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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Samsung Medical Center
Seoul National University Hospital
Bucheon St.Mary's Hospital
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: February 11, 2013
Last verified: February 2013
History of Changes

September 20, 2011
February 11, 2013
September 2011
August 2013   (final data collection date for primary outcome measure)
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
The changes of the total score in Xerostomia inventory XI from baseline [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
The changes of the total score in Xerostomia inventory XI from baseline
Complete list of historical versions of study NCT01437670 on ClinicalTrials.gov Archive Site
  • 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)
Not Provided
Not Provided
Not Provided
 
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

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

To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
Overactive Bladder
Drug: solifenacin 5mg, 10mg
solifenacin 5mg, 10mg
Other Name: Vesicare
dry mouth patients with solifenacin
dry mouth patients with solifenacin 5mg, 10mg
Intervention: Drug: solifenacin 5mg, 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
262
December 2013
August 2013   (final data collection date for primary outcome measure)

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)
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01437670
AMC 2011-0585
Yes
Myung-Soo Choo, Asan Medical Center
Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Bucheon St.Mary's Hospital
  • Ajou University
  • Severance Hospital
  • Cheil General Hospital and Women’s Healthcare Center
  • SMG-SNU Boramae Medical Center
  • Pusan National University Yangsan Hospital
Principal Investigator: Myoung-Soo Choo, M.D., pH.D. Asan Medical Center
Asan Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP