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Clinical study of Solifenacin and Imidafenacin in OAB patients with nocturia

Clinical study of Solifenacin and Imidafenacin in OAB patients with nocturia - Blue-Note study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009137
Enrollment
80
Registered
2012-10-18
Start date
2012-10-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder

Interventions

Imidafenacin 0.1mg will be orally administered twice a day, once after breakfast and dinner for 12 weeks. Solifenacin 5mg will be orally administered once after breakfast for 12 weeks.

Sponsors

Clinical Research Support Center Kyushu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) OAB patients (urgency score (OABSS) >= 2 and nighttime frequency score >= 2) 2) 20 years old or more patients 3) Patients from whom we have received written consent.

Exclusion criteria

Exclusion criteria: 1) Patients who have administered prohibited substances or done prohibited therapy within the 4weeks before enrollment 2) Patients who started restricted substances and changed usage or dosage of restricted substances for determined period before enrollment 3) Patients with prostate cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, urinary tract infection, urinary tract stones and interstitial cystitis 4) Patients with urinary retention 5) Patients with obstruction of pylorus, duodenum and gut and patients with paralytic ileus 6) Patients with decrease of enterokinesis and gastrointestinal tract tension 7) Patients with closure-angle glaucoma 8) Patients with myasthenia gravis 9) Patients with serious liver dysfunction, kidney dysfunction and heart disease. 10) Hypersensitivity to anti-cholinergic agents. 11) Residual urine volume is more than 100mL 12) Patients with polyuria 13) Any other patients who are regarded as unsuitable for this study by the investigator

Design outcomes

Primary

MeasureTime frame
Usefulness for nocturia

Countries

Japan

Contacts

Public ContactSadaaki Sakamoto

Nakamura Hospital Urology

info4@cres-kyushu.or.jp0977-23-3121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026