Prostatic HyperplasiaPhase 4NCT02244229
Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
A Phase 4 study testing Tamsulosin and Finasteride in people with Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general… Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Tamsulosin and Finasteride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Nov 2000
- 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 out-patients aged 50-80 years
- IPSS >= 13 at Visit 1
- Qmax: 4-15 ml/sec at Visit 2
- Residue urinary volume > 400 ml as evaluated by ultrasonography
- SPI >= 7 at Visit 2
- Prostate Specific Antigen (PSA) value < 3 ng/ml at Visit 1, or of 3-10 ng/ml provided that prostate cancer is ruled out on the basis of the usual diagnostic procedures performed at each Centre
- Written informed consent
Who cannot join
- Patients with known history or diagnosis at the time of the screening visit of the following conditions that could influence the end-points of the study:
- 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, urethral stricture, bladder or prostatic cancer, bladder stone, severe diverticulum of the bladder, symptomatic urinary tract infection during the last month, or recurrent urinary tract infections (more than 2 during the last year); hematuria of unknown origin; diseases that may affect micturition (e.g. diabetes mellitus)
- Cardiovascular diseases - The following cardiovascular diseases if occurred in the last 6 months:
- Myocardial infarction
- Unstable angina
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- Clinically significant ventricular arrhythmias
- Heart failure (NYHA classes III/IV)
- Orthostatic hypotension
- Cerebral stroke
- Neurological diseases
- such as senile dementia, multiple sclerosis, Parkinson's disease, psychiatric disturbances, if their severity could have prevented the correct performance of the trial
- Hepatic or renal insufficiency
- (Biochemistry values 15% outside normal laboratory ranges and regarded as clinically relevant by investigator)
- Clinically significant abnormalities in the results of hematologic and biochemical tests performed on blood samples drawn at the screening visit
- Patients who are taking or have been taking α-blockers for BPH or for hypertension or phytotherapy for BPH in the previous 6 weeks
- Patients who are taking or have been taking finasteride in the last 6 months
- Patients who require concomitant drugs which could influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. In particular: alpha-blockers and mixed alpha-beta blockers, alpha- agonists, anti-cholinergics
- Patient who are or have been taking part in a clinical study in the previous 3 months
- Patients who have hypersensitivity or allergic reactions to previously prescribed alpha-blocker(s) or to finasteride
- Patients judged by the investigator to be inappropriate for inclusion in the study
About this study
Official title: MICTUS (Multicentre Investigation to Characterise the Effect of Tamsulosin on Urinary Symptoms): A Multicentre, Double-blind, Randomised, Parallel Group Study, Aimed at Characterising the Effect of Tamsulosin, an Uroselective α1- Receptor Blocking Agent, on the Urological Symptoms and Their Impact on General Health Status and Quality of Life in Outpatients Affected by Symptomatic Benign Prostatic Hyperplasia: Comparison With Finasteride.
Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life
- Conditions
- Prostatic Hyperplasia
- Being tested
- Tamsulosin, Finasteride, Placebo
- 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
FinasterideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | Not described Receives: Drug: Tamsulosin; Drug: Placebo |
| Finasteride | Active comparator | Not described Receives: Drug: Finasteride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire
Measured: Baseline, after 26 weeks of treatment
Secondary outcomes (6)
Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire
Measured: up to 52 weeks
Change in International Prostatic Symptom Score (IPSS)
questionnaire for the self-evaluation of urinary symptoms
Measured: up to 52 weeks
Change in Qmax by means of free flow uroflowmetry
Measured: up to 52 weeks
Number of patients who withdrew due to inefficacy
Measured: up to 52 weeks
Number of patients with adverse events
Measured: up to 54 weeks
Number of patients with abnormal changes in laboratory parameters
Measured: up to 52 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 startApr 1998
- Primary completionNov 2000
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
- 403 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
- NCT02244229
- Sponsor's protocol ID
- 527.15
- 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
- MICTUS (Multicentre Investigation to Characterise the Effect of Tamsulosin on Urinary Symptoms): A Multicentre, Double-blind, Randomised, Parallel Group Study, Aimed at Characterising the Effect of Tamsulosin, an Uroselective α1- Receptor Blocking Agent, on the Urological Symptoms and Their Impact on General Health Status and Quality of Life in Outpatients Affected by Symptomatic Benign Prostatic Hyperplasia: Comparison With Finasteride.
- ClinicalTrials.gov ID
- NCT02244229
- Acronym / sponsor ID
- 527.15
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Nov 2000 (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 therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life
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, Drug: Placebo |
| Finasteride | Active comparator | Drug: Finasteride, Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male out-patients aged 50-80 years
- IPSS >= 13 at Visit 1
- Qmax: 4-15 ml/sec at Visit 2
- Residue urinary volume > 400 ml as evaluated by ultrasonography
- SPI >= 7 at Visit 2
Key exclusion criteria (21 listed)
- Patients with known history or diagnosis at the time of the screening visit of the following conditions that could influence the end-points of the study:
- Urological disturbances
- Cardiovascular diseases - The following cardiovascular diseases if occurred in the last 6 months:
- Neurological diseases
- Hepatic or renal insufficiency
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 | Drug | Tamsulosin |
| Finasteride | Drug | Finasteride |
| Placebo | Drug | Finasteride, Tamsulosin |
Primary outcome
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire
Time frame: Baseline, after 26 weeks of treatment
6 secondary outcomes
Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire
Time frame: up to 52 weeks
Change in International Prostatic Symptom Score (IPSS)
Time frame: up to 52 weeks
Change in Qmax by means of free flow uroflowmetry
Time frame: up to 52 weeks
Number of patients who withdrew due to inefficacy
Time frame: up to 52 weeks
Number of patients with adverse events
Time frame: up to 54 weeks
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 52 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?
A Phase 4 study testing Tamsulosin and Finasteride in people with 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 7 inclusion and 21 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.
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?
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire (time frame: Baseline, after 26 weeks of treatment). 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.