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

Phase 2

Recruiting

• Conditions: Hunner Type Interstitial Cystitis
• Interventions: Drug: ONO-1110; Drug: Placebo

• Registration Number: NCT06752603
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Study First Posted: 2024-12-30
• Status Verified: 2025-04
• Study Start: 2025-04-02
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-06
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-1110	ONO-1110	ONO-1110 tablets once a day
Placebo	Placebo	Placebo tablets once daily

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 20 weeks
Change in weekly mean of average pain score from baseline to Week 12 of the treatment period	Up to 20 weeks

Secondary Outcome Measures

Name	Time	Method
Change in weekly mean of average pain score from baseline in each week	Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score	Up to 20 weeks	proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively
Change in weekly mean of worst pain score from baseline to each week	Up to 20 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score	Up to 20 weeks	proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively
Change in Interstitial cystitis symptom index (ICSI) score from baseline	Up to 20 weeks
Change in Interstitial cystitis problem index (ICPI) score from baseline	Up to 20 weeks
Change in Average frequency of urination per day from baseline	Up to 20 weeks
Change in Frequency of nocturnal urination per day from baseline	Up to 20 weeks
Change in Mean volume voided per micturition in a day from baseline	Up to 20 weeks
Change in Maximum volume voided per micturition in a day from baseline	Up to 20 weeks
Change in Number of urgency episodes per day from baseline	Up to 20 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline	Up to 20 weeks
Change in SF-12v2 score from baseline	Up to 20 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline	Up to 20 weeks
Plasma ONO-1110 concentrations	Up to 20 weeks

Trial Locations

Locations (15)

Harasanshin Hospital; 🇯🇵 Fukuoka, Japan

Japanese Red Cross Gifu Hospital; 🇯🇵 Gifu, Japan

Ueda Clinic; 🇯🇵 Kyoto, Japan

Nakamura Hospital; 🇯🇵 Beppu, Oita, Japan

Toyama Rosai Hospital; 🇯🇵 Uozu, Toyama, Japan

Izumi Chuo Hospital; 🇯🇵 Sendai, Miyagi, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Shinshu University Hospital; 🇯🇵 Matsumoto, Nagano, Japan

The Jikei University Hospital; 🇯🇵 Minato-Ku, Tokyo, Japan

University Of Yamanashi Hospital; 🇯🇵 Chuo, Yamanashi, Japan

Kurosawa Hospital Health Park Clinic; 🇯🇵 Takasaki, Gunma, Japan

Kanto Rosai Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan

Okayama University Hospital; 🇯🇵 Okayama, Japan

Nanri Urological Clinic; 🇯🇵 Saga, Japan

The University Of Tokyo Hospital; 🇯🇵 Tokyo, Japan