臨床研究等提出・公開システム

Date of registration	Dec. 16, 2024
Last modified on	July. 03, 2026
Trial ID	jRCT2031240558

Scientific Title	ONO-1110-06:A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis
Public Title	ONO-1110-06:Phase IIa study of ONO-1110 in Patients with Hunner Type Interstitial Cystitis

Contact for Scientific Queries	Name	Terasawa Tetsuji
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	JP Clinical Trial Support Desk
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 31, 2025
Actual date of first enrollment		April. 02, 2025
Target sample size		50
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. Japanese (both sexes) 2. Age (at the time of informed consent): 18 years and older 3. Outpatient 4. Patients who are considered capable of understanding the study procedures and completing the pain diary, bladder diary, and questionnaires appropriately by the investigator (sub-investigator) 5. Patients given a diagnosis of HIC by cystoscopy 6. Patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria
	Exclusion Criteria	1. Patients with a history and presence of chemical cystitis 2. Patients with a history of bladder augmentation or radical cystectomy 3. Patients with pain other than HIC that may affect assessments in this study 4. Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study 5. Patients receiving medications for psychiatric disease
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hunner Type Interstitial Cystitis
Intervention(s)		The IMP is administered as follows according to the assigned administration group. - ONO-1110 group: Take ONO-1110 tablets once a day. - Placebo group: Take placebo tablets once daily.
Primary Outcome(s)		Efficacy: Change in weekly mean of average pain score from baseline Safety: Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test
Secondary Outcome(s)		Efficacy Pharmacokinetics

Primary Sponsor	Ono Pharmaceutical Co.,LTD.

Name of Certified Review Board	The Institutional Review Board, The University of Tokyo Hospital
Address	7-3-1 Hongo Bunkyo-ku, Tokyo
Telephone	+81-3-5800-8743
E-Mail	IRBjimu-tokyo@umin.ac.jp
Approval Status	Approval
Date of approval	Dec. 20, 2024

Plan to share IPD	No

Secondary ID(s)	NCT06752603
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
9	July. 03, 2026	(this page)	Changes
8	Mar. 24, 2026	Detail	Changes
7	Dec. 19, 2025	Detail	Changes
6	Sept. 17, 2025	Detail	Changes
5	June. 02, 2025	Detail	Changes
4	April. 10, 2025	Detail	Changes
3	Feb. 06, 2025	Detail	Changes
2	Jan. 06, 2025	Detail	Changes
1	Dec. 16, 2024	Detail

List of change history