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

NCT01437670 | Completed DMC

• 1 other identifier: AMC 2011-0585
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• The changes of the total score in Xerostomia inventory XI from baseline

  11-item summated rating scale. Respondents were asked to choose one of five responses ('never', scoring 1\~'very often', 5) total best and worst values: 11 and 49

  after 8 weeks of treatment from baseline

Secondary Outcomes (3)

• Global response assessment

  after 8 weeks of treatment from baseline

• The changes of the total score in overactive bladder symptom score (OABSS) from baseline

  after 8 weeks treatment from baseline

• Visual Analog Scale (VAS) of dry mouth

  after 8 weeks treatment from baseline

Study Arms (1)

dry mouth patients with solifenacin

dry mouth patients with solifenacin 5mg, 10mg

Drug: solifenacin 5mg, 10mg

Interventions

solifenacin 5mg, 10mg DRUG

solifenacin 5mg, 10mg

Also known as: Vesicare

dry mouth patients with solifenacin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with overactive bladder 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

You may qualify if:

• \) 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

You may not qualify if:

• \) 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)

Sponsors & Collaborators

• Asan Medical Center: lead
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator
• The Catholic University of Korea: collaborator
• Ajou University: collaborator
• Severance Hospital: collaborator
• Cheil General Hospital and Women's Healthcare Center: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Pusan National University Yangsan Hospital: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-222, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Myoung-Soo Choo, M.D., pH.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 21, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

KR (1)