NCT00431041

Brief Summary

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 11, 2010

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

1.2 years

First QC Date

February 1, 2007

Results QC Date

October 5, 2009

Last Update Submit

June 1, 2010

Conditions

Overactive Bladder

Keywords

Solifenacin succinateOxybutynin immediate releaseXerostomiaOveractive bladder

Outcome Measures

Primary Outcomes (2)

  • The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event

    The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit

    8 weeks

  • The Severity of Dry Mouth Reported as an Adverse Event

    The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE). Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) \& "severe" (very dry mouth \& throat, difficulty swallowing solid food without water)

    8 weeks

Secondary Outcomes (2)

  • Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary

    Baseline and 8 Weeks

  • Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary

    Baseline and 8 weeks

Study Arms (2)

Solifenacin

EXPERIMENTAL

Solifenacin succinate: 5 mg tablets, taken orally, once daily

Drug: solifenacin

Oxybutynin IR

ACTIVE COMPARATOR

Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day

Drug: oxybutynin immediate release

Interventions

solifenacinDRUG

Oral

Also known as: VESIcare®, YM905
Solifenacin
oxybutynin immediate releaseDRUG

Oral

Oxybutynin IR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years and older.
  • Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: \> 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

You may not qualify if:

  • Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
  • Clinically significant outflow obstruction
  • Uncontrolled narrow angle glaucoma, urinary, or gastric retention
  • Severe renal or hepatic impairment
  • Chronic severe constipation or history of diagnosed GI obstructive disease
  • Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • Diagnosis or history of neurogenic bladder
  • History of bladder or pelvic cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Calgary, Alberta, T2V 4R6, Canada

Location

Unknown Facility

Edmonton, Alberta, T5H 3V9, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6T 2B5, Canada

Location

Unknown Facility

Victoria, British Columbia, V8T 5G1, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Unknown Facility

Guelph, Ontario, N1H 5J1, Canada

Location

Unknown Facility

Kitchener, Ontario, N2N 2B9, Canada

Location

Unknown Facility

Toronto, Ontario, M4N 3M5, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 1Z5, Canada

Location

Unknown Facility

Toronto, Ontario, M5T 2S8, Canada

Location

Unknown Facility

Toronto, Ontario, M6A 3B5, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (3)

  • Herschorn S, Stothers L, Carlson K, Egerdie B, Gajewski JB, Pommerville P, Schulz J, Radomski S, Drutz H, Barkin J, Paradiso-Hardy F. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. J Urol. 2010 May;183(5):1892-8. doi: 10.1016/j.juro.2010.01.012. Epub 2010 Mar 29.

    PMID: 20303119BACKGROUND

  • Herschorn S, Pommerville P, Stothers L, Egerdie B, Gajewski J, Carlson K, Radomski S, Drutz H, Schulz J, Barkin J, Hirshberg E, Corcos J. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. Curr Med Res Opin. 2011 Feb;27(2):375-82. doi: 10.1185/03007995.2010.541433. Epub 2010 Dec 23.

    PMID: 21175373DERIVED

  • Herschorn S, Vicente C, Piwko C. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder. J Med Econ. 2010;13(3):508-15. doi: 10.3111/13696998.2010.509244.

    PMID: 20690893DERIVED

Related Links

MeSH Terms

Conditions

Urinary Bladder, OveractiveXerostomia

Interventions

Solifenacin Succinateoxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The relatively high incidence of AEs, specifically dry mouth, in both groups may be a result of the direct questioning methodology used. Subjects were also informed the primary objectives were the relative frequency and severity of dry mouth.

Results Point of Contact

Title
Astellas Medical Monitor
Organization
Astellas Pharma Global Development
ClinicalTrials@us.astellas.com

Study Officials

  • Use Central Contact

    Astellas Pharma Canada, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

December 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

June 8, 2010

Results First Posted

January 11, 2010

Record last verified: 2010-06

Locations

CA(12)