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

Phase 2Active Not RecruitingNCT06752603

Ono Pharmaceutical Co., Ltd.50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hunner Type Interstitial Cystitis

Interventions

ONO-1110DRUG

ONO-1110 tablets once a day

PlaceboDRUG

Placebo tablets once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Harasanshin Hospital

Fukuoka, Fukuoka, Japan

Outcomes

Primary Outcomes

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

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

proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively

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

proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively

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

Data from ClinicalTrials.gov

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