) in the placebo group, indicating superiority of the KRP-116D group over the placebo group (p=0.0188).
Secondary Outcome Measures	Compared to placebo group, significant improvements in ICPI and voiding parameters, including micturitions/24 h, voided volume/micturition, and maximum voided volume/micturition, were seen in patients treated with KRP-116D
Brief summary	Efficacy of the KRP-116D compared with placebo was evaluated
Posting of journal publication
Date of the first journal publication of results	Feb. 12, 2021
URL hyperlink(s) related to results and publications	https://pubmed.ncbi.nlm.nih.gov/33580603/

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 Name for Scientific Queries	Kyorin Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	develop@mb.kyorin-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Kyorin Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	develop@mb.kyorin-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		May. 25, 2017
Target Sample Size		90
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, placebo controlled, parallel group study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Diagnosed with IC
	Exclusion Criteria	Patients has complication or past history within 5 years with cancer Patients complicated with urinary tract/genital infection Patients has past history with augmentation cystoplasty or cystectomy
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Interstitial cystitis( IC )
Intervention(s)		investigational material(s) Generic name etc : KRP-116D INN of investigational material : dimethyl sulfoxide Therapeutic category code : 259 Other agents for uro-genital and anal organ Dosage and Administration for Investigational material : 50 mL intravesical instillation once every two weeks control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : 50 mL intravesical instillation once every two weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy Efficacy(O'Leary and Sant's IC symptom index) Questionnaire
Secondary Outcome		safety efficacy Efficacy(O'Leary and Sant's IC problem index, urinary symptom, bladder pain score,etc.), Safety Questionnaire, Symptom dairy, Adverse event and adverse drug reaction

Primary Sponsor	Kyorin Pharmaceutical Co.,LTD
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Tokyo Women's Medical University IRB
Address of IRB	8-1, Kawada-cho,Shinjuku-ku,Tokyo
Phone Number of IRB	+81-3-5269-7839
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	July. 14, 2017

Secondary ID No.	JapicCTI-173566
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
10	April. 23, 2021	(this page)	Changes
9	June. 10, 2020	Detail	Changes
8	May. 24, 2019	Detail	Changes
7	Dec. 17, 2018	Detail	Changes
6	May. 11, 2018	Detail	Changes
5	May. 11, 2018	Detail	Changes
4	Aug. 01, 2017	Detail	Changes
3	Aug. 01, 2017	Detail	Changes
2	April. 20, 2017	Detail	Changes
1	April. 20, 2017	Detail

List of change history