Clinical trial NCT03106623: Study of ONO-8577 in Patients With Overactive Bladder
Official title: Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 207
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to combination of solifenacin succinate and mirabegron or placebo for overactive bladder


Eligibility criteria: Inclusion Criteria:

* Patient with symptoms of overactive bladder for ≥6 months

Exclusion Criteria:

* Patient with genuine stress incontinence, or with stress-predominant mixed urinary incontinence
* Patient who has never experienced urge urinary incontinence during disease duration of overactive bladder

Primary outcomes:
measure: Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)
timeFrame: Up to Week 4
measure: Pharmacokinetics (plasma concentration at one point on each visit)
timeFrame: Week 2 and 4
measure: Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)
timeFrame: Baseline and Week 2
measure: Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)
timeFrame: Baseline, Week 2 and 4
measure: Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours)
timeFrame: Baseline, Week 2 and 4
measure: Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours)
timeFrame: Baseline, Week 2 and 4
measure: Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours)
timeFrame: Baseline, Week 2 and 4
measure: Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours)
timeFrame: Baseline, Week 2 and 4
measure: Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)
timeFrame: Week 2 and 4
measure: Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4
timeFrame: Week 2 and 4
measure: Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition)
timeFrame: Baseline, Week 2 and 4
measure: Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )
timeFrame: Baseline, Week 2 and 4
measure: Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)
timeFrame: Baseline and Week 4
measure: Efficacy (Patient Global Impression at Week 4)
timeFrame: Week 4
Other outcomes:
Locations:
city: Maebashi
country: Japan
facility: Gunma Clinical Site 02
state: Gunma
city: Takasaki
country: Japan
facility: Gunma Clinical Site 01
state: Gunma
city: Akashi
country: Japan
facility: Hyogo Clinical Site 02
state: Hyogo
city: Kobe
country: Japan
facility: Hyogo Clinical Site 01
state: Hyogo
city: Kobe
country: Japan
facility: Hyogo Clinical Site 03
state: Hyogo
city: Takarazuka
country: Japan
facility: Hyogo Clinical Site 04
state: Hyogo
city: Isehara
country: Japan
facility: Kanagawa Clinical Site 01
state: Kanagawa
city: Kamakura
country: Japan
facility: Kanagawa Clinical Site 02
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kanagawa Clinical Site 03
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site 04
state: Kanagawa
city: Higashiosaka
country: Japan
facility: Osaka Clinical Site 03
state: Osaka
city: Ibaraki
country: Japan
facility: Osaka Clinical Site 04
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Clinical Site 02
state: Osaka
city: Suita
country: Japan
facility: Osaka Clinical Site 05
state: Osaka
city: Toyonaka
country: Japan
facility: Osaka Clinical Site 06
state: Osaka
city: Toyonaka
country: Japan
facility: Osaka Clinical Site 07
state: Osaka
city: Kumagaya
country: Japan
facility: Saitama Clinical Site 01
state: Saitama
city: Osaka
country: Japan
facility: Osaka Clinical Site 01
state: Takatsuki-shi
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site 10
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Tokyo Clinical Site 01
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Tokyo Clinical Site 06
state: Tokyo
city: Nakano-ku
country: Japan
facility: Tokyo Clinical Site 09
state: Tokyo
city: Nerima-ku
country: Japan
facility: Tokyo Clinical Site 07
state: Tokyo
city: Ota-ku
country: Japan
facility: Tokyo Clinical Site 03
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Tokyo Clinical Site 08
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Tokyo Clinical Site 11
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Clinical Site 04
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Clinical Site 05
state: Tokyo
city: Suginami-ku
country: Japan
facility: Tokyo Clinical Site 02
state: Tokyo
city: Kyoto
country: Japan
facility: Kyoto Clinical Site 01
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Hitoshi Kajitani
role: STUDY_DIRECTOR
References: