NCT02667470

Brief Summary

The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

September 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

3.7 years

First QC Date

January 26, 2016

Last Update Submit

January 26, 2016

Conditions

Overactive Bladder

Keywords

SolifenacinOveractive bladder

Outcome Measures

Primary Outcomes (1)

  • Change in OABSS scores from prior to treatment and after treatment

    Prior to treatment and after treatment (up to 12 weeks)

Secondary Outcomes (9)

  • Correlation of change between OABSS scores and number of micturitions per day

    Prior to treatment and after treatment (up to 12 weeks)

  • Correlation of change between OABSS scores and number of incontinence episodes per day

    Prior to treatment and after treatment (up to 12 weeks)

  • Correlation of change between OABSS scores and number of urgency episodes per day

    Prior to treatment and after treatment (up to 12 weeks)

  • Correlation of change between OABSS scores and number of nocturia episodes per day

    Prior to treatment and after treatment (up to 12 weeks)

  • Correlation of change between OABSS scores and number of total voided volume per day

    Prior to treatment and after treatment (up to 12 weeks)

  • +4 more secondary outcomes

Study Arms (1)

Solifenacin

EXPERIMENTAL
Drug: Solifenacin

Interventions

SolifenacinDRUG

Oral

Also known as: Vesicare
Solifenacin

Eligibility Criteria

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

You may qualify if:

  • At screening visit (Week -2):
  • Symptoms of OAB ≥ 3 months
  • Number of urgency episodes in last 3 days ≥ 3
  • Based on the 3-day micturition diary prior to Visit 1 (Week 0):
  • Number of micturition per day ≥ 8
  • Number of urgency episodes in 3 days ≥ 3

You may not qualify if:

  • At screening visit (Week -2):
  • Stress is the predominant factor as determined by the investigator
  • Indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Treatment for OAB was started, quitted or changed in 4 weeks
  • Diabetic neuropathy
  • At Visit 1 (Week 0):
  • Patient who did not complete the 3-day micturition diary according to the instruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site: 1

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin 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)

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

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

September 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

TH(1)