Status:
TERMINATED
Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)
Eligibility:
MALE
50+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms (LUTS) secondary to...
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study. Participants who meet the entry IPSS inclusion criteria at Week 0 will be randomized and enroll in the double-blind treatme...
Eligibility Criteria
Inclusion
- Inclusion Criteria (All must be answered yes):
- Has the participant given written informed consent?
- Is the participant at least 50 years old?
- Is the participant diagnosed with BPH and has he had clinical signs and symptoms of BPH for ≥ 6 months?
- Does the participant have an IPSS ≥ 13?
- Does the participant have a peak urinary flow rate (Qmax) of 4-15 mL/sec (utilizing the 2-second rule) established on a voided volume of at least 125 mL?
- Does the participant have an IPSS Quality of life (QoL) score of ≥ 3?
- Does the participant have a PSA \> 0.8 ng/mL?
- For participant with a PSA between 4 and 10 ng/mL or suspicion of prostate cancer, has the patient had a diagnostic evaluation (e.g., biopsy, PSA, velocity, etc.) that reasonably excludes the diagnosis of prostate cancer?
- Is the participant willing to agree not to use any other approved or experimental pharmacologic BPH treatments including but not limited to alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study?
- Is the participant willing to restrict use of Phosphodiesterase 5 (PDE 5) inhibitors exclusively to the use of Viagra, one dose per week only and with no dosing in the 5 days immediately preceding scheduled study visit?
- Is the patient willing and able to abide by the protocol?
- Does the participant have an IPSS ≥ 13?
- Does the participant have an IPSS QoL score of ≥ 3?
- Does the participant have a post-void residual ≤ 350cc?
- Exclusion Criteria (all must be answered No):
- Does the participant have a history of prostate cancer or a serum prostate specific antigen (PSA) \>10 nanogram per milliliter (ng/mL)?
- Has the participant had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy?
- Does the participant have a prevoid total bladder volume assessed by ultrasound \> 550 mL?
- Does the participant have a post void residual urine volume ≥ 350 mL by ultrasound?
- Has the participant taken or is the patient currently taking any of the following:
- Estrogens, phytoestrogens, androgens, antiandrogens or luteinizing hormone-releasing hormone (LHRH) agonists within the past 4 months (e.g. testosterone gel \[Androgel ®1%, Testim ® 1%\], testosterone buccal \[Striant®\], oxymetholone \[Anadrol®-50\], oxandrolone \[Oxandrin®\], esterified estrogen and methyltestosterone \[Estratest®\]), bicalutamide \[Casodex®\], nilutamide \[Nilandron®\], flutamide \[Eulexin®\], leuprolide acetate \[Lupron®, Eligard®, Viadur®\], goserelin acetate \[Zoladex®\] or,
- 5 α-reductase inhibitors within the past 4 months (e.g. finasteride\[Proscar®, Propecia®\], dutasteride \[Avodart®\]) or,
- Alpha blockers or anti-cholinergic preparations within the past 6 weeks (e.g. doxazosin \[Cardura®\], terazosin \[Hytrin®\], tamsulosin \[Flomax®\], alfuzosin \[Uroxatrol®\], oxybutynin \[Ditropan®\], tolterodine \[Detrol-LA®\], amitriptyline \[Elavil®, Limbitrol®\]) or,
- Class 1A (e.g. quinidine, procainamide, disopyramide) or Class III Anti-arrhythmic (e.g.sotalol \[Betapace®\], amiodarone \[Cordarone®\])
- Does the participant have or has the patient ever had a diagnosis of acute or chronic prostatitis or chronic pelvic pain syndrome?
- Has the participant had a urinary tract infection or instrumentation (e.g catheterization, cystoscopy, prostate biopsy) within the past 4 weeks?
- Does the participant have a history of urethral stricture, bladder stones, obstructing median lobe or neurogenic bladder dysfunction?
- Does the participant have microscopic hematuria greater than trace by dipstick urine at Visit 1?
- Did the participant have a positive drug screening result?
- Does the participant have a history of urinary retention?
- Does the participant have any serious medical condition (e.g., Congestive heart failure \[CHF\], poorly controlled diabetes (Hemoglobin A1C \[HgbA1c\] \> 9), psychiatric disorder, drug or alcohol abuse) that might interfere with his ability to comply with or complete the protocol?
- Is the participants corrected QT interval (QTc) interval on the screening electrocardiogram (ECG) \> 450ms, or does he have a family history of long QT syndrome?
- Does the participant anticipate or plan to have an elective surgery or surgical procedure requiring general, spinal or epidural anesthesia during the course of the double-blind treatment portion of the study(within the next 12 months)?
- Has the participant ever received ozarelix, cetrorelix, teverelix or degarelix?
- Has the participant participated in any other study of an investigational drug or treatment for the signs and symptoms LUTS or BPH in the past 12 months?
- Has the participant participated in any other clinical research study or study of an investigational drug in the past 90 days?
Exclusion
Key Trial Info
Start Date :
December 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00743184
Start Date
December 4 2008
End Date
January 20 2010
Last Update
November 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
California Professional Research
Newport Beach, California, United States, 92660