Benign Prostatic HyperplasiaPhase 4STRONGNCT01259531
Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)
A Phase 4 study testing Silodosin in people with Benign Prostatic Hyperplasia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Silodosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Sep 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 50 years old
- Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher
- Has a QoL score of 3 or higher
- Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec
- Has a PRV of below 100mL
- Voluntarily decides to participate in this trial and sign with informed consent form
Who cannot join
- Has been administered silodosin
- Has been administered an α1A-adrenoceptor blocker within one month
- Has been prescribed antiandrogens except 5α-reductase inhibitors within a year
- Has had phytotherapy within 3 months
- Has had prostatectomy
- Has had intrapelvic radiation therapy
Show all 17Show fewer
- Has had transurethral microwave hyperthermia of transurethral needle ablation
- Is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (UTI).
- Is conducting self-catherterization
- Has a renal impairment with a serum creatinine of 2.0mg/dL or greater
- Has severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or has a total bilirubin of 2.5mg/dl or higher or has AST/ALT 2.5 times higher than the normal (upper) level
- Has suffered from a severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- Has experienced allergy to α1 receptor blockers
- Has orthostatic hypotension around the time of Screening Visit
- Has participated in other clinical trials within 8 weeks prior to Screening Visit
- Has a Prostate specific antigen(PSA) of higher 10ng/mL or has been diagnosed with tumor identified by a biopsy even though he has a PSA of lower 10ng/mL (Patient who has been administered 5α-reductase inhibitors for more than 3 months are presumed to have 2 times higher than their actual PSA levels)
- Has been taking unstable dosing of 5α-reductase inhibitors like finasteride or dutasteride for the past 3 months or is expected to change the dosage during the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week, Open Label, Multi-center Study to Investigate the Efficacy and Safety of a α1A Adrenoceptor Selective Antagonist Silodosin on Urinary Disturbance Associated With Benign Prostatic Hyperplasia
This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Silodosin
- Keywords
- strong, silodosin, benign prostatic hyperplasia, BPH, lower urinary tract symptoms associated with severe BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Also called Brand name in Korea : THRUPAS
Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Experimental | Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal. Receives: Drug: Silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total International prostate symptom score(IPSS) score before and after treatment
Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment.
Measured: For 12 weeks
Secondary outcomes (5)
Quality of life(QoL) score before and after treatment
Assess the improvement of lower urinary tract symptoms with change in QoL score before and after treatment.
Measured: For 12 weeks
Maximal urinary flow rate(Qmax) before and after treatment
Assess the improvement of lower urinary tract symptoms with change in Qmax before and after treatment.
Measured: For 12 weeks
Voiding score of IPSS before and after treatment
Assess the improvement of lower urinary tract symptoms with change in voiding scores before and after treatment.
Measured: For 12 weeks
Storage scores of IPSS before and after treatment
Assess the improvement of lower urinary tract symptoms with change in storage scores before and after treatment.
Measured: For 12 weeks
Post void residual urine volume(PVR) before and after treatment
Assess the improvement of lower urinary tract symptoms with change in post void residual urine volume(PRV) before and after treatment.
Measured: For 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chonnam National University Hospital, Kangdong Sacred Heart Hospital, Yeungnam University Hospital, Pusan National University Hospital, Seoul National University Hospital, Samsung Medical Center, Seoul St. Mary's Hospital, Korea University Guro Hospital, Chonbuk National University Hospital, Asan Medical Center
- Responsible party
- Sponsor
- Investigators
- G.S. Park, Prof, Study chair, Chonnam National Univ.D.Y. Yang, Prof, Principal investigator, Kangdong Sacred HeartK.H. Moon, Prof, Principal investigator, Yeongnam Univ. MedicalN.C. Park, Principal investigator, Pusan National Univ. HospitalS.W. Kim, Prof, Principal investigator, Seoul National Univ. HospitalS.W. Lee, Prof, Principal investigator, Samsung Medical CenterS.W. Kim, Prof, Principal investigator, Seoul St. Mary's HospitalD.G. Moon, Prof, Principal investigator, Korea Univ. Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259531
- Sponsor's protocol ID
- CWP-SDS-403
- Acronym
- STRONG
- Status last verified
- Mar 2012
- First submitted
- 7 Dec 2010
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Open Label, Multi-center Study to Investigate the Efficacy and Safety of a α1A Adrenoceptor Selective Antagonist Silodosin on Urinary Disturbance Associated With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT01259531
- Acronym / sponsor ID
- STRONG / CWP-SDS-403
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- strong, silodosin, benign prostatic hyperplasia, BPH, lower urinary tract symptoms associated with severe BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Chonnam National University Hospital, Kangdong Sacred Heart Hospital, Yeungnam University Hospital, Pusan National University Hospital, Seoul National University Hospital, Samsung Medical Center, Seoul St. Mary's Hospital, Korea University Guro Hospital, Chonbuk National University Hospital, Asan Medical Center
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Dec 2010 (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.
This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Experimental | Drug: SilodosinSilodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is at least 50 years old
- Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher
- Has a QoL score of 3 or higher
- Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec
- Has a PRV of below 100mL
Key exclusion criteria (17 listed)
- Has been administered silodosin
- Has been administered an α1A-adrenoceptor blocker within one month
- Has been prescribed antiandrogens except 5α-reductase inhibitors within a year
- Has had phytotherapy within 3 months
- Has had prostatectomy
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 |
|---|---|---|
| SilodosinAlso: Brand name in Korea : THRUPASSilodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal. | Drug | Silodosin |
Primary outcome
Total International prostate symptom score(IPSS) score before and after treatment
Time frame: For 12 weeks
Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment.
5 secondary outcomes
Quality of life(QoL) score before and after treatment
Time frame: For 12 weeks
Maximal urinary flow rate(Qmax) before and after treatment
Time frame: For 12 weeks
Voiding score of IPSS before and after treatment
Time frame: For 12 weeks
Storage scores of IPSS before and after treatment
Time frame: For 12 weeks
Post void residual urine volume(PVR) before and after treatment
Time frame: For 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 30 Mar 2012.
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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.
G.S. Park, Prof study chair
Chonnam National Univ.
D.Y. Yang, Prof principal investigator
Kangdong Sacred Heart
K.H. Moon, Prof principal investigator
Yeongnam Univ. Medical
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 Silodosin in people with Benign Prostatic Hyperplasia, run by JW Pharmaceutical 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 6 inclusion and 17 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 Mar 2012. 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.
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?
Total International prostate symptom score(IPSS) score before and after treatment (time frame: For 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 30 Mar 2012.