Prostatic HyperplasiaNCT02245529
Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Tamsulosin
- How many people
- 982 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Sep 2005
- 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 a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) who require medical treatment to improve their quality of life
Who may be able to join
- Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information
Who cannot join
- Patients with known hypersensitivity to Tamsulosin, or any other component of the product
- Patients with a history of orthostatic hypotension or severe liver failure
About this study
Official title: Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)
The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice
- Conditions
- Prostatic Hyperplasia
- Being tested
- Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Secotex ®
| Study group | Role | What they receive |
|---|---|---|
| Patients with benign prostatic hyperplasia (BPH) | Not described Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 6 months
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 startMar 2005
- Primary completionSep 2005
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
- 982 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
- NCT02245529
- Sponsor's protocol ID
- 527.64
- 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
- Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT02245529
- Acronym / sponsor ID
- 527.64
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 982 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Sep 2005 (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 Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with benign prostatic hyperplasia (BPH) | – | Drug: Tamsulosin |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) who require medical treatment to improve their quality of life
Key inclusion criteria (1 listed)
- Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information
Key exclusion criteria (2 listed)
- Patients with known hypersensitivity to Tamsulosin, or any other component of the product
- Patients with a history of orthostatic hypotension or severe liver failure
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 |
|---|---|---|
| TamsulosinAlso: Secotex ® | Drug | Patients with benign prostatic hyperplasia (BPH) |
Primary outcome
Number of patients with adverse events
Time frame: up to 6 months
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 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 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?
Number of patients with adverse events (time frame: up to 6 months). 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.