Clinical trial NCT06752603: A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hunner Type Interstitial Cystitis
Keywords: ONO-1110
ONO-1110-06
Hunner Type Interstitial Cystitis
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in weekly mean of average pain score from baseline to Week 12 of the treatment period
timeFrame: Up to 20 weeks
measure: Adverse events
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Change in weekly mean of average pain score from baseline in each week
timeFrame: Up to 20 weeks
measure: 30%- and 50%-responder rates based on the weekly mean of average pain score
timeFrame: Up to 20 weeks
measure: Change in weekly mean of worst pain score from baseline to each week
timeFrame: Up to 20 weeks
measure: 30%- and 50%-responder rates based on the weekly mean of worst pain score
timeFrame: Up to 20 weeks
measure: Change in Interstitial cystitis symptom index (ICSI) score from baseline
timeFrame: Up to 20 weeks
measure: Change in Interstitial cystitis problem index (ICPI) score from baseline
timeFrame: Up to 20 weeks
measure: Change in Average frequency of urination per day from baseline
timeFrame: Up to 20 weeks
measure: Change in Frequency of nocturnal urination per day from baseline
timeFrame: Up to 20 weeks
measure: Change in Mean volume voided per micturition in a day from baseline
timeFrame: Up to 20 weeks
measure: Change in Maximum volume voided per micturition in a day from baseline
timeFrame: Up to 20 weeks
measure: Change in Number of urgency episodes per day from baseline
timeFrame: Up to 20 weeks
measure: Change in Patient Global Impression of Change (PGIC) score from baseline
timeFrame: Up to 20 weeks
measure: Change in SF-12v2 score from baseline
timeFrame: Up to 20 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
timeFrame: Up to 20 weeks
measure: Plasma ONO-1110 concentrations
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Takasaki
country: Japan
facility: Kurosawa Hospital Health Park Clinic
state: Gunma
city: Kawasaki
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Izumi Chuo Hospital
state: Miyagi
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Beppu
country: Japan
facility: Nakamura Hospital
state: Oita
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Uozu
country: Japan
facility: Toyama Rosai Hospital
state: Toyama
city: Chuo
country: Japan
facility: University Of Yamanashi Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Harasanshin Hospital
city: Gifu
country: Japan
facility: Japanese Red Cross Gifu Hospital
city: Kyoto
country: Japan
facility: Ueda Clinic
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Saga
country: Japan
facility: Nanri Urological Clinic
city: Tokyo
country: Japan
facility: The University Of Tokyo Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: