ClinicalTrials.gg
Sign In
CompletedNCT01004315Updated Jul 27, 2010

A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

A Phase 3 interventional study of KUC-7483 and Placebo in Overactive Bladder, sponsored by Kissei Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-07-27.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Overactive Bladder

Keywords

  • Overactive bladder
  • Frequency
  • Micturition
  • Urgency
  • Urge urinary incontinence
  • OAB
03

In context

Urinary Bladder, Overactive

864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's planned enrollment of 750 is above the median of 70 across 660 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 63 studies on the registry; 3 are open to participants now.

Browse Kissei Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients who are diagnosed as stress urinary incontinence are predominant.
  • Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    KUC-7483

    Drug: KUC-7483

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    Tolterodine

    Drug: Tolterodine

Interventions

06

What researchers measure

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Japan
    Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01004315
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
First posted
Oct 29, 2009
Last update
Jul 27, 2010

Study contacts

Yasuhiro Omori
study director · Clinical Development Department, Kissei pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Ritobegron ethyl · Ritobegron

Other studies in this condition

Urinary Bladder, Overactive →

Other studies from this sponsor

Kissei Pharmaceutical Co., Ltd. →

Start the discussion