Hunner Type Interstitial Cystitis
Conditions
Sponsors
Terasawa Tetsuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese (both sexes) 2. Age (at the time of informed consent): 18 years and older 3. Outpatient 4. 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) 5. Patients given a diagnosis of HIC by cystoscopy 6. Patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria
Exclusion criteria
Exclusion criteria: 1. Patients with a history and presence of chemical cystitis 2. Patients with a history of bladder augmentation or radical cystectomy 3. Patients with pain other than HIC that may affect assessments in this study 4. Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study 5. Patients receiving medications for psychiatric disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Change in weekly mean of average pain score from baseline Safety: Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Pharmacokinetics | — |
Contacts
Public ContactSupport Desk JP
Ono Pharmaceutical Co.,LTD.
Outcome results
None listed