A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis

NCT ID: NCT06752603

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hunner Type Interstitial Cystitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ONO-1110 ONO-1110-06 Hunner Type Interstitial Cystitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ONO-1110

ONO-1110 tablets once a day

Group Type EXPERIMENTAL

ONO-1110

Intervention Type DRUG

ONO-1110 tablets once a day

Placebo

Placebo tablets once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ONO-1110

ONO-1110 tablets once a day

Intervention Type DRUG

Placebo

Placebo tablets once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Japanese (both sexes)
* Age (at the time of informed consent): 18 years and older
* Outpatient
* 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)
* Patients given a diagnosis of HIC by cystoscopy
* Patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria

Exclusion Criteria

* Patients with a history and presence of chemical cystitis
* Patients with a history of bladder augmentation or radical cystectomy
* Patients with pain other than HIC that may affect assessments in this study
* Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
* Patients receiving medications for psychiatric disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Harasanshin Hospital

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Site Status RECRUITING

Japanese Red Cross Gifu Hospital

Gifu, Gifu, Japan

Site Status RECRUITING

Kurosawa Hospital Health Park Clinic

Takasaki, Gunma, Japan

Site Status RECRUITING

Niimura Hospital

Kagoshima, Kagoshima-ken, Japan

Site Status RECRUITING

Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan

Site Status RECRUITING

Rakuwakai Marutamachi Hospital

Kyoto, Kyoto, Japan

Site Status RECRUITING

Ueda Clinic

Kyoto, Kyoto, Japan

Site Status RECRUITING

Izumi Chuo Hospital

Sendai, Miyagi, Japan

Site Status RECRUITING

Shinshu University Hospital

Matsumoto, Nagano, Japan

Site Status RECRUITING

Nakamura Hospital

Beppu, Oita Prefecture, Japan

Site Status RECRUITING

Okayama University Hospital

Okayama, Okayama-ken, Japan

Site Status RECRUITING

Nanri Urological Clinic

Saga, Saga-ken, Japan

Site Status RECRUITING

The Jikei University Hospital

Minato-Ku, Tokyo, Japan

Site Status RECRUITING

Kyorin University Hospital

Mitaka, Tokyo, Japan

Site Status RECRUITING

The University Of Tokyo Hospital

Tokyo, Tokyo, Japan

Site Status RECRUITING

Toyama Rosai Hospital

Uozu, Toyama, Japan

Site Status RECRUITING

University Of Yamanashi Hospital

Chūō, Yamanashi, Japan

Site Status RECRUITING

Nagasaki University Hospital

Nagasaki, , Japan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

North America Clinical Trial Support Desk

Role: CONTACT

Phone: +18665877745(Toll-Free)

Email: [email protected]

International Clinical Trial Support Desk

Role: CONTACT

Phone: +17162141777(Standard)

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

jRCT2031240558

Identifier Type: REGISTRY

Identifier Source: secondary_id

ONO-1110-06

Identifier Type: -

Identifier Source: org_study_id