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

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ClinicalTrials.gov Identifier: NCT00189800
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 17, 2011
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder Drug: Solifenacin succinate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189800


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

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

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ClinicalTrials.gov Identifier: NCT00189800     History of Changes
Other Study ID Numbers: 90502/KOoTD01
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: October 2006

Keywords provided by Astellas Pharma Inc:
Solifenacin
tolterodine
randomized controlled trial
double-blind method

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Tolterodine Tartrate
 Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents