NCT01003405

Brief Summary

To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

First QC Date

October 27, 2009

Last Update Submit

July 25, 2010

Conditions

Overactive Bladder

Keywords

Overactive bladderFrequencyMicturitionUrgencyUrge urinary incontinenceOAB

Outcome Measures

Primary Outcomes (1)

  • The long-term safety of KUC-7483 for the treatment of overactive bladder.

    52 weeks

Secondary Outcomes (1)

  • The long-term efficacy of KUC-7483 for the treatment of overactive bladder.

    52 weeks

Study Arms (1)

KUC-7483

EXPERIMENTAL
Drug: KUC-7483

Interventions

KUC-7483DRUG
KUC-7483

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have successfully completed the Phase III double-blind study.

You may not qualify if:

  • Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu, Japan

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Interventions

ritobegron ethyl

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Yasuhiro Omori

    Clinical Development Department, Kissei pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

JP(1)