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

NCT00189800 | Completed Phase 3

• 1 other identifier: 90502/KOoTD01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

Conditions

Overactive Bladder

Keywords

Solifenacin; tolterodine; randomized controlled trial; double-blind method

Interventions

Solifenacin succinate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (10)

Unknown Facility

Anyang, South Korea

Location

Unknown Facility

Bucheon-si, South Korea

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Cheonan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

Related Publications (3)

• 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

  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.

  PMID: 37160401 DERIVED

• 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.

  PMID: 19143854 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Prof. Jeong Gu Lee

  Department of Urology, Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Last Updated: November 17, 2011

Record last verified: 2006-10

Locations

KR (10)