NCT00699049

Brief Summary

The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

3 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

June 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

June 16, 2008

Last Update Submit

January 6, 2016

Conditions

Urinary Bladder, Overactive

Keywords

Alpha blockerTamsulosinSolifenacinOveractive BladderUrgency incontinence

Outcome Measures

Primary Outcomes (1)

  • Achievement level of patients' individual satisfaction

    At weeks 4 and 12

Secondary Outcomes (3)

  • Changes in urgency episodes

    At weeks 4 and 12

  • Changes in OAB symptom scores

    At weeks 4 and 12

  • Changes in QoL score by OAB-q

    At weeks 4 and 12

Study Arms (2)

Alpha blocker and placebo

PLACEBO COMPARATOR
Drug: Alpha blockerDrug: placebo

Alpha blocker and solifenacin

EXPERIMENTAL
Drug: Alpha blockerDrug: solifenacin

Interventions

Alpha blockerDRUG

oral

Alpha blocker and placeboAlpha blocker and solifenacin
placeboDRUG

oral

Alpha blocker and placebo
solifenacinDRUG

oral

Also known as: Vesicare, YM905
Alpha blocker and solifenacin

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
  • symptoms of urinary urgency (defined as a level of \>=3 in a 5 point urgency scale) at least two episode per 24 hours and
  • symptoms of urinary frequency ( \>8 micturitions per 24 hours)
  • On a stable dose of tamsulosin for at least 1 month

You may not qualify if:

  • Previous history of acute urinary retention
  • Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
  • Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  • Symptomatic acute urinary tract infection (UTI) during the screening period
  • Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
  • A 5-alpha reductase inhibitor if started less than 3 months prior to screening
  • Patients with previous urethral, prostate or bladder neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Cheonan, South Korea

Location

Unknown Facility

Pusan, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Adrenergic alpha-AntagonistsSolifenacin Succinate

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 Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsQuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 17, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

KR(3)