Overactive BladderOABNCT01437670
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
An observational study of Overactive Bladder, run by Asan Medical Center at 1 site in South Korea.
Trial summary
A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- solifenacin 5mg, 10mg
- How many people
- 262 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin
- Conditions
- Overactive Bladder
- Being tested
- solifenacin 5mg, 10mg
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin 5mg, 10mgDrug
Also called Vesicare
solifenacin 5mg, 10mg
| Study group | Role | What they receive |
|---|---|---|
| dry mouth patients with solifenacin | dry mouth patients with solifenacin 5mg, 10mg Receives: Drug: solifenacin 5mg, 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 8 weeks of treatment from baseline
Secondary outcomes (3)
Global response assessment
range, 1~7
Measured: after 8 weeks of treatment from baseline
The changes of the total score in overactive bladder symptom score (OABSS) from baseline
total best and worst values: 0 and 15
Measured: after 8 weeks treatment from baseline
Visual Analog Scale (VAS) of dry mouth
The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0~10)
Measured: after 8 weeks treatment from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Myung-Soo Choo, Asan Medical Center
- Investigators
- Myoung-Soo Choo, M.D., pH.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437670
- Sponsor's protocol ID
- AMC 2011-0585
- Acronym
- OAB
- Status last verified
- May 2014
- First submitted
- 20 Sep 2011
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
- ClinicalTrials.gov ID
- NCT01437670
- Acronym / sponsor ID
- OAB / AMC 2011-0585
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- 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
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dry mouth patients with solifenacin | – | Drug: solifenacin 5mg, 10mgdry mouth patients with solifenacin 5mg, 10mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solifenacin 5mg, 10mgAlso: Vesicaresolifenacin 5mg, 10mg | Drug | dry mouth patients with solifenacin |
Primary outcome
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
3 secondary outcomes
Global response assessment
Time frame: after 8 weeks of treatment from baseline
The changes of the total score in overactive bladder symptom score (OABSS) from baseline
Time frame: after 8 weeks treatment from baseline
Visual Analog Scale (VAS) of dry mouth
Time frame: after 8 weeks treatment from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myoung-Soo Choo, M.D., pH.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of the total score in Xerostomia inventory XI from baseline (time frame: after 8 weeks of treatment from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.