Prostate HyperplasiaPhase 2NCT02244294
FLOMAX® Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia (BPH)
A Phase 2 study testing FLOMAX® capsules in people with Prostate Hyperplasia, run by Boehringer Ingelheim.
Trial summary
To establish whether the administration of FLOMAX® improves the outcome of a trial without catheter (TWOC) after an episode of acute urinary retention and to determine whether spontaneous voiding is maintained over the course of six months of active treatment Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- FLOMAX® capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Jun 2005
- Phase
- Phase 2
- 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
- Phase I
- Adult men, 45 years of age or older, diagnosed with acute urinary retention due to BPH
- Patients who have never taken alpha-blockers or discontinued taking alpha-blockers 72 hours or more prior to entrance into this study
- Patients that have been treated with an indwelling urethral catheter as treatment for acute urinary retention (AUR) due to BPH
- Patients must be judged by the investigator to be reliable and willing to comply with all tests and examinations stipulated in the protocol
- All patients must be willing to give meaningful, written, informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must also have sufficient understanding to communicate effectively with the investigator
- Phase II - Patients who voided spontaneously, at least 100 mL and a post-void residual volume of ≤ 300 mL, at Visit 2
Who cannot join
- Phase I
- Patients diagnosed with a symptomatic/active urinary tract infection (UTI) or an abnormal urine culture at baseline or 2 or more UTIs within the last six months. An abnormal urine culture was defined as:
- A bacterial colony count of greater than or equal to 100,000 CFU/mL or
- A bacterial colony count of greater than or equal to 100 CFU/mL of a known urinary pathogen in a symptomatic patient
- Patients that have a distended bladder volume greater than 1.5 liters (1500 ml) of retention as measured by initial catheter urine volume
- Patients with history of sexually transmitted disease within last two years
Show all 40Show fewer
- Patients with active genital herpes disease whose urinary function was impacted due to the disease
- Patients who have a history of mechanical outlet obstruction excluding BPH (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi)
- Patients with urethral stricture disease
- Patients with a history of bladder, prostate, or urethral surgery in the last three months
- Patients presenting with AUR who were not been seen within 5 days of urethral catheter placement
- Patients presenting with any of the following: active urinary stone disease, previous pelvic radiotherapy, perirectal inflammatory disorders or inflammatory bowel disease
- Participation in another drug study within 30 days of Visit 1
- Clinically relevant conditions which may interfere with the patient's ability to participate in the study including, but not limited to, the following: neurologic, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, hematologic or respiratory disease and clinically relevant laboratory abnormalities not mentioned above (e.g., hematuria) based upon the clinical judgment of the investigator
- Patients receiving cimetidine, ranitidine or warfarin within two weeks of study start date and who would potentially use such medications during the course of the trial
- Patients currently treated with finasteride (PROSCAR®) and who would not discontinue its use upon entrance into the study
- Patients with known hypersensitivity to FLOMAX® (tamsulosin hydrochloride) or other alpha-blockers
- Patients with a history of myocardial infarction within six months of baseline
- Patients with uncontrolled hypertension (systolic > 160 mmHg, diastolic > 100 mmHg) and patients with severe hypotension (systolic < 90 mmHg)
- Patients who have been using the following drugs, 72 hours prior to study start date, or who are unable to discontinue these drugs over the course of the study:
- Alpha-adrenergic medication
- Drugs with systemic anticholinergic activity including antihistamines. The following antihistamines are allowed: ALLEGRA®, CLARITIN® or ZYRTEX®
- Antispasmodics or muscle relaxants
- Parasympathomimetics, cholinomimetics or similar drug
- Patients that have poorly controlled diabetes mellitus who suffer from peripheral neuropathy or diabetic cystopathy
- Patients who suffer from neurological diseases affecting the bladder (i.e., multiple sclerosis, Parkinson's disease, stroke, and any bladder trauma that may be an exclusion criterion in the opinion of the investigator
- Patients with a neurological impairment or psychiatric disorder that prevents their comprehension of the informed consent and/or the ability to comply with the protocol
- Patients with a urine volume at the initial catheterization less than 300 mL
- Patients with a diagnosis of active cancer, except basal cell carcinoma, within 5 years or less
- Patients who had a transurethral resection of the prostate (TURP) within 5 years or less of study enrollment and irreversible urethral damage due to the procedure
- Phase II
- Patients with clinically, significant abnormal lab results including any baseline laboratory serum test with the following values:
- Hemoglobin < 11.0 g/dL
- Leukocytes < 3,000 per mm3
- Liver enzymes [aspartate aminotransferase (SGOT), alanine transaminase (SGPT) and alkaline phosphatase]: more than two times the upper limit of normal at baseline
- Serum creatinine more than two times the upper limit of normal at Visit 1
- Patients with clot retention, persistent gross hematuria (Visit 3 only), prostatitis, a symptomatic/active urinary tract infection (UTI) or an abnormal baseline urine culture
- An abnormal urine culture was defined as:
- A bacterial colony count of greater than or equal to 100,000 colony forming units (CFU)/mL or
- A bacterial colony count of greater than or equal to 100 CFU/mL of a kown urinary pathogen in a symptomatic patient
About this study
Official title: A Two Phase, Double-blinded, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia
To establish whether the administration of FLOMAX® improves the outcome of a trial without catheter (TWOC) after an episode of acute urinary retention and to determine whether spontaneous voiding is maintained over the course of six months of active treatment
- Conditions
- Prostate Hyperplasia
- Being tested
- FLOMAX® capsules, Placebo capsules
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOMAX® capsulesDrug
Also called Tamsulosin hydrochloride
Placebo capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| FLOMAX® | Experimental | Not described Receives: Drug: FLOMAX® capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful spontaneous voiding after urethral catheter removal
For Phase I of the trial
Measured: Up to 96 hours after start of treatment
Maintenance of successful spontaneous voiding
For Phase II of the trial
Measured: Up to 6 months after start of treatment
Secondary outcomes (5)
Change in voided urine volume
Measured: Up to 6 months after start of treatment
Determination of post-void residual urine volume
by ultrasound or bladder scan
Measured: Up to 6 months after start of treatment
Time to recurrence of AUR
For phase II of the trial
Measured: Up to 6 months after start of treatment
Clinically significant changes from baseline in vital signs
Measured: Pre-dose, up to 6 months after start of treatment
Number of patients with adverse events
Measured: Up to 6 months
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 startMar 2001
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 176 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
- NCT02244294
- Sponsor's protocol ID
- 527.26
- 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 Two Phase, Double-blinded, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02244294
- Acronym / sponsor ID
- 527.26
- Conditions
- Prostate Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Jun 2005 (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.
To establish whether the administration of FLOMAX® improves the outcome of a trial without catheter (TWOC) after an episode of acute urinary retention and to determine whether spontaneous voiding is maintained over the course of six months of active treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLOMAX® | Experimental | Drug: FLOMAX® capsules |
| Placebo | Placebo comparator | Drug: Placebo capsules |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Phase I
- Adult men, 45 years of age or older, diagnosed with acute urinary retention due to BPH
- Patients who have never taken alpha-blockers or discontinued taking alpha-blockers 72 hours or more prior to entrance into this study
- Patients that have been treated with an indwelling urethral catheter as treatment for acute urinary retention (AUR) due to BPH
- Patients must be judged by the investigator to be reliable and willing to comply with all tests and examinations stipulated in the protocol
Key exclusion criteria (40 listed)
- Phase I
- Patients diagnosed with a symptomatic/active urinary tract infection (UTI) or an abnormal urine culture at baseline or 2 or more UTIs within the last six months. An abnormal urine culture was defined as:
- Patients that have a distended bladder volume greater than 1.5 liters (1500 ml) of retention as measured by initial catheter urine volume
- Patients with history of sexually transmitted disease within last two years
- Patients with active genital herpes disease whose urinary function was impacted due to the disease
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 |
|---|---|---|
| FLOMAX® capsulesAlso: Tamsulosin hydrochloride | Drug | FLOMAX® |
| Placebo capsules | Drug | Placebo |
Primary outcome
Successful spontaneous voiding after urethral catheter removal
Time frame: Up to 96 hours after start of treatment
For Phase I of the trial
Maintenance of successful spontaneous voiding
Time frame: Up to 6 months after start of treatment
For Phase II of the trial
5 secondary outcomes
Change in voided urine volume
Time frame: Up to 6 months after start of treatment
Determination of post-void residual urine volume
Time frame: Up to 6 months after start of treatment
Time to recurrence of AUR
Time frame: Up to 6 months after start of treatment
Clinically significant changes from baseline in vital signs
Time frame: Pre-dose, up to 6 months after start of treatment
Number of patients with adverse events
Time frame: Up to 6 months
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 2 study testing FLOMAX® capsules in people with Prostate 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 40 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Successful spontaneous voiding after urethral catheter removal (time frame: Up to 96 hours after start of treatment). The study lists 2 primary outcomes in all. 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.