Prostatic HyperplasiaNCT01376284
Drug Use Investigation for AVOLVE(BPH)
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
Trial summary
The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Dutasteride
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jun 2014
- Phase
- Observational
- 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 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese male adult subjects with benign prostatic hyperplasia (BPH) who start the treatment with dutasteride capsules
Who may be able to join
- Must be male subjects
- Use dutasteride capsules for the first time
Who cannot join
- Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
- Subjects with severe hepatic function disorder
- Dutasteride capsules shall not be used to female or child
About this study
The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Dutasteride
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Collection of safety data
| Study group | Role | What they receive |
|---|---|---|
| Subjects prescribed dutasteride capsules | Subjects with BPH prescribed dutasteride capsules during study period Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376284
- Sponsor's protocol ID
- 114125
- Status last verified
- Jul 2014
- First submitted
- 9 Jun 2011
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for AVOLVE(BPH)
- ClinicalTrials.gov ID
- NCT01376284
- Acronym / sponsor ID
- 114125
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Jun 2011 (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 study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects prescribed dutasteride capsules | – | Drug: DutasterideSubjects with BPH prescribed dutasteride capsules during study period |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese male adult subjects with benign prostatic hyperplasia (BPH) who start the treatment with dutasteride capsules
Key inclusion criteria (2 listed)
- Must be male subjects
- Use dutasteride capsules for the first time
Key exclusion criteria (3 listed)
- Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
- Subjects with severe hepatic function disorder
- Dutasteride capsules shall not be used to female or child
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 |
|---|---|---|
| DutasterideCollection of safety data | Drug | Subjects prescribed dutasteride capsules |
Primary outcome
The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
Time frame: 1 year
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 28 Jul 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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
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 2 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 28 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 number of adverse events in Japanese subjects with BPH treated with dutasteride capsules (time frame: 1 year). 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 28 Jul 2014.