臨床研究等提出・公開システム

Date of registration	April. 20, 2021
Last modified on	May. 19, 2025
Trial ID	jRCT2031210042

Scientific Title	Phase II study of JTE-051 -Dose finding study in patients with interstitial cystitis-
Public Title	Dose finding study of JTE-051

Contact for Scientific Queries	Name	Mitsui Hironori
	Affiliation	Shionogi & Co.,Ltd.
	Address	3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6635-3505
	E-mail	clinicaltrials-info@shionogi.co.jp
Contact for Public Queries	Name	clinical trials information
	Affiliation	Shionogi & Co.,Ltd.
	Address	3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6635-3505
	E-mail	clinicaltrials-info@shionogi.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 31, 2021
Actual date of first enrollment		June. 01, 2021
Target sample size		150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Diagnosed with interstitial cystitis or bladder pain syndrome 2. Japanese patient aged >=20 and <75 at the time of informed consent 3. Satisfied with protocol-defined criteria for NRS average bladder pain score, ICSI score, and daily urinary frequency
	Exclusion Criteria	1. Have been received therapies (e.g., transurethral resection/fulguration, intravesical instillation, or hydrodistension) during protocol-specified period 2. Have history of augmentation cystoplasty, cystectomy or urinary diversion 3. Found to meet protocol-defined conditions determined by screening results (e.g., laboratory tests) 4. Presence of severe hepatic diseases 5. Presence or history within 5 years of malignancy
	Age Minimum	20age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Interstitial Cystitis/Bladder Pain Syndrome
Intervention(s)		JTE-051 or placebo will be administered orally once daily
Primary Outcome(s)		Change from baseline in NRS average bladder pain score

Primary Sponsor	Japan Tobacco Inc.

Name of Certified Review Board	Tokyo Central Clinical Research Ethics Committee
Address	5-11-8 Nishi-nippori, Arakawa-ku, Tokyo
Telephone	+81-3-6779-8166
E-Mail	chi-pr-cirb-tokyo-central@cmicgroup.com
Approval Status	Approval
Date of approval	April. 22, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
15	May. 19, 2025	(this page)	Changes
14	Oct. 21, 2024	Detail	Changes
13	July. 20, 2024	Detail	Changes
12	July. 16, 2024	Detail	Changes
11	May. 09, 2024	Detail	Changes
10	Nov. 09, 2023	Detail	Changes
9	Mar. 17, 2023	Detail	Changes
8	Jan. 22, 2023	Detail	Changes
7	Aug. 09, 2022	Detail	Changes
6	June. 17, 2022	Detail	Changes
5	April. 08, 2022	Detail	Changes
4	Mar. 14, 2022	Detail	Changes
3	Jan. 30, 2022	Detail	Changes
2	June. 14, 2021	Detail	Changes
1	April. 20, 2021	Detail

List of change history