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Reproducibility Study of OABSS and Its Response to Treatment

NCT ID: NCT02667470

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder

Keywords

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Solifenacin Overactive bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Solifenacin

Group Type EXPERIMENTAL

Solifenacin

Intervention Type DRUG

Oral

Interventions

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Solifenacin

Oral

Intervention Type DRUG

Other Intervention Names

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Vesicare

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Site: 1

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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ATH-002

Identifier Type: -

Identifier Source: org_study_id