Benign Prostatic HyperplasiaPhase 4NCT00379067
A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
A Phase 4 study testing Tamsulosin OCAS in people with Benign Prostatic Hyperplasia, run by Astellas Pharma Inc.
Trial summary
Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg \& placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tamsulosin OCAS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 882 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Nov 2006
- 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
- Diagnosed as having LUTS associated with BPH
- On average, at least 2 voids per night over the last week
- A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)
Who cannot join
- Subject is currently taking diuretics
- Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg \& placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tamsulosin OCAS, Placebo
- Keywords
- Benign Prostatic Hyperplasia, Nocturia, Actigraphy, Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin OCASDrug
Adrenoceptor antagonist
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Tamsulosin OCAS tablet Receives: Drug: Tamsulosin OCAS |
| 2 | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline to week 12 in mean number of nocturnal voids
Measured: 12 weeks
Secondary outcomes (1)
The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startOct 2005
- Primary completionNov 2006
- Study completionNov 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe Ltd., Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379067
- Sponsor's protocol ID
- 617-EC-006
- Status last verified
- Oct 2014
- First submitted
- 19 Sep 2006
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00379067
- Acronym / sponsor ID
- 617-EC-006
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, Nocturia, Actigraphy, Tamsulosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 882 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe Ltd., Boehringer Ingelheim
- Study start
- Oct 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 21 Sep 2006 (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.
Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg \& placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tamsulosin OCASTamsulosin OCAS tablet |
| 2 | Placebo comparator | Drug: PlaceboPlacebo tablet |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as having LUTS associated with BPH
- On average, at least 2 voids per night over the last week
- A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)
Key exclusion criteria (2 listed)
- Subject is currently taking diuretics
- Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
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 |
|---|---|---|
| Tamsulosin OCASAdrenoceptor antagonist | Drug | 1 |
| Placeboplacebo | Drug | 2 |
Primary outcome
The change from baseline to week 12 in mean number of nocturnal voids
Time frame: 12 weeks
1 secondary outcome
The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void
Time frame: 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 10 Oct 2014.
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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.
Use Central Contact study director
Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin OCAS in people with Benign Prostatic Hyperplasia, run by Astellas Pharma Inc.
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 3 inclusion and 2 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 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The change from baseline to week 12 in mean number of nocturnal voids (time frame: 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 10 Oct 2014.