Open-Label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00463541

Purpose

To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: solifenacin succinate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial

Resource links provided by NLM:

Drug Information available for: Succinic acid Solifenacin Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients satisfied with 5mg treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Percentage of patients obtaining additional benefit with increase to 10mg dose [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Enrollment:	2225
Study Start Date:	June 2004
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: solifenacin succinate oral

Detailed Description:

Study included a 24 week extension that did not occur due to FDA approval of the product.

Eligibility

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

Criteria

Inclusion Criteria:

Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.

Exclusion Criteria:

-Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
Clinically significant outflow obstruction (benign prostatic hyperplasia)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463541

Show 198 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sand PK, Steers WD, Dmochowski R, Andoh M, Forero-Schwanhaeuser S. Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):667-75. Epub 2009 Mar 10.

Responsible Party:	Astellas Pharma US, Inc. ( Sr. Manager, Clinical Trials Registry )
Study ID Numbers:	905-UC-007
Study First Received:	April 19, 2007
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00463541 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Urinary Bladder, Overactive
Urgency
VESIcare®
Solifenacin succinate

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate

ClinicalTrials.gov processed this record on February 04, 2010