Prostatic HyperplasiaPhase 4NCT02245490
Study to Characterise the Effect of Tamsulosin on Lower Urinary Tract Symptoms (LUTS) and Detrusor Motor Activity in Patients Affected by Benign Prostatic Hyperplasia (BPH) and Storage Urinary Symptoms
A Phase 4 study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity in patients with LUTS suggestive of BPH and relevant storage symptoms Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Apr 2004
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male outpatients aged 50-80 years
- LUTS suggestive of BPH
- Medical history: storage symptoms (frequency, urgency) for at least 6 months
- Urinary Chart:
- At least 8 micturitions per 24 hours on average, over the week of the screening period (check urinary chart at Visit 2)
- Urgency (strong desire to void): at least once per 24 hours on average, over the week of the screening period (check urinary chart at Visit 2)
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- I-PSS ≥ 13 at randomisation (Visit 3)
- Qmax: > 4 ml/sec at randomisation (Visit 3), with a voiding volume of at least 150 ml
- Prostate Specific Antigen (PSA) < 2.5 ng/ml or between 2.5 and 10 ng/ml, if cancer is ruled out with the usual procedures of each centre (Visit 1; results before Visit 3)
- Written Informed Consent for participation to the study
Who cannot join
- Patients with a known history or a diagnosis at the time of the screening visit (Visit 1) of the following conditions:
- Urological disturbances
- Medical history of pelvic surgery
- Palpable bladder at the physical examination, or residue urinary volume > 400 ml
- Known neurological bladder disorder
- Bladder neck stenosis
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- Urethral stricture
- Bladder or prostatic cancer
- Bladder stone
- Severe diverticulum of the bladder
- Symptomatic urinary tract infection during last month, or recurrent urinary tract infections (more than 2 during last year)
- Haematuria of unknown origin
- Diseases which may affect micturition (i.e., diabetes mellitus)
- Cardiovascular diseases (if they occurred in the last 6 months)
- Myocardial infarction
- Instable angina
- Clinically significant ventricular arrhythmias
- Heart failure (NYHA classes III/IV)
- Orthostatic hypotension
- Cerebral stroke
- Neurological diseases (if their severity might compromise the correct performance of the trial)
- Senile dementia
- Multiple sclerosis
- Parkinson's disease
- Psychiatric disturbances
- Hepatic or renal insufficiency (biochemistry values 15% outside normal lab ranges, being regarded as clinically relevant by the investigator)
- Clinically significant abnormality in the haematological, blood chemistry and urinary values evidenced on the samples taken at the screening visit (Visit 1)
- Patients who are taking or have been taking α-blockers for BPH or for hypertension, or phytotherapy for BPH within the previous 6 weeks
- Patients who were taking or have been taking:
- α-blockers for BPH or for hypertension within the previous 4 weeks
- phytotherapy for BPH or mepartricin within the previous 4 weeks
- finasteride within the previous 6 months
- anticholinergics within the previous 4 weeks
- antidiuretics within the previous 4 weeks
- concomitant drugs which may influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. In particular: α-blockers and mixed α-β-blockers, α- agonists, anti-cholinergics
- Patients who are or have been taking part in a clinical study within the previous 3 months
- Patients who have had hypersensitivity or allergic reactions to previously prescribed α- blocker(s)
- Patients judged by the investigator to be inappropriate for inclusion in the study
About this study
Official title: BLADDER (BPH, LUTS And Detrusor: Dual Effect Research) Study: A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study, Aimed at Characterising the Effect of Tamsulosin on Lower Urinary Tract Symptoms (LUTS) and Detrusor Motor Activity in Patients Affected by Benign Prostatic Hyperplasia (BPH) and Storage Urinary Symptoms
Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity in patients with LUTS suggestive of BPH and relevant storage symptoms
- Conditions
- Prostatic Hyperplasia
- Being tested
- Tamsulosin HCl controlled release capsules, Matching placebo capsule
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin HCl controlled release capsulesDrug
Matching placebo capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | Not described Receives: Drug: Tamsulosin HCl controlled release capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean number of micturitions per day
As reported in the Urinary Chart
Measured: Up to 12 weeks after first drug administration
Secondary outcomes (11)
Changes in mean number of urgency episodes per day
Measured: Up to 12 weeks after first drug administration
Changes in voided volume per micturition
Measured: Up to 12 weeks after first drug administration
Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores
Measured: Up to 12 weeks after first drug administration
Changes in Quality of Life in BPH patients with urinary symptoms (QUIBUS) Italian Score QUIBUS Symptom Score (QUISS) -11 on storage and voiding sub-scores
Measured: Up to 12 weeks after first drug administration
Changes in International Index of Erectile Function (IIEF)
Measured: Up to 12 weeks after first drug administration
Changes in Uroflowmetry
Measured: Up to 12 weeks after first drug administration
Changes in Qmax
Measured: Up to 12 weeks after first drug administration
Changes in volume at the first contraction
Measured: Up to 12 weeks after first drug administration
Number of unstable contractions
Measured: Up to 12 weeks after first drug administration
Maximum amplitude of unstable contractions
Measured: Up to 12 weeks after first drug administration
Number of patients with adverse events
Measured: Up to 12 weeks after first drug administration
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 2003
- Primary completionApr 2004
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 153 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
- NCT02245490
- Sponsor's protocol ID
- 527.30
- 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
- BLADDER (BPH, LUTS And Detrusor: Dual Effect Research) Study: A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study, Aimed at Characterising the Effect of Tamsulosin on Lower Urinary Tract Symptoms (LUTS) and Detrusor Motor Activity in Patients Affected by Benign Prostatic Hyperplasia (BPH) and Storage Urinary Symptoms
- ClinicalTrials.gov ID
- NCT02245490
- Acronym / sponsor ID
- 527.30
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Apr 2004 (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.
Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity in patients with LUTS suggestive of BPH and relevant storage symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: Tamsulosin HCl controlled release capsules |
| Placebo | Placebo comparator | Drug: Matching placebo capsule |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male outpatients aged 50-80 years
- LUTS suggestive of BPH
- Medical history: storage symptoms (frequency, urgency) for at least 6 months
- Urinary Chart:
- I-PSS ≥ 13 at randomisation (Visit 3)
Key exclusion criteria (38 listed)
- Patients with a known history or a diagnosis at the time of the screening visit (Visit 1) of the following conditions:
- Urological disturbances
- Cardiovascular diseases (if they occurred in the last 6 months)
- Neurological diseases (if their severity might compromise the correct performance of the trial)
- Hepatic or renal insufficiency (biochemistry values 15% outside normal lab ranges, being regarded as clinically relevant by the investigator)
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 HCl controlled release capsules | Drug | Tamsulosin |
| Matching placebo capsule | Drug | Placebo |
Primary outcome
Changes in mean number of micturitions per day
Time frame: Up to 12 weeks after first drug administration
As reported in the Urinary Chart
11 secondary outcomes
Changes in mean number of urgency episodes per day
Time frame: Up to 12 weeks after first drug administration
Changes in voided volume per micturition
Time frame: Up to 12 weeks after first drug administration
Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores
Time frame: Up to 12 weeks after first drug administration
Changes in Quality of Life in BPH patients with urinary symptoms (QUIBUS) Italian Score QUIBUS Symptom Score (QUISS) -11 on storage and voiding sub-scores
Time frame: Up to 12 weeks after first drug administration
Changes in International Index of Erectile Function (IIEF)
Time frame: Up to 12 weeks after first drug administration
Changes in Uroflowmetry
Time frame: Up to 12 weeks after first drug administration
Changes in Qmax
Time frame: Up to 12 weeks after first drug administration
Changes in volume at the first contraction
Time frame: Up to 12 weeks after first drug administration
Number of unstable contractions
Time frame: Up to 12 weeks after first drug administration
Maximum amplitude of unstable contractions
Time frame: Up to 12 weeks after first drug administration
Number of patients with adverse events
Time frame: Up to 12 weeks after first drug administration
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?
A Phase 4 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 10 inclusion and 38 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. 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?
Changes in mean number of micturitions per day (time frame: Up to 12 weeks after first drug administration). 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.