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NCT03106623 Clinical Trial

Study of ONO-8577 in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03106623
Other study ID # ONO-8577-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 7, 2017
Est. completion date September 26, 2017

Study information
Verified date May 2024
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 207
Est. completion date September 26, 2017
Est. primary completion date August 29, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-8577
Oral administration of ONO-8577 once a daily for 4 weeks
• solifenacin succinate + mirabegron
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
• Placebo
Oral administration of Placebo once a daily for 4 weeks

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

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours) Baseline and Week 4
Secondary Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test) Up to Week 4
Secondary Pharmacokinetics (plasma concentration at one point on each visit) Week 2 and 4
Secondary Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours) Baseline and Week 2
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Efficacy (Percentage of Participants With ?8 times of Micturitions Per 24 Hours at Week 2 and 4) Week 2 and 4
Secondary Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4 Week 2 and 4
Secondary Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition) Baseline, Week 2 and 4
Secondary Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) ) Baseline, Week 2 and 4
Secondary Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life) Baseline and Week 4
Secondary Efficacy (Patient Global Impression at Week 4) Week 4
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Completed NCT02667470 - Reproducibility Study of OABSS and Its Response to Treatment Phase 4