Prostatic HyperplasiaNCT02244268
Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- ALNA®
- How many people
- 3,629 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Dec 2001
- 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 suffering from symptomatic benign prostatic hyperplasia (BPH) syndrome recruited in urological practices
Who may be able to join
- Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information
Who cannot join
- No exclusion criteria is defined, prescribing information is to be considered
About this study
Official title: Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome
The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.
- Conditions
- Prostatic Hyperplasia
- Being tested
- ALNA®
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALNA®Drug
Also called tamsulosin
| Study group | Role | What they receive |
|---|---|---|
| Patient with symptomatic of benign prostatic hyperplasia | Not described Receives: Drug: ALNA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in obstructive BPH symptoms
Measured: up to 12 weeks
Change in irritative BPH symptoms
Measured: up to 12 weeks
Secondary outcomes (7)
Change in Residual Urine volume
Measured: up to 12 weeks
Number of patients with adverse events
Measured: up to 12 weeks
Assessment of the number of days on sick leave
Measured: up to 12 weeks
Global assessment of efficacy by investigator on a 4-point scale
Measured: after 12 weeks
Change in Quality-of-Life Index
Measured: up to 12 weeks
Global assessment of tolerability by investigator on a 4-point scale
Measured: after 12 weeks
Changes in urinary flow rate
Measured: up to 12 weeks
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 startOct 2000
- Primary completionDec 2001
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
- 3,629 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
- NCT02244268
- Sponsor's protocol ID
- 527.20
- 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
- Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome
- ClinicalTrials.gov ID
- NCT02244268
- Acronym / sponsor ID
- 527.20
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,629 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Dec 2001 (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 aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with symptomatic of benign prostatic hyperplasia | – | Drug: ALNA® |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from symptomatic benign prostatic hyperplasia (BPH) syndrome recruited in urological practices
Key inclusion criteria (1 listed)
- Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information
Key exclusion criteria (1 listed)
- No exclusion criteria is defined, prescribing information is to be considered
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 |
|---|---|---|
| ALNA®Also: tamsulosin | Drug | Patient with symptomatic of benign prostatic hyperplasia |
Primary outcome
Change in obstructive BPH symptoms
Time frame: up to 12 weeks
Change in irritative BPH symptoms
Time frame: up to 12 weeks
7 secondary outcomes
Change in Residual Urine volume
Time frame: up to 12 weeks
Number of patients with adverse events
Time frame: up to 12 weeks
Assessment of the number of days on sick leave
Time frame: up to 12 weeks
Global assessment of efficacy by investigator on a 4-point scale
Time frame: after 12 weeks
Change in Quality-of-Life Index
Time frame: up to 12 weeks
Global assessment of tolerability by investigator on a 4-point scale
Time frame: after 12 weeks
Changes in urinary flow rate
Time frame: up to 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 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 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 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?
Change in obstructive BPH symptoms (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. 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.