Hunner Type Interstitial CystitisPhase 2NCT06752603
A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis
A Phase 2 study testing ONO-1110 in people with Hunner Type Interstitial Cystitis, run by Ono Pharmaceutical Co., Ltd. at 20 sites in Japan.
Trial summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hunner Type Interstitial Cystitis
- What is being tested?
- ONO-1110
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 20 sitesJapan
- Study dates
- 2 Apr 2025to 12 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Nakamura Hospital
Beppu, Oita Prefecture
University Of Yamanashi Hospital
Chūō, Yamanashi
Harasanshin Hospital
Fukuoka, Fukuoka
Fukushima Medical University Hospital
Fukushima, Fukushima
Japanese Red Cross Gifu Hospital
Gifu, Gifu
Niimura Hospital
Kagoshima, Kagoshima-ken
Kanto Rosai Hospital
Kawasaki, Kanagawa
Rakuwakai Marutamachi Hospital
Kyoto, Kyoto
Ueda Clinic
Kyoto, Kyoto
Shinshu University Hospital
Matsumoto, Nagano
The Jikei University Hospital
Minato-Ku, Tokyo
Kyorin University Hospital
Mitaka, Tokyo
Nagasaki University Hospital
Nagasaki
Nagoya University Hospital
Nagoya, Aichi-ken
Okayama University Hospital
Okayama, Okayama-ken
Nanri Urological Clinic
Saga, Saga-ken
Izumi Chuo Hospital
Sendai, Miyagi
Kurosawa Hospital Health Park Clinic
Takasaki, Gunma
The University Of Tokyo Hospital
Tokyo, Tokyo
Toyama Rosai Hospital
Uozu, Toyama
About this study
Official title: 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
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis
- Conditions
- Hunner Type Interstitial Cystitis
- Being tested
- ONO-1110, Placebo
- Keywords
- ONO-1110, ONO-1110-06, Hunner Type Interstitial Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-1110Drug
ONO-1110 tablets once a day
PlaceboDrug
Placebo tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| ONO-1110 | Experimental | ONO-1110 tablets once a day Receives: Drug: ONO-1110 |
| Placebo | Placebo comparator | Placebo tablets once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly mean of average pain score from baseline to Week 12 of the treatment period
Measured: Up to 20 weeks
Adverse events
Measured: Up to 20 weeks
Secondary outcomes (15)
Change in weekly mean of average pain score from baseline in each week
Measured: Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score
proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively
Measured: Up to 20 weeks
Change in weekly mean of worst pain score from baseline to each week
Measured: Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score
proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively
Measured: Up to 20 weeks
Change in Interstitial cystitis symptom index (ICSI) score from baseline
Measured: Up to 20 weeks
Change in Interstitial cystitis problem index (ICPI) score from baseline
Measured: Up to 20 weeks
Change in Average frequency of urination per day from baseline
Measured: Up to 20 weeks
Change in Frequency of nocturnal urination per day from baseline
Measured: Up to 20 weeks
Change in Mean volume voided per micturition in a day from baseline
Measured: Up to 20 weeks
Change in Maximum volume voided per micturition in a day from baseline
Measured: Up to 20 weeks
Change in Number of urgency episodes per day from baseline
Measured: Up to 20 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline
Measured: Up to 20 weeks
Change in SF-12v2 score from baseline
Measured: Up to 20 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
Measured: Up to 20 weeks
Plasma ONO-1110 concentrations
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start2 Apr 2025
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hunner Type Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752603
- Sponsor's protocol ID
- ONO-1110-06
- Other IDs
- jRCT2031240558
- Status last verified
- Jul 2026
- First submitted
- 22 Dec 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06752603
- Acronym / sponsor ID
- ONO-1110-06
- Conditions
- Hunner Type Interstitial Cystitis
- Keywords
- ONO-1110, ONO-1110-06, Hunner Type Interstitial Cystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-1110 | Experimental | Drug: ONO-1110ONO-1110 tablets once a day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-1110ONO-1110 tablets once a day | Drug | ONO-1110 |
| PlaceboPlacebo tablets once daily | Drug | Placebo |
Primary outcome
Change in weekly mean of average pain score from baseline to Week 12 of the treatment period
Time frame: Up to 20 weeks
Adverse events
Time frame: Up to 20 weeks
15 secondary outcomes
Change in weekly mean of average pain score from baseline in each week
Time frame: Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score
Time frame: Up to 20 weeks
Change in weekly mean of worst pain score from baseline to each week
Time frame: Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score
Time frame: Up to 20 weeks
Change in Interstitial cystitis symptom index (ICSI) score from baseline
Time frame: Up to 20 weeks
Change in Interstitial cystitis problem index (ICPI) score from baseline
Time frame: Up to 20 weeks
Change in Average frequency of urination per day from baseline
Time frame: Up to 20 weeks
Change in Frequency of nocturnal urination per day from baseline
Time frame: Up to 20 weeks
Change in Mean volume voided per micturition in a day from baseline
Time frame: Up to 20 weeks
Change in Maximum volume voided per micturition in a day from baseline
Time frame: Up to 20 weeks
Change in Number of urgency episodes per day from baseline
Time frame: Up to 20 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline
Time frame: Up to 20 weeks
Change in SF-12v2 score from baseline
Time frame: Up to 20 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
Time frame: Up to 20 weeks
Plasma ONO-1110 concentrations
Time frame: Up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hunner Type Interstitial Cystitis
RecruitingPhase 2/3
The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions
IC, Hunner Type Interstitial Cystitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-1110 in people with Hunner Type Interstitial Cystitis, run by Ono Pharmaceutical Co., Ltd. at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly mean of average pain score from baseline to Week 12 of the treatment period (time frame: Up to 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.