Prostatic HyperplasiaNCT02244307
Observational Study in Patients Suffering From Benign Prostatic Hyperplasia Treated With Alpha-adrenergic Blockade
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
The primary objective of this observational study was the assessment of prognosis factors for having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha blockers. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- alpha-adrenergic blocker
- How many people
- 4,561 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jun 2003
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with BPH for whom alpha-blockade treatement is indicated recruited at general practitioners
Who may be able to join
- Any patient with BPH for whom alpha-blocker treatment is indicated
- Patients who are already on class-1 alpha-blockers can only participate in the study if all information required is known and/or available
Who cannot join
- Patient's follow-up not possible
- Patients participating in another study
- History of BPH surgery
- Prostate cancer
About this study
Official title: Evolution of Patients Suffering From Benign Prostatic Hyperplasia (BPH) Treated With Alpha-adrenergic Blockade (JOSEPHINE)
The primary objective of this observational study was the assessment of prognosis factors for having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha blockers. The secondary objectives were the assessment of the time from alpha-adrenergic blockade treatment initiation to surgery and the evolution of patients during the study.
- Conditions
- Prostatic Hyperplasia
- Being tested
- alpha-adrenergic blocker
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha-adrenergic blockerDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with BPH treated with alpha-andrenergic blockade | Not described Receives: Drug: alpha-adrenergic blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of prognosis factors for having recourse to prostatic surgery
Measured: up to 2 years
Secondary outcomes (4)
Time form alpha-adrenergic blockade treatment initiation to surgery
Measured: up to 2 years
Occurrence of concomitant BPH diseases
Measured: up to 2 years
Total International Prostate Symptom Score (IPSS)
Measured: up to 2 years
Percentage of patients with ongoing BPH treatment
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJan 2000
- Primary completionJun 2003
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 Boehringer IngelheimThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244307
- Sponsor's protocol ID
- 527.28
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Patients Suffering From Benign Prostatic Hyperplasia (BPH) Treated With Alpha-adrenergic Blockade (JOSEPHINE)
- ClinicalTrials.gov ID
- NCT02244307
- Acronym / sponsor ID
- 527.28
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,561 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Jun 2003 (actual)
- First posted
- 19 Sep 2014 (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 primary objective of this observational study was the assessment of prognosis factors for having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha blockers. The secondary objectives were the assessment of the time from alpha-adrenergic blockade treatment initiation to surgery and the evolution of patients during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with BPH treated with alpha-andrenergic blockade | – | Drug: alpha-adrenergic blocker |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with BPH for whom alpha-blockade treatement is indicated recruited at general practitioners
Key inclusion criteria (2 listed)
- Any patient with BPH for whom alpha-blocker treatment is indicated
- Patients who are already on class-1 alpha-blockers can only participate in the study if all information required is known and/or available
Key exclusion criteria (4 listed)
- Patient's follow-up not possible
- Patients participating in another study
- History of BPH surgery
- Prostate cancer
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 |
|---|---|---|
| alpha-adrenergic blocker | Drug | Patients with BPH treated with alpha-andrenergic blockade |
Primary outcome
Assessment of prognosis factors for having recourse to prostatic surgery
Time frame: up to 2 years
4 secondary outcomes
Time form alpha-adrenergic blockade treatment initiation to surgery
Time frame: up to 2 years
Occurrence of concomitant BPH diseases
Time frame: up to 2 years
Total International Prostate Symptom Score (IPSS)
Time frame: up to 2 years
Percentage of patients with ongoing BPH treatment
Time frame: up to 2 years
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 19 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
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 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 19 Sep 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?
Assessment of prognosis factors for having recourse to prostatic surgery (time frame: up to 2 years). 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 19 Sep 2014.