Status:

COMPLETED

SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)

Lead Sponsor:

Sumitomo Pharma America, Inc.

Collaborating Sponsors:

Dainippon Sumitomo Pharma America

ICON Clinical Research

Conditions:

Overactive Bladder Syndrome (OABS)

Eligibility:

All Genders

20-80 years

Phase:

PHASE2

Brief Summary

SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg...

Detailed Description

A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment period with pati...

Eligibility Criteria

Inclusion

  • Main
  • Males, or females who are not of child-bearing potential
  • Aged 20-80 years (inclusive) with a diagnosis of OABS based on symptomatic reporting over a period of 6 months (micturition frequency, and urgency with or without incontinence) prior to screening.

Exclusion

  • Main

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

550 Patients enrolled

Trial Details

Trial ID

NCT00409539

Start Date

December 1 2006

End Date

July 1 2008

Last Update

December 10 2014

Active Locations (69)

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Page 1 of 18 (69 locations)

1

Visions Clinical Research

Tuscon, Arizona, United States, 85712

2

Peninsula Urology Center

Atherton, California, United States, 94027

3

San Bernadino Urological Association Medical Group

San Bernadino, California, United States, 92404

4

9040 Friars Road

San Diego, California, United States, 92108