Study of ONO-8577 in Patients With Overactive Bladder

Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: ONO-8577; Drug: solifenacin succinate + mirabegron; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan
    • Kyoto Clinical Site 01
  • Gunma
    • Maebashi, Gunma, Japan
      • Gunma Clinical Site 02
    • Takasaki, Gunma, Japan
      • Gunma Clinical Site 01
  • Hyogo
    • Akashi, Hyogo, Japan
      • Hyogo Clinical Site 02
    • Kobe, Hyogo, Japan
      • Hyogo Clinical Site 01
    • Kobe, Hyogo, Japan
      • Hyogo Clinical Site 03
    • Takarazuka, Hyogo, Japan
      • Hyogo Clinical Site 04
  • Kanagawa
    • Isehara, Kanagawa, Japan
      • Kanagawa Clinical Site 01
    • Kamakura, Kanagawa, Japan
      • Kanagawa Clinical Site 02
    • Sagamihara, Kanagawa, Japan
      • Kanagawa Clinical Site 03
    • Yokohama, Kanagawa, Japan
      • Kanagawa Clinical Site 04
  • Osaka
    • Higashiosaka, Osaka, Japan
      • Osaka Clinical Site 03
    • Ibaraki, Osaka, Japan
      • Osaka Clinical Site 04
    • Osaka-shi, Osaka, Japan
      • Osaka Clinical Site 02
    • Suita, Osaka, Japan
      • Osaka Clinical Site 05
    • Toyonaka, Osaka, Japan
      • Osaka Clinical Site 06
    • Toyonaka, Osaka, Japan
      • Osaka Clinical Site 07
  • Saitama
    • Kumagaya, Saitama, Japan
      • Saitama Clinical Site 01
  • Takatsuki-shi
    • Osaka, Takatsuki-shi, Japan
      • Osaka Clinical Site 01
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
      • Tokyo Clinical Site 10
    • Edogawa-ku, Tokyo, Japan
      • Tokyo Clinical Site 01
    • Itabashi-ku, Tokyo, Japan
      • Tokyo Clinical Site 06
    • Nakano-ku, Tokyo, Japan
      • Tokyo Clinical Site 09
    • Nerima-ku, Tokyo, Japan
      • Tokyo Clinical Site 07
    • Ota-ku, Tokyo, Japan
      • Tokyo Clinical Site 03
    • Setagaya-ku, Tokyo, Japan
      • Tokyo Clinical Site 08
    • Setagaya-ku, Tokyo, Japan
      • Tokyo Clinical Site 11
    • Shinagawa-ku, Tokyo, Japan
      • Tokyo Clinical Site 04
    • Shinagawa-ku, Tokyo, Japan
      • Tokyo Clinical Site 05
    • Suginami-ku, Tokyo, Japan
      • Tokyo Clinical Site 02

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ONO-8577 Arm; Oral administration of ONO-8577 once a daily for 4 weeks	Drug: ONO-8577; Oral administration of ONO-8577 once a daily for 4 weeks
ACTIVE_COMPARATOR: Active Comparator Arm; Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks	Drug: solifenacin succinate + mirabegron; Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
PLACEBO_COMPARATOR: Placebo Arm; Oral administration of Placebo once a daily for 4 weeks	Drug: Placebo; Oral administration of Placebo once a daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)	Up to Week 4
Pharmacokinetics (plasma concentration at one point on each visit)	Week 2 and 4
Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)	Baseline and Week 2
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)	Week 2 and 4
Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4	Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition)	Baseline, Week 2 and 4
Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )	Baseline, Week 2 and 4
Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)	Baseline and Week 4
Efficacy (Patient Global Impression at Week 4)	Week 4

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Hitoshi Kajitani, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 7, 2017
• Primary Completion (ACTUAL): August 29, 2017
• Study Completion (ACTUAL): September 26, 2017

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron; Solifenacin Succinate
• Other Study ID Numbers: ONO-8577-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No