Back to resultsStudy to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
Primary Purpose
Prostatic Hyperplasia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tamsulosin
Finasteride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tamsulosin
Finasteride
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire
Secondary Outcome Measures
Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire
Change in International Prostatic Symptom Score (IPSS)
questionnaire for the self-evaluation of urinary symptoms
Change in Qmax by means of free flow uroflowmetry
Number of patients who withdrew due to inefficacy
Number of patients with adverse events
Number of patients with abnormal changes in laboratory parameters
Full Information
NCT ID
NCT02244229
First Posted
September 18, 2014
Last Updated
September 18, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02244229
Brief Title
Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
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 Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief 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 health and quality of life
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin
Arm Type
Experimental
Arm Title
Finasteride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Type
Drug
Intervention Name(s)
Finasteride
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire
Time Frame
Baseline, after 26 weeks of treatment
Secondary Outcome Measure Information:
Title
Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire
Time Frame
up to 52 weeks
Title
Change in International Prostatic Symptom Score (IPSS)
Description
questionnaire for the self-evaluation of urinary symptoms
Time Frame
up to 52 weeks
Title
Change in Qmax by means of free flow uroflowmetry
Time Frame
up to 52 weeks
Title
Number of patients who withdrew due to inefficacy
Time Frame
up to 52 weeks
Title
Number of patients with adverse events
Time Frame
up to 54 weeks
Title
Number of patients with abnormal changes in laboratory parameters
Time Frame
up to 52 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
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Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
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