Benign Prostatic Hyperplasia (BPH)Phase 2NCT01222650
A Comparative Study of KSO-0400 in BPH Patients With LUTS
A Phase 2 study testing KSO-0400 and Silodosin in people with Benign Prostatic Hyperplasia (BPH), run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by 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 (BPH)
- What is being tested?
- KSO-0400 and Silodosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- BPH patients with LUTS
Who cannot join
- Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia
- Patients with prostate cancer or suspected prostate cancer
- Patients who have any clinically relevant cardiovascular, hepatic or renal disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS
The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- KSO-0400, Silodosin, Placebo
- Keywords
- Benign Prostatic Hyperplasia, I-PSS, α1A-AR antagonist
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSO-0400Drug
KSO-0400Drug
SilodosinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KSO-0400 Low Dose | Experimental | Not described Receives: Drug: KSO-0400 |
| KSO-0400 High Dose | Experimental | Not described Receives: Drug: KSO-0400 |
| Silodosin | Experimental | Not described Receives: Drug: Silodosin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in I-PSS Total Score from baseline
Measured: Baseline and 12 weeks (LOCF)
Secondary outcomes (3)
Change in I-PSS Sub-score from baseline
Measured: Baseline and 12 weeks (LOCF)
Change in QOL Score from baseline
Measured: Baseline and 12 weeks (LOCF)
Change in Qmax (maximum urinary flow rate) from baseline
Measured: Baseline and 12 weeks (LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Katsumi Hontani, Study director, Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222650
- Sponsor's protocol ID
- KSO1201
- Status last verified
- Jun 2011
- First submitted
- 15 Oct 2010
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS
- ClinicalTrials.gov ID
- NCT01222650
- Acronym / sponsor ID
- KSO1201
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Benign Prostatic Hyperplasia, I-PSS, α1A-AR antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 18 Oct 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.
The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KSO-0400 Low Dose | Experimental | Drug: KSO-0400 |
| KSO-0400 High Dose | Experimental | Drug: KSO-0400 |
| Silodosin | Experimental | Drug: Silodosin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BPH patients with LUTS
Key exclusion criteria (3 listed)
- Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia
- Patients with prostate cancer or suspected prostate cancer
- Patients who have any clinically relevant cardiovascular, hepatic or renal disorder
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 |
|---|---|---|
| KSO-0400 | Drug | KSO-0400 Low Dose |
| KSO-0400 | Drug | KSO-0400 High Dose |
| Silodosin | Drug | Silodosin |
| Placebo | Drug | Placebo |
Primary outcome
Change in I-PSS Total Score from baseline
Time frame: Baseline and 12 weeks (LOCF)
3 secondary outcomes
Change in I-PSS Sub-score from baseline
Time frame: Baseline and 12 weeks (LOCF)
Change in QOL Score from baseline
Time frame: Baseline and 12 weeks (LOCF)
Change in Qmax (maximum urinary flow rate) from baseline
Time frame: Baseline and 12 weeks (LOCF)
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 4 Jul 2011.
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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.
Katsumi Hontani study director
Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KSO-0400 and Silodosin in people with Benign Prostatic Hyperplasia (BPH), run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
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 3 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 4 Jul 2011. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 I-PSS Total Score from baseline (time frame: Baseline and 12 weeks (LOCF)). 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 4 Jul 2011.