Urinary Tract DiseasesPhase 3NCT00239265
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Female Patients With Lower Urinary Tract Syndrome
A Phase 3 study testing Tamuslosin in people with Urinary Tract Diseases, run by Astellas Pharma Inc at 6 sites in Japan.
Trial summary
The purpose of this study is to determine whether Tamuslosin is effective in the treatment of lower urinary tract syndrome with female patients. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Urinary Tract Diseases
- What is being tested?
- Tamuslosin
- How many people
- Not given
- Where
- 6 sitesJapan
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with urination disorder not accompanied by apparent organic or neurologic abnormality(lower urinary tract syndrome: LUTs)．
Who cannot join
- Patients with urination disorder accompanied by apparent organic or neurologic abnormality, active urinary tract infections, severe cardiovascular, hepatic and/or kidney complications.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Touhoku Region
About this study
The purpose of this study is to determine whether Tamuslosin is effective in the treatment of lower urinary tract syndrome with female patients.
- Conditions
- Urinary Tract Diseases
- Being tested
- Tamuslosin
- Keywords
- tamsulosin, urinary tract diseases, female
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamuslosinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Director, Study chair, Clinical Development, Astellas Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239265
- Sponsor's protocol ID
- B6171/LCT2
- Status last verified
- Oct 2007
- First submitted
- 13 Sep 2005
- Last updated
- 22 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Female Patients With Lower Urinary Tract Syndrome
- ClinicalTrials.gov ID
- NCT00239265
- Acronym / sponsor ID
- B6171/LCT2
- Conditions
- Urinary Tract Diseases
- Keywords
- tamsulosin, urinary tract diseases, female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- First posted
- 17 Oct 2005 (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 purpose of this study is to determine whether Tamuslosin is effective in the treatment of lower urinary tract syndrome with female patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with urination disorder not accompanied by apparent organic or neurologic abnormality(lower urinary tract syndrome: LUTs)．
Key exclusion criteria (1 listed)
- Patients with urination disorder accompanied by apparent organic or neurologic abnormality, active urinary tract infections, severe cardiovascular, hepatic and/or kidney complications.
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 |
|---|---|---|
| Tamuslosin | Drug | – |
Primary outcome
Not reported in the source record.
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 Oct 2007.
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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.
Study Director study chair
Clinical Development, Astellas Pharma Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamuslosin in people with Urinary Tract Diseases, run by Astellas Pharma Inc at 6 sites 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 1 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 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 Oct 2007.