NCT00742833

Brief Summary

To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

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

August 5, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

First QC Date

August 5, 2008

Last Update Submit

September 2, 2009

Conditions

Overactive Bladder (OAB)

Keywords

Overactive bladderFrequencyMicturitionUrgencyUrge urinary incontinenceβ3-agonist

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean number of micturitions per 24 hours

    12 weeks

Secondary Outcomes (2)

  • Change from baseline in mean number of urgency episodes per 24 hours

    12 weeks

  • Change from baseline in mean number of incontinence episodes per 24 hours

    12 weeks

Study Arms (2)

3

EXPERIMENTAL
Drug: KUC-7483

1

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KUC-7483DRUG
3
PlaceboDRUG
1

Eligibility Criteria

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

You may qualify if:

  • Patients with a symptom of overactive bladder for more than 6 months.
  • Patients who meet the following condition during the 3-day bladder diary period.
  • the mean number of micturitions per 24 hours is ≥8 times
  • the mean number of urgency episodes per 24 hours is ≥1 time

You may not qualify if:

  • Patients who are diagnosed as stress urinary incontinence are predominant.
  • Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Japan

Hokkaido Region, Japan

Location

Japan

Kansai Region, Japan

Location

Japan

Kanto Region, Japan

Location

Japan

Kyushu Region, Japan

Location

Japan

Shikoku Region, Japan

Location

Japan

Tohoku Region, 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

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 28, 2008

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

JP(6)