Prostatic HyperplasiaPhase 4NCT02244242
Study to Evaluate the Symptomatic Relief Effects of FLOMAX® in Patients With Signs and Symptoms of Benign Prostatic Hyperplasia
A Phase 4 study testing Tamsulosin hydrochloride in people with Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the symptomatic relief afforded by tamsulosin hydrochloride capsules in patients with signs and symptoms of benign prostatic hyperplasia (BPH). Additionally to provide primary care physicians experience with the use of tamsulosin hydrochloride capsules 0.4 mg daily for the treatment of BPH Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Tamsulosin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to Aug 1999
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients (45 years of age or older) diagnosed with BPH who scores at least 13 points on the AUA Symptom Score Index at baseline
- Patients who have a baseline Prostate specific antigen (PSA) of >= 4.0 ng/ml
- Patients who provide written informed consent prior to participation in the study in accordance with regulatory requirements
- Patients who have been judged by the investigator to be reliable and who have agreed to cooperate with all tests and examinations stipulated in the protocol
Who cannot join
- Patients who have previously been diagnosed with prostate cancer
- Patients who have an abnormal Digital rectal examination (DRE) of the prostate gland at baseline other than enlargement (i.e., patients with suspicious areas or nodularity of the gland which may indicate possible prostatic carcinoma are to be excluded)
- Patients who have had previous invasive or non-invasive surgical treatment of the prostate gland
- Patients who have had an episode of acute urinary retention within four weeks of the screening visit
- Patients who have a history or evidence of urethral stricture
- Patients who have had pelvic radiotherapy
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- Patients who have a history of chronic prostatitis
- Patients who have a history of neurogenic bladder
- Patients who have had a urinary tract infection (i.e. positive urine culture yielding pathogenic bacteria >= 10**5 colony forming units per ml or a laboratory report of a urinary tract infection) or symptoms/signs indicative of a urinary tract infection such as: increased white blood cells (WBCs) in the urine (15-30 WBC/high powered field [hpf], dysuria, costovertebral tenderness and urinary frequency accompanied by fever within four weeks of baseline
- Patients who have 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
- Patients who have baseline clinical laboratory test results that indicate the following values:
- Hemoglobin: < 12.0 g/dl
- Leukocytes: < 3000 mm³
- Liver enzymes: Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) and alkaline phosphatase): More than two times the upper limit of normal levels established by the central laboratory used in the study
- Patients who have postural symptoms (e.g. lightheadedness, dizziness and fainting occurring with or without a change in Blood Pressure (BP) and/or Heart Rate (HR) within four weeks of baseline
- Patients who have participated in another drug study within four weeks of baseline
- Patients who have 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 BP >= 95 mmHg with or without treatment), hepatic, renal, psychiatric, hematologic or respiratory disease or clinically relevant laboratory abnormalities based upon the investigator's judgment
- Patients who have had cancer or a diagnosis of cancer within five years of baseline
- Patients who have received cimetidine, warfarin or herbal medication specifically for treatment of any urological problems within four weeks prior or baseline
- Patients who have known allergy to study medication
- Patients who are currently receiving finasteride or who have been treated with finasteride within three months prior to baseline
- Patients who have documented myocardial infarction (by ECG) within the past 6 months or evidence of a myocardial infarction on an ECG where the date could not be determined
- Patients who are classified as New York Heart Association (NYHA) Class III or IV congestive heart failure
- Patients who have prosthetic heart valves, cardiac devices or history of endocarditis
- Patient who have clinically significant cardiac arrhythmias as diagnosed by ECG whether or not accompanied by symptoms (e.g., dizziness, presyncope, syncope, unsteadiness)
- Patients who have received the following drugs within two weeks prior to baseline and who are unable to discontinue these drugs for the remainder of the study:
- Alpha-adrenergic blocking agents
- Alpha-adrenergic agonists
- Drugs with anticholinergic activity including antihistamines
- Antispasmodics
- Parasympathomimetics and cholinomimetics
About this study
Official title: A Forty-Five Day, Open-label Study of the Symptomatic Relief Effects of FLOMAX® Capsules 0.4 mg Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia
Study to evaluate the symptomatic relief afforded by tamsulosin hydrochloride capsules in patients with signs and symptoms of benign prostatic hyperplasia (BPH). Additionally to provide primary care physicians experience with the use of tamsulosin hydrochloride capsules 0.4 mg daily for the treatment of BPH
- Conditions
- Prostatic Hyperplasia
- Being tested
- Tamsulosin hydrochloride
- 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 hydrochlorideDrug
Also called Flomax®
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin hydrochloride | Experimental | modified release capsules Receives: Drug: Tamsulosin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Urological Association (AUA) Symptom Score Index by means of a patient self-assessment questionnaire
Measured: up to 45 days
Secondary outcomes (4)
Change of AUA Bother Score Index by means of a patient self-assessment questionnaire
Measured: up to 45 days
Change in BPH Impact Index by means of a patient self-assessment questionnaire
Measured: up to 45 days
Global Assessment of investigator on 5-point scale
Measured: at 4, 8 and 45 days
Number of patients with adverse events
Measured: up to 59 days
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 startJul 1998
- Primary completionAug 1999
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 493 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
- NCT02244242
- Sponsor's protocol ID
- 527.16
- 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
- A Forty-Five Day, Open-label Study of the Symptomatic Relief Effects of FLOMAX® Capsules 0.4 mg Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02244242
- Acronym / sponsor ID
- 527.16
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Primary completion
- Aug 1999 (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 symptomatic relief afforded by tamsulosin hydrochloride capsules in patients with signs and symptoms of benign prostatic hyperplasia (BPH). Additionally to provide primary care physicians experience with the use of tamsulosin hydrochloride capsules 0.4 mg daily for the treatment of BPH
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin hydrochloride | Experimental | Drug: Tamsulosin hydrochloridemodified release capsules |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients (45 years of age or older) diagnosed with BPH who scores at least 13 points on the AUA Symptom Score Index at baseline
- Patients who have a baseline Prostate specific antigen (PSA) of >= 4.0 ng/ml
- Patients who provide written informed consent prior to participation in the study in accordance with regulatory requirements
- Patients who have been judged by the investigator to be reliable and who have agreed to cooperate with all tests and examinations stipulated in the protocol
Key exclusion criteria (32 listed)
- Patients who have previously been diagnosed with prostate cancer
- Patients who have an abnormal Digital rectal examination (DRE) of the prostate gland at baseline other than enlargement (i.e., patients with suspicious areas or nodularity of the gland which may indicate possible prostatic carcinoma are to be excluded)
- Patients who have had previous invasive or non-invasive surgical treatment of the prostate gland
- Patients who have had an episode of acute urinary retention within four weeks of the screening visit
- Patients who have a history or evidence of urethral stricture
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 hydrochlorideAlso: Flomax® | Drug | Tamsulosin hydrochloride |
Primary outcome
Change in American Urological Association (AUA) Symptom Score Index by means of a patient self-assessment questionnaire
Time frame: up to 45 days
4 secondary outcomes
Change of AUA Bother Score Index by means of a patient self-assessment questionnaire
Time frame: up to 45 days
Change in BPH Impact Index by means of a patient self-assessment questionnaire
Time frame: up to 45 days
Global Assessment of investigator on 5-point scale
Time frame: at 4, 8 and 45 days
Number of patients with adverse events
Time frame: up to 59 days
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 hydrochloride 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 4 inclusion and 32 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 in American Urological Association (AUA) Symptom Score Index by means of a patient self-assessment questionnaire (time frame: up to 45 days). 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.