Lower Urinary Tract Symptoms Associated With Benign Prostatic HyperplasiaPhase 4NCT01922375
Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
A Phase 4 study testing Naftopidil in people with Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia. 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 Associated With Benign Prostatic Hyperplasia
- What is being tested?
- Naftopidil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 411 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Sep 2012
- 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
- Male patients aged 4 years or more diagnosed with BPH
Who cannot join
- subjects with uncontrolled blood pressure
- subjects with hepatic or renal dysfunction
- subjects with prostate cancer
- Had treatments for BPH using other alpha receptor antagonists within 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Design Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.
The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty.
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
- Being tested
- Naftopidil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaftopidilDrug
| Study group | Role | What they receive |
|---|---|---|
| Naftopidil dose 2 | Experimental | PO administration Receives: Drug: Naftopidil |
| Placebo | Placebo comparator | PO administration |
| Naftopidil dose 1 | Experimental | PO administration Receives: Drug: Naftopidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy(IPSS score change)
Measured: From 0 week(baseline) to 12 week(end of the treatment)
Secondary outcomes (1)
Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)
Measured: From 0 week(baseline) to 12 week(end of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Symptoms Associated With 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sae-Woong Kim, MD.PhD, Principal investigator, Seoul St. Mary's HospitalJae-Seok Hyun, Md, PhD, Principal investigator, Gyeongsang National University HospitalDu-Geon Moon, MD, PhD, Principal investigator, Korea University Guro HospitalNam-Cheol Park, MD, PhD, Principal investigator, Pusan National University HospitalSung-Won Lee, MD, PhD, Principal investigator, Samsung Medical CenterSoo-Woong Kim, Md, PhD, Principal investigator, Seoul National University HospitalTai-Young Ahn, Md, PhD, Principal investigator, Asan Medical CenterKi-Hak Moon, Md, PhD, Principal investigator, Yeongnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922375
- Sponsor's protocol ID
- FLV_BPH_IV-1
- Status last verified
- Aug 2013
- First submitted
- 11 Feb 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Design Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT01922375
- Acronym / sponsor ID
- FLV_BPH_IV-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Aug 2013 (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 study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.
The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty.
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naftopidil dose 2 | Experimental | Drug: NaftopidilPO administration |
| Placebo | Placebo comparator | –PO administration |
| Naftopidil dose 1 | Experimental | Drug: NaftopidilPO administration |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients aged 4 years or more diagnosed with BPH
Key exclusion criteria (4 listed)
- subjects with uncontrolled blood pressure
- subjects with hepatic or renal dysfunction
- subjects with prostate cancer
- Had treatments for BPH using other alpha receptor antagonists within 2 weeks
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 |
|---|---|---|
| Naftopidil | Drug | Naftopidil dose 1, Naftopidil dose 2 |
Primary outcome
Efficacy(IPSS score change)
Time frame: From 0 week(baseline) to 12 week(end of the treatment)
1 secondary outcome
Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)
Time frame: From 0 week(baseline) to 12 week(end of the treatment)
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 14 Aug 2013.
Related trials for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruitingPhase 4
Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.
Benign Prostatic Hyperplasia (BPH), Obstructive Lower Urinary Tract Symptoms (LUTS)
RecruitingObservational study
Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
BPH (Benign Prostatic Hyperplasia)
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.
Sae-Woong Kim, MD.PhD principal investigator
Seoul St. Mary's Hospital
Jae-Seok Hyun, Md, PhD principal investigator
Gyeongsang National University Hospital
Du-Geon Moon, MD, PhD principal investigator
Korea University Guro Hospital
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 Naftopidil in people with Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia, run by Dong-A Pharmaceutical Co., Ltd. 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 4 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 14 Aug 2013. 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. Some participants in this study may receive a placebo. 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?
Efficacy(IPSS score change) (time frame: From 0 week(baseline) to 12 week(end of the treatment)). 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 14 Aug 2013.