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Completed

NCT Number: NCT01437670

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

solifenacin 5mg, 10mg

Drug

solifenacin 5mg, 10mg

Other names: Vesicare

Primary outcomes

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

    Time frame: after 8 weeks of treatment 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

Secondary outcomes

  1. Global response assessment

    Time frame: after 8 weeks of treatment from baseline

    range, 1~7

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

    Time frame: after 8 weeks treatment from baseline

    total best and worst values: 0 and 15

  3. Visual Analog Scale (VAS) of dry mouth

    Time frame: after 8 weeks treatment from baseline

    The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0~10)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

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

Registry information

Official study title

A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

Acronym: OAB

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2011
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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