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A Randomized, Double-Blind, Parallel-Group Study of SMP-986 in Patients with Overactive Bladder [Phase 2 Study]

A Randomized, Double-Blind, Parallel-Group Study of SMP-986 in Patients with Overactive Bladder [Phase 2 Study]

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221224
Enrollment
320
Registered
2010-09-01
Start date
2010-09-01
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

investigational material(s) Generic name etc : SMP-986 INN of investigational material : Therapeutic category code : 251 Agents affecting urinary organs Dosage and Administration for Investigational

Sponsors

Dainippon Sumitomo Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient with overactive bladder who meets the following criteria -Outpatient -Patient has overactive bladder syndrome over a successive period of at least 6 months prior to onset of the study -Patient can get to a bathroom without assistance and can record the bladder diary accurately

Exclusion criteria

Exclusion criteria: -Patient with bladder outlet obstruction -Patient has a neurological disease which has potential to cause overactive bladder syndrome -Patient has a polyuria

Design outcomes

Primary

MeasureTime frame
Efficacy: Change from baseline in number of voids per day At 12 weeks

Secondary

MeasureTime frame
Efficacy: Change from baseline in number of urgency episodes per day At 12 weeks

Outcome results

None listed

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