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New bladder pain pill shows promise in early trial

NCT ID NCT06752603

Symptom relief Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether a once-daily tablet called ONO-1110 can safely reduce bladder pain in people with Hunner type interstitial cystitis, a painful bladder condition. About 50 Japanese adults will receive either the drug or a placebo for 12 weeks. The main goal is to see if pain scores improve compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ONO-1110 (tablet taken once daily)
What this could lead to
If successful, this could point toward a new daily pill to ease chronic bladder pain in people with Hunner type interstitial cystitis.
What could go wrong
This is an early Phase 2 trial with only 50 participants in Japan, so results may not apply to other groups. The drug may not reduce pain better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

57 people

The number who actually took part.

Started

Apr 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

interstitial cystitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hunner type interstitial cystitis

Contacts and locations

Locations

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, Japan

  • Harasanshin Hospital

    Fukuoka, Fukuoka, Japan

  • Izumi Chuo Hospital

    Sendai, Miyagi, Japan

  • Japanese Red Cross Gifu Hospital

    Gifu, Gifu, Japan

  • Kanto Rosai Hospital

    Kawasaki, Kanagawa, Japan

  • Kurosawa Hospital Health Park Clinic

    Takasaki, Gunma, Japan

  • Kyorin University Hospital

    Mitaka, Tokyo, Japan

  • Nagasaki University Hospital

    Nagasaki, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, Japan

  • Nakamura Hospital

    Beppu, Oita Prefecture, Japan

  • Nanri Urological Clinic

    Saga, Saga-ken, Japan

  • Niimura Hospital

    Kagoshima, Kagoshima-ken, Japan

  • Okayama University Hospital

    Okayama, Okayama-ken, Japan

  • Rakuwakai Marutamachi Hospital

    Kyoto, Kyoto, Japan

  • Shinshu University Hospital

    Matsumoto, Nagano, Japan

  • The Jikei University Hospital

    Minato-Ku, Tokyo, Japan

  • The University Of Tokyo Hospital

    Tokyo, Tokyo, Japan

  • Toyama Rosai Hospital

    Uozu, Toyama, Japan

  • Ueda Clinic

    Kyoto, Kyoto, Japan

  • University Of Yamanashi Hospital

    Chūō, Yamanashi, Japan

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