- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00699049
A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
January 6, 2016 updated by: KYU-SUNG LEE
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker
The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cheonan, Korea, Republic of
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Pusan, Korea, Republic of
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Seoul, Korea, Republic of
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
- symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and
- symptoms of urinary frequency ( >8 micturitions per 24 hours)
- On a stable dose of tamsulosin for at least 1 month
Exclusion Criteria:
- Previous history of acute urinary retention
- Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the screening period
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
- A 5-alpha reductase inhibitor if started less than 3 months prior to screening
- Patients with previous urethral, prostate or bladder neck surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Alpha blocker and placebo
|
oral
oral
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Experimental: Alpha blocker and solifenacin
|
oral
Other Names:
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Achievement level of patients' individual satisfaction
Time Frame: At weeks 4 and 12
|
At weeks 4 and 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in urgency episodes
Time Frame: At weeks 4 and 12
|
At weeks 4 and 12
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Changes in OAB symptom scores
Time Frame: At weeks 4 and 12
|
At weeks 4 and 12
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Changes in QoL score by OAB-q
Time Frame: At weeks 4 and 12
|
At weeks 4 and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
June 16, 2008
First Submitted That Met QC Criteria
June 16, 2008
First Posted (Estimate)
June 17, 2008
Study Record Updates
Last Update Posted (Estimate)
January 7, 2016
Last Update Submitted That Met QC Criteria
January 6, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Solifenacin Succinate
- Adrenergic alpha-Antagonists
Other Study ID Numbers
- SMK-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on solifenacin
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Astellas Pharma Europe Ltd.CompletedOveractive Bladder (OAB) | Lower Urinary Tract Symptoms (LUTS)Ireland
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Astellas Pharma IncCompletedHealthy Volunteers | Pharmacokinetics of Solifenacin Succinate | Bioavailability of Solifenacin SuccinateUnited States
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Hanmi Pharmaceutical Company LimitedCompleted
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Astellas Pharma IncCompletedUrinary Bladder, OveractiveSweden, United Kingdom, Belgium, Denmark
-
Astellas Pharma Europe B.V.CompletedUrinary Bladder, OveractiveBelgium, United States, Brazil, Canada, Denmark, Former Serbia and Montenegro, Korea, Republic of, Mexico, Norway, Philippines, Poland, South Africa, Sweden, Turkey, Ukraine, United Kingdom
-
Center Eugene MarquisTerminated
-
Lahey ClinicAstellas Pharma US, Inc.TerminatedOveractive BladderUnited States
-
National Taiwan University HospitalUnknownOveractive Bladder SyndromeTaiwan
-
Astellas Pharma IncCompletedHealthy Volunteers | Pharmacokinetics of Solifenacin SuccinateUnited States