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

This study has been completed.
Sponsor:
Collaborators:
Samsung Medical Center
Seoul National University Hospital
The Catholic University of Korea
Ajou University
Severance Hospital
Cheil General Hospital and Women’s Healthcare Center
SMG-SNU Boramae Medical Center
Pusan National University Yangsan Hospital
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01437670
First received: September 20, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Overactive Bladder
Drug: solifenacin 5mg, 10mg

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • The changes of the total score in Xerostomia inventory XI from baseline [ Time Frame: after 8 weeks of treatment from baseline ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Global response assessment [ Time Frame: after 8 weeks of treatment from baseline ] [ Designated as safety issue: No ]
    range, 1~7

  • The changes of the total score in overactive bladder symptom score (OABSS) from baseline [ Time Frame: after 8 weeks treatment from baseline ] [ Designated as safety issue: No ]
    total best and worst values: 0 and 15

  • Visual Analog Scale (VAS) of dry mouth [ Time Frame: after 8 weeks treatment from baseline ] [ Designated as safety issue: No ]
    The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0~10)


Enrollment: 262
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
dry mouth patients with solifenacin
dry mouth patients with solifenacin 5mg, 10mg
Drug: solifenacin 5mg, 10mg
solifenacin 5mg, 10mg
Other Name: Vesicare

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437670

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-222
Sponsors and Collaborators
Asan Medical Center
Samsung Medical Center
Seoul National University Hospital
The Catholic University of Korea
Ajou University
Severance Hospital
Cheil General Hospital and Women’s Healthcare Center
SMG-SNU Boramae Medical Center
Pusan National University Yangsan Hospital
Investigators
Principal Investigator: Myoung-Soo Choo, M.D., pH.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Myung-Soo Choo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01437670     History of Changes
Other Study ID Numbers: AMC 2011-0585
Study First Received: September 20, 2011
Last Updated: May 28, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Solifenacin
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 23, 2014