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Trial record 11 of 714 for:    dry mouth

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

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ClinicalTrials.gov Identifier: NCT01437670
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : May 30, 2014
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

Tracking Information
First Submitted Date September 20, 2011
First Posted Date September 21, 2011
Last Update Posted Date May 30, 2014
Study Start Date September 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2011)
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
Original Primary Outcome Measures
 (submitted: September 20, 2011)
The changes of the total score in Xerostomia inventory XI from baseline [ Time Frame: after 8 weeks of treatment ]
The changes of the total score in Xerostomia inventory XI from baseline
Change History Complete list of historical versions of study NCT01437670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 11, 2013)
  • Global response assessment [ Time Frame: after 8 weeks of treatment from baseline ]
    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 ]
    total best and worst values: 0 and 15
  • 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)
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
Official Title A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
Brief Summary A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin
Detailed Description To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Overactive Bladder
Intervention Drug: solifenacin 5mg, 10mg
solifenacin 5mg, 10mg
Other Name: Vesicare
Study Groups/Cohorts dry mouth patients with solifenacin
dry mouth patients with solifenacin 5mg, 10mg
Intervention: Drug: solifenacin 5mg, 10mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 11, 2013)
262
Original Estimated Enrollment
 (submitted: September 20, 2011)
180
Actual Study Completion Date December 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01437670
Other Study ID Numbers AMC 2011-0585
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Myung-Soo Choo, Asan Medical Center
Study Sponsor Asan Medical Center
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
Investigators
Principal Investigator: Myoung-Soo Choo, M.D., pH.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date May 2014