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

This study has been completed.

Sponsor:

Collaborator:

Astellas Pharma Korea, Inc.

Information provided by:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00189800

First received: September 13, 2005

Last updated: November 15, 2011

Last verified: October 2006

History of Changes

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: Solifenacin succinate	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Overactive Bladder

Drug Information available for: Succinic acid Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189800

Locations


Korea, Republic of

Anyang, Korea, Republic of

Bucheon, Korea, Republic of

Busan, Korea, Republic of

Cheonan, Korea, Republic of

Daegu, Korea, Republic of

Daejeon, Korea, Republic of

Gwangju, Korea, Republic of

Incheon, Korea, Republic of

Seoul, Korea, Republic of

Suwon, Korea, Republic of

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Investigators


Principal Investigator:	Prof. Jeong Gu Lee	Department of Urology, Korea University Anam Hospital

More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00189800 History of Changes
Other Study ID Numbers:	90502/KOoTD01
Study First Received:	September 13, 2005
Last Updated:	November 15, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:


Solifenacin tolterodine randomized controlled trial double-blind method

Additional relevant MeSH terms:


Urinary Bladder, Overactive Lower Urinary Tract Symptoms Signs and Symptoms Urinary Bladder Diseases Urologic Diseases Urological Manifestations Solifenacin Cholinergic Agents	Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Muscarinic Antagonists Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Urological Agents

ClinicalTrials.gov processed this record on March 03, 2015

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