Hunner Type Interstitial Cystitis
Conditions
Keywords
ONO-1110, ONO-1110-06, Hunner Type Interstitial Cystitis
Brief summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis
Interventions
DRUGONO-1110
ONO-1110 tablets once a day
DRUGPlacebo
Placebo tablets once daily
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively |
| 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 | proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively |
| Change in Interstitial cystitis symptom index (ICSI) score from baseline | Up to 20 weeks | — |
| Change in Interstitial cystitis problem index (ICPI) score from baseline | Up to 20 weeks | — |
| Change in Average frequency of urination per day from baseline | Up to 20 weeks | — |
| Change in Frequency of nocturnal urination per day from baseline | Up to 20 weeks | — |
| Change in Mean volume voided per micturition in a day from baseline | Up to 20 weeks | — |
| Change in Maximum volume voided per micturition in a day from baseline | Up to 20 weeks | — |
| Change in Number of urgency episodes per day from baseline | Up to 20 weeks | — |
| Change in Patient Global Impression of Change (PGIC) score from baseline | Up to 20 weeks | — |
| Change in SF-12v2 score from baseline | Up to 20 weeks | — |
| Change in Hospital Anxiety and Depression Scale (HADS) score from baseline | Up to 20 weeks | — |
| Plasma ONO-1110 concentrations | Up to 20 weeks | — |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed