Evaluating ONO-1110 for treating Hunner Type Interstitial Cystitis

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

This study is testing a new treatment called ONO-1110 to see if it can help adults in Japan with Hunner Type Interstitial Cystitis feel less pain and improve their urinary symptoms.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ono Pharmaceutical Co. Ltd (industry)
• Locations: 15 sites (Nagoya, Aichi and 14 other locations)
• Trial ID: NCT06752603 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of ONO-1110 in patients diagnosed with Hunner Type Interstitial Cystitis (HIC). Participants will be randomly assigned to receive either ONO-1110 or a placebo, with their responses monitored through pain diaries, bladder diaries, and questionnaires. The study focuses on Japanese adults aged 18 and older who experience chronic pelvic pain and urinary symptoms associated with HIC. The trial will be conducted at multiple locations in Japan, ensuring a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are Japanese adults aged 18 and older with a confirmed diagnosis of Hunner Type Interstitial Cystitis and chronic pelvic pain.

Not a fit: Patients with chemical cystitis, bladder augmentation, or other conditions affecting bladder assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms and improve the quality of life for patients suffering from Hunner Type Interstitial Cystitis.

How similar studies have performed: While this approach is focused on a specific treatment for HIC, similar studies have shown promise in addressing chronic pelvic pain conditions.

Eligibility criteria

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

Where this trial is running

Nagoya, Aichi and 14 other locations

• Nagoya University Hospital — Nagoya, Aichi, Japan (RECRUITING)
• Kurosawa Hospital Health Park Clinic — Takasaki, Gunma, Japan (RECRUITING)
• Kanto Rosai Hospital — Kawasaki, Kanagawa, Japan (RECRUITING)
• Izumi Chuo Hospital — Sendai, Miyagi, Japan (RECRUITING)
• Shinshu University Hospital — Matsumoto, Nagano, Japan (RECRUITING)
• Nakamura Hospital — Beppu, Oita, Japan (RECRUITING)
• The Jikei University Hospital — Minato-Ku, Tokyo, Japan (NOT_YET_RECRUITING)
• Toyama Rosai Hospital — Uozu, Toyama, Japan (RECRUITING)
• University Of Yamanashi Hospital — Chuo, Yamanashi, Japan (RECRUITING)
• Harasanshin Hospital — Fukuoka, Japan (RECRUITING)
• Japanese Red Cross Gifu Hospital — Gifu, Japan (RECRUITING)
• Ueda Clinic — Kyoto, Japan (RECRUITING)
• Okayama University Hospital — Okayama, Japan (RECRUITING)
• Nanri Urological Clinic — Saga, Japan (RECRUITING)
• The University Of Tokyo Hospital — Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: Ono Pharmaceutical Co., Ltd

Conditions: Hunner Type Interstitial Cystitis, ONO-1110, ONO-1110-06