A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

NCT ID: NCT00189800

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Solifenacin succinate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptoms of overactive bladder
* Must be able to complete the micturition diary

Exclusion Criteria

* Pregnant or lactating
* Clinically significant outflow obstruction
* Significant post void residual urine
* Significant stress incontinence
* Urinary tract infection
* Chronic inflammation
* Bladder stones
* Previous pelvic radiation therapy
* Previous or current malignant disease of the pelvic organs
* Uncontrolled narrow angle glaucoma
* Urinary or gastric retention
* Electrostimulation therapy
* Bladder training
* Diabetic neuropathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role collaborator

Principal Investigators

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Prof. Jeong Gu Lee

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Korea University Anam Hospital

Locations

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Anyang, , South Korea

Site Status

Bucheon-si, , South Korea

Site Status

Busan, , South Korea

Site Status

Cheonan, , South Korea

Site Status

Daegu, , South Korea

Site Status

Daejeon, , South Korea

Site Status

Gwangju, , South Korea

Site Status

Incheon, , South Korea

Site Status

Seoul, , South Korea

Site Status

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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EU Shi-liang, et al. Efficacy and safety of solifenacin in the treatment of patients with urgency and urge incontinence. Chin J Urol (2009) 30(9); 1-5

Reference Type BACKGROUND

Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Reference Type DERIVED
PMID: 37160401 (View on PubMed)

Choo MS, Lee JZ, Lee JB, Kim YH, Jung HC, Lee KS, Kim JC, Seo JT, Paick JS, Kim HJ, Na YG, Lee JG. Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study. Int J Clin Pract. 2008 Nov;62(11):1675-83. doi: 10.1111/j.1742-1241.2008.01898.x.

Reference Type DERIVED
PMID: 19143854 (View on PubMed)

Other Identifiers

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90502/KOoTD01

Identifier Type: -

Identifier Source: org_study_id