Status:
COMPLETED
Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Prostatitis
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chron...
Detailed Description
The two primary objectives of this study are: * To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naive CP/CPPS participants with respect to the primary...
Eligibility Criteria
Inclusion
- Participant has signed and dated the appropriate Informed Consent document.
- Participant is male.
- Participant is at least 18 years of age.
- Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.
- Symptoms bothersome enough to prompt a physician visit have been present for two years or less.
Exclusion
- Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).
- Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.
- Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
- Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.
- Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.
- Participant has uninvestigated, significant hematuria.
- Participant has undergone transurethral prostatectomy (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
- Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
- Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00103402
Start Date
February 1 2005
End Date
January 1 2008
Last Update
June 12 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
Northwestern U. Feinberg School of Medicine
Chicago, Illinois, United States, 60611
4
University of Maryland
Baltimore, Maryland, United States, 21201