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NCT00463541 Clinical Trial

Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

Urinary Bladder, Overactive Clinical Trial

— VOLT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00463541
Other study ID # 905-UC-007
Secondary ID
Status Completed
Phase Phase 3
First received April 19, 2007
Last updated September 17, 2014
Start date June 2004
Est. completion date April 2005

Study information
Verified date September 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 2225
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• solifenacin succinate
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (5)

Capo' JP Jr, Laramée C, Lucente V, Fakhoury A, Forero-Schwanhaeuser S. Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare Open-Label Trial. Int J Clin Pract. 2008 Jan;62(1):39-46. Epub 2007 Nov 23. — View Citation

Garely AD, Kaufman JM, Sand PK, Smith N, Andoh M. Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006 Nov;28(11):1935-46. — View Citation

Garely AD, Lucente V, Vapnek J, Smith N. Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes. Ann Pharmacother. 2007 Mar;41(3):391-8. Epub 2007 Mar 6. — View Citation

Mallett V, Burks D, Garely AD, Smith N. Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes. Curr Med Res Opin. 2007 Apr;23(4):821-31. — View Citation

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. doi: 10.1007/s00192-009-0840-y. Epub 2009 Mar 10. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms Weeks 4, 8 and 12 No
Secondary Percentage of patients satisfied with 5mg treatment Week 12 No
Secondary Percentage of patients obtaining additional benefit with increase to 10mg dose week 12 No
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