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Completed

NCT Number: NCT03106623

Study of ONO-8577 in Patients With 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

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gunma Clinical Site 02, Maebashi, Gunma, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-8577

Drug

Oral administration of ONO-8577 once a daily for 4 weeks

solifenacin succinate + mirabegron

Drug

Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks

Placebo

Drug

Oral administration of Placebo once a daily for 4 weeks

Primary outcomes

  1. Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)

    Time frame: Baseline and Week 4

Secondary outcomes

  1. Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)

    Time frame: Up to Week 4

  2. Pharmacokinetics (plasma concentration at one point on each visit)

    Time frame: Week 2 and 4

  3. Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)

    Time frame: Baseline and Week 2

  4. Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)

    Time frame: Baseline, Week 2 and 4

  5. Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours)

    Time frame: Baseline, Week 2 and 4

  6. Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours)

    Time frame: Baseline, Week 2 and 4

  7. Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours)

    Time frame: Baseline, Week 2 and 4

  8. Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours)

    Time frame: Baseline, Week 2 and 4

  9. Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)

    Time frame: Week 2 and 4

  10. Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4

    Time frame: Week 2 and 4

  11. Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition)

    Time frame: Baseline, Week 2 and 4

  12. Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )

    Time frame: Baseline, Week 2 and 4

  13. Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)

    Time frame: Baseline and Week 4

  14. Efficacy (Patient Global Impression at Week 4)

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2017
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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