A Clinical Study of ONO-1110 in Patients With 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

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

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