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

Overactive Bladder Clinical Trial

— OAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437670
• Other study ID #: AMC 2011-0585
• Status: Completed
• Phase: N/A
• First received: September 20, 2011
• Last updated: May 28, 2014
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin 5mg, 10mg
solifenacin 5mg, 10mg

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (9)

Lead Sponsor	Collaborator
Asan Medical Center	Ajou University, Cheil General Hospital and Women’s Healthcare Center, Pusan National University Yangsan Hospital, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, SMG-SNU Boramae Medical Center, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Global response assessment	range, 1~7	after 8 weeks of treatment from baseline	No
Secondary	The changes of the total score in overactive bladder symptom score (OABSS) from baseline	total best and worst values: 0 and 15	after 8 weeks treatment from baseline	No
Secondary	Visual Analog Scale (VAS) of dry mouth	The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0~10)	after 8 weeks treatment from baseline	No