NCT01004315

Brief Summary

To evaluate the efficacy and the 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
750

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

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

October 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 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)

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

    12 weeks

Secondary Outcomes (2)

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

    12 weeks

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

    12 weeks

Study Arms (3)

KUC-7483

EXPERIMENTAL
Drug: KUC-7483

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Tolterodine

ACTIVE COMPARATOR
Drug: Tolterodine

Interventions

KUC-7483DRUG
KUC-7483
PlaceboDRUG
Placebo
TolterodineDRUG
Tolterodine

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 (1)

Japan

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

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Interventions

ritobegron ethylTolterodine Tartrate

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

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • Yasuhiro Omori

    Clinical Development Department, Kissei pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 29, 2009

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

JP(1)