- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244255
FLOMAX® Versus HYTRIN® in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia
September 18, 2014 updated by: Boehringer Ingelheim
An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-in Study of FLOMAX® Capsules, 0.4 mg Daily Versus HYTRIN® Capsules, 5 mg (With Titration) Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia
- To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the signs and symptoms of benign prostatic hyperplasia (BPH)
- To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the symptoms of benign prostatic hyperplasia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1993
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male patients (45 years of age or older) diagnosed with benign prostatic hyperplasia
- Patients with a total score on the AUA Symptom Index for BPH of at least 13 points at each of the three initial visits (Visits 1, 2 and 3)
- A baseline prostate specific antigen (PSA) of ≤ 4.0 ng/ml
- Patients who are able to give written informed consent before performing screening examinations or tests
- Patients being judged by the investigator to be reliable and able to follow protocol procedures (including the return visits schedule), and cooperate in the completion of tests related to safety and efficacy
Exclusion Criteria:
- Patients with a history of an allergy to alpha blockers, alpha/beta blockers or patients who have had a "first dose hypotensive episode" upon starting therapy with an alpha blocker
- Patients who are currently being treated or who, in the last 3 months, have been treated with finasteride
- Participated in an investigational drug study within 4 weeks prior to starting placebo phase
Patients taking medication in the following classes and unable to discontinue them at least two weeks before the study and for the duration of the study
- Alpha adrenergic blocking agents
- Alpha adrenergic agonists
- Drugs with anticholinergic activity (including antihistamines)
- Antispasmodics
- Parasympathomimetics and cholinomimetics
- Peripheral or central neurologic disease including, but not limited to, transient ischemic attacks, stroke, dementia, multiple sclerosis, spinal cord injury, recurrent episodes of dizziness, vertigo, or loss of consciousness, clinically evident diabetic neuropathy, brain and/or spinal cord tumors
- History of a pathological fall (unintentional change in body position) occurring under circumstances in which normal homeostatic mechanisms would ordinarily maintain stability, or syncope during the last year
- More than one episode of angina within the past 6 months
- Ambulation requiring assistance (i.e., canes, walkers, etc.)
- Documented myocardial infarction (by ECG) within the past 6 months or evidence of a myocardial infarction on ECG whose age cannot be determined
- New York Heart Association Class III or IV congestive heart failure
- Prosthetic heart valves, cardiac devices or prior history of endocarditis
- Clinically significant cardiac arrhythmias either diagnosed by ECG or recorded in the medical history, whether or not accompanied by symptoms (e.g., dizziness, presyncope, syncope, unsteadiness)
Infravesical obstruction by history due to:
- Vesical neck contracture
- Clinical suspicion of prostate carcinoma
- Mullerian duct cysts
- Urethral obstruction due to stricture, valves, sclerosis or urethral tumor
- Inflammatory or infectious conditions
- Detrusor-sphincter dyssynergia
- Prior transurethral resection of the prostate (TURP) or open prostatectomy
- History of instrumentation of the urinary tract (cytoscopy or catheterization) within 30 days prior to the start of the study
- Prior pelvic surgery for malignancy or bowel resection
- History or diagnosis of genitourinary malignancy
- History of an episode of acute urinary retention within three months prior to the start of the study. (Urinary retention is to be considered acute if the patient has to be sent to a hospital for catheterization)
- Patients with the current diagnosis of either bladder, ureter, or kidney stones
- Patients with a current diagnosis of suspected prostatitis
- Patients with a history of a neurogenic bladder
- Urinary tract infection (i.e., positive urine culture) yielding pathogenic bacteria > 10**5 colony forming units (CFU) per milliliter in a properly obtained clean voided urine specimen which has been properly cultured or a laboratory report of a urinary tract infection or signs/symptoms indicative of a urinary tract infection such as [increased WBC's in the urine (15-30 white blood cells (WBC)/high powered field), dysuria, costovertebral tenderness, and urinary frequency accompanied by fever] within four weeks of baseline (Visit 3)
- Evidence of significant renal dysfunction based upon a serum creatinine greater than two times the upper limit of normal levels established by the central laboratory used in this study
Laboratory tests during the screening phase:
- Hemoglobin: < 12.0 g/dL
- Leukocytes: < 3000/mm3
- Liver Enzymes: (serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), and alkaline phosphatase): more than two times the upper limit of normal levels established by the central laboratory used in the study
- Clinically relevant conditions which might interfere with the patient's ability to participate in the study including, but not limited to, the following: neurologic, gastrointestinal, cardiovascular including uncontrolled hypertension defined as a sitting diastolic blood pressure ≥ 95 mmHg with or without treatment, hepatic, renal, psychiatric, hematologic or respiratory disease, clinically relevant laboratory abnormalities based upon the investigator's judgment
- Hypertensive patients initially using HYTRIN® as a monotherapy for both hypertension and BPH
- Patients with cancer or diagnosis of cancer within five years of baseline
- Patients who have been receiving cimetidine, warfarin, or herbal medications specifically for treatment of any urological problems within four weeks prior to the baseline
Patients who show poor compliance in the initial placebo period by:
- not returning unused medication bottles for Visits 2 or 3
- having taken < 80% or > 120% of prescribed doses during any visit interval between Visit (1, 2 or 3)
- Postural symptoms during the initial placebo period, e.g., lightheadedness (on more than three occasions), fainting, blurring or loss of vision, profound weakness, or unsteadiness, with or without a change in blood pressure and/or pulse rate
- Patients with poorly controlled diabetes mellitus (urine positive for glucose (> 1+) on each of 2 urinalyses during the placebo evaluation period)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FLOMAX®
|
Other Names:
|
Active Comparator: HYTRIN®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in American Urological Association (AUA) symptom score index
Time Frame: Pre-dose, up to day 57 after start of treatment
|
Pre-dose, up to day 57 after start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in AUA bother score index
Time Frame: Pre-dose, up to 57days after start of treatment
|
Validated quality of life questionnaire for urinary problems containing:
|
Pre-dose, up to 57days after start of treatment
|
Changes in BPH impact index score
Time Frame: Pre-dose, up to 57 days after start of treatment
|
Pre-dose, up to 57 days after start of treatment
|
|
Global assessment by investigator on a 5-point scale
Time Frame: Day 5, up to day 57 after start of treatment
|
Day 5, up to day 57 after start of treatment
|
|
Number of patients with clinically relevant changes from baselinein laboratory values
Time Frame: Pre-dose, day 57 after start of treatment
|
Pre-dose, day 57 after start of treatment
|
|
Number of patients with clinically significant changes in vital signs
Time Frame: Pre-dose, up to 57 days after start of treatment
|
Pre-dose, up to 57 days after start of treatment
|
|
Number of patients with clinically relevant changes from baseline in ECG
Time Frame: Pre-dose, up to 57 days after start of treatment
|
Pre-dose, up to 57 days after start of treatment
|
|
Number of patients with adverse events
Time Frame: Up to day 57
|
Up to day 57
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1998
Primary Completion (Actual)
June 1, 2000
Study Registration Dates
First Submitted
September 18, 2014
First Submitted That Met QC Criteria
September 18, 2014
First Posted (Estimate)
September 19, 2014
Study Record Updates
Last Update Posted (Estimate)
September 19, 2014
Last Update Submitted That Met QC Criteria
September 18, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
Other Study ID Numbers
- 527.17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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