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

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Hunner Type Interstitial Cystitis

Treatments: Drug: ONO-1110; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06752603

ONO-1110-06

jRCT2031240558 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

ONO-1110

Experimental group

Description:

ONO-1110 tablets once a day

Treatment:

Drug: ONO-1110

Placebo

Placebo Comparator group

Description:

Placebo tablets once daily

Treatment:

Drug: Placebo