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

NCT06752603 | Active Not Recruiting Phase 2

• 2 other identifiers: ONO-1110-06jRCT2031240558
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Hunner Type Interstitial Cystitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in weekly mean of average pain score from baseline to Week 12 of the treatment period

  Up to 20 weeks

• Adverse events

  Up to 20 weeks

Secondary Outcomes (15)

• 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

• 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

• Change in Interstitial cystitis symptom index (ICSI) score from baseline

  Up to 20 weeks

Study Arms (2)

ONO-1110

EXPERIMENTAL

ONO-1110 tablets once a day

Drug: ONO-1110

Placebo

PLACEBO COMPARATOR

Placebo tablets once daily

Drug: Placebo

Interventions

Placebo DRUG

Placebo tablets once daily

Placebo

ONO-1110 DRUG

ONO-1110 tablets once a day

ONO-1110

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (20)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

Harasanshin Hospital

Fukuoka, Fukuoka, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Location

Japanese Red Cross Gifu Hospital

Gifu, Gifu, Japan

Location

Kurosawa Hospital Health Park Clinic

Takasaki, Gunma, Japan

Location

Niimura Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan

Location

Rakuwakai Marutamachi Hospital

Kyoto, Kyoto, Japan

Location

Ueda Clinic

Kyoto, Kyoto, Japan

Location

Izumi Chuo Hospital

Sendai, Miyagi, Japan

Location

Shinshu University Hospital

Matsumoto, Nagano, Japan

Location

Nakamura Hospital

Beppu, Oita Prefecture, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, Japan

Location

Nanri Urological Clinic

Saga, Saga-ken, Japan

Location

The Jikei University Hospital

Minato-Ku, Tokyo, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, Japan

Location

The University Of Tokyo Hospital

Tokyo, Tokyo, Japan

Location

Toyama Rosai Hospital

Uozu, Toyama, Japan

Location

University Of Yamanashi Hospital

Chūō, Yamanashi, Japan

Location

Nagasaki University Hospital

Nagasaki, Japan

Location

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: April 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (20)