Lower Urinary Tract SymptomsPhase 4NCT02715024
Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
A Phase 4 study testing Tamsulosin and Solifenacin in people with Lower Urinary Tract Symptoms and Overactive Bladder, run by Astellas Pharma Taiwan, Inc. at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin alone or in combination with solifenacin for the treatment in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Overactive Bladder, Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Tamsulosin and Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Apr 2011
- Phase
- Phase 4
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
- I-PSS(S) score of ≥ 12
- Maximum flow rate (Qmax) of 4 to15 mL/sec
- Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
- Benign digital rectal examination (DRE) result
Who cannot join
- Clinically significant outflow obstruction
- Significant post void residue volume (PVR >100ml)
- Prostate specific antigen (PSA) ≥10 ng/mL
- Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
- Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
- Patient with a neurological cause for abnormal detrusor activity
Show all 15Show fewer
- Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
- Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
- Patients with any other complication which may cause voiding dysfunction
- Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
- Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
- Use of drugs to treat incontinence currently
- Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
- Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
- Patients had taken any investigational drug in the previous 3 months prior to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin alone or in combination with solifenacin for the treatment in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.
- Being tested
- Tamsulosin, Solifenacin
- Keywords
- Tamsulosin, Solifenacin, Lower urinary tract symptoms, Overactive bladder
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Overactive, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Harnalidge® D
Oral
SolifenacinDrug
Also called Vesicare®
Oral
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin alone | Experimental | Not described Receives: Drug: Tamsulosin |
| Tamsulosin + solifenacin | Experimental | Not described Receives: Drug: Tamsulosin; Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment
Measured: Baseline and end of treatment (up to 12 weeks)
Secondary outcomes (8)
Change in mean number of urgency episode per 24 hours from baseline to the end of treatment
Measured: Baseline and end of treatment (up to 12 weeks)
Change in mean number of micturitions per 24 hours from baseline to the end of treatment
Measured: Baseline and end of treatment (up to 12 weeks)
Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment
Measured: Baseline and end of treatment (up to 12 weeks)
Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment
Measured: Baseline and end of treatment (up to 12 weeks)
Safety as assessed by adverse events
Measured: Up to 12 weeks
Safety as assessed by postvoid residual volume (PVR)
Measured by bladder scan
Measured: Up to 12 weeks
Safety as assessed by vital signs
Measured: Up to 12 weeks
Safety as assessed by laboratory parameters
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startSep 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Taiwan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Therapeutic Area Lead of Medical Affairs (Asia-Oceania), Study director, Astellas Pharma Taiwan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715024
- Sponsor's protocol ID
- HAURO-0605-TW
- Status last verified
- Mar 2016
- First submitted
- 17 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
- ClinicalTrials.gov ID
- NCT02715024
- Acronym / sponsor ID
- HAURO-0605-TW
- Keywords
- Tamsulosin, Solifenacin, Lower urinary tract symptoms, Overactive bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Astellas Pharma Taiwan, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Mar 2016 (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.
The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin alone or in combination with solifenacin for the treatment in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin alone | Experimental | Drug: Tamsulosin |
| Tamsulosin + solifenacin | Experimental | Drug: Tamsulosin, Drug: Solifenacin |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
- I-PSS(S) score of ≥ 12
- Maximum flow rate (Qmax) of 4 to15 mL/sec
- Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
- Benign digital rectal examination (DRE) result
Key exclusion criteria (15 listed)
- Clinically significant outflow obstruction
- Significant post void residue volume (PVR >100ml)
- Prostate specific antigen (PSA) ≥10 ng/mL
- Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
- Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
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 |
|---|---|---|
| TamsulosinAlso: Harnalidge® DOral | Drug | Tamsulosin + solifenacin, Tamsulosin alone |
| SolifenacinAlso: Vesicare®Oral | Drug | Tamsulosin + solifenacin |
Primary outcome
Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment
Time frame: Baseline and end of treatment (up to 12 weeks)
8 secondary outcomes
Change in mean number of urgency episode per 24 hours from baseline to the end of treatment
Time frame: Baseline and end of treatment (up to 12 weeks)
Change in mean number of micturitions per 24 hours from baseline to the end of treatment
Time frame: Baseline and end of treatment (up to 12 weeks)
Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment
Time frame: Baseline and end of treatment (up to 12 weeks)
Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment
Time frame: Baseline and end of treatment (up to 12 weeks)
Safety as assessed by adverse events
Time frame: Up to 12 weeks
Safety as assessed by postvoid residual volume (PVR)
Time frame: Up to 12 weeks
Safety as assessed by vital signs
Time frame: Up to 12 weeks
Safety as assessed by laboratory parameters
Time frame: Up to 12 weeks
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 22 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
Therapeutic Area Lead of Medical Affairs (Asia-Oceania) study director
Astellas Pharma Taiwan, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin and Solifenacin in people with Lower Urinary Tract Symptoms and Overactive Bladder, run by Astellas Pharma Taiwan, Inc. at 1 site in Taiwan.
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 5 inclusion and 15 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 22 Mar 2016. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment (time frame: Baseline and end of treatment (up to 12 weeks)). 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 22 Mar 2016.