NCT00368706

Brief Summary

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

August 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

Enrollment Period

1.5 years

First QC Date

August 24, 2006

Last Update Submit

April 9, 2008

Conditions

Urinary Bladder, Overactive

Keywords

solifenacinOveractive bladderUrinary incontinenceTreatment outcomesVESIcare

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean number of micturitions per 24 hours

    8 Weeks

Secondary Outcomes (4)

  • Change from baseline in mean volume voided per micturition

    8 Weeks

  • Change from baseline in mean number of incontinence episodes per 24 hours

    8 Weeks

  • Change from baseline in mean urgency frequency per 24 hours

    8 Weeks

  • Change from baseline in mean nocturia episodes per 24 hours

    8 Weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: solifenacin succinate

2

ACTIVE COMPARATOR
Drug: tolterodine

Interventions

solifenacin succinateDRUG

Oral

Also known as: Vesicare, YM905
1
tolterodineDRUG

oral

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients willing and able to complete the micturition diary correctly
  • Patients experiencing frequency of micturition as verified in the diary
  • Patients experiencing significant post void residual volume
  • OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

You may not qualify if:

  • Significant post void residual volume
  • Patients with indwelling catheters or practicing intermittent self- catheterization
  • Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Beijing, 100000, China

Location

Unknown Facility

Chongqing, 404000, China

Location

Unknown Facility

Hangzhou, 310000, China

Location

Unknown Facility

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Interventions

Solifenacin SuccinateTolterodine Tartrate

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 SymptomsUrination Disorders

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • Use Central Contact

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 25, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

CN(4)