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Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

NCT ID: NCT01437670

Last Updated: 2014-05-30

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

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin

Detailed Description

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To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin

Conditions

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Overactive Bladder

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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dry mouth patients with solifenacin

dry mouth patients with solifenacin 5mg, 10mg

solifenacin 5mg, 10mg

Intervention Type DRUG

solifenacin 5mg, 10mg

Interventions

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solifenacin 5mg, 10mg

solifenacin 5mg, 10mg

Intervention Type DRUG

Other Intervention Names

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Vesicare

Eligibility Criteria

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Inclusion Criteria

* 1\) male or female patients with 20 years of age or older 2) clinical history of OAB for at least 3 months prior to visit 2 3) more than 3 in total score and 2 in Q 3 index from OABSS questionnaire

Exclusion Criteria

* 1\) In clinical trial, female with pregnant, intent to become pregnant or breast-feeding 2)post-voided residual urine volume \> 150ml 3) a history of catheterization due to acute urinary retention 4) a history of pelvic surgery within 6 months 5) 6) 7) a history of neurovascular disease such as Parkinson's disease, cerebral vascular disease, spinal injury or multiple sclerosis 8)patients with indwelling catheter or intermittent catheterization 9) active or recurrent (\>3 episodes per year) urinary tract infection 10) the use of the following medication at least 2 weeks
* anticholinergics
* Tricyclic antidepressants,anti-epilepsy drug, anti-Parkinson's disease drug, anti-arrythmia drug type I
* Chlorpromazine, Thioridazine, Piperazine
* MAO inhibitor 11) Patient is currently taking or has taken within the past 4 weeks alpha-blocker for the treatment of benign prostatic hypertrophy 12) Patient is currently taking or has taken within the past 8 weeks 5ARI or estrogen medication 13) Patient is currently using or has used medications with known activities as inhibitors or inducers of cytochrome P4503A4 (CYP3A4)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role collaborator

Ajou University

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Cheil General Hospital and Women's Healthcare Center

OTHER

Sponsor Role collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Pusan National University Yangsan Hospital

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Myung-Soo Choo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myoung-Soo Choo, M.D., pH.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMC 2011-0585

Identifier Type: -

Identifier Source: org_study_id