Trial of the Safety and Efficacy of Ozarelix in Patients With Benign Prostatic Hyperplasia (BPH) - Full Text View

Sponsored by:	Spectrum Pharmaceuticals, Inc
Information provided by:	Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00743184

Purpose

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 benign prostatic hyperplasia (BPH) in men as assessed by the International Prostate Symptom Score (IPSS) at Week 14.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia (BPH)	Drug: ozarelix Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Ozarelix, in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:

Change from baseline IPSS score [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline IPSS (including subscores) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Change from baseline maximum urine flow (Q max) [ Time Frame: Weeks 14 and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	860
Study Start Date:	September 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo + Placebo	Drug: Placebo Identical placebo is also provided and reconstituted using diluent containing 0.1% saline solution
2: Experimental 15 mg Ozarelix + 15 mg Ozarelix	Drug: ozarelix One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.
3: Experimental 30 mg Ozarelix + 15 mg Ozarelix	Drug: ozarelix One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.

Detailed Description:

This is a multi-center, randomized, double-blind, placebo-controlled study.

Patients who meet the entry IPSS inclusion criteria at Week 0 will be randomized and enroll in the double-blind treatment period. Patients will be randomized to one of three treatment arms and will receive two 6-month courses of study drug administered on Days 0 and 14 of each 6-month course. Treatment arms include: ozarelix 30mg + 15mg, ozarelix 15mg + 15mg or placebo + placebo. Safety and efficacy assessments will be performed at defined intervals throughout the study. At Week 52 all patients on study will be eligible to receive ozarelix for two additional courses in the open-label treatment period.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (All must be answered yes):

Has the patient given written informed consent?
Is the patient at least 50 years old?
Is the patient diagnosed with BPH and has he had clinical signs and symptoms of BPH for ≥ 6 months?
Does the patient have an IPSS ≥ 13?
Does the patient 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 patient have an IPSS QoL score of ≥ 3?
Does the patient have a PSA > 0.8 ng/mL?
For patients 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 patient 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 patient willing to restrict use of 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 patient have an IPSS ≥ 13?
Does the patient have an IPSS QoL score of ≥ 3?
Does the patient have a post-void residual ≤ 350cc?

Exclusion Criteria (all must be answered No):

Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL?
Has the patient had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy?
Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL?
Does the patient have a post void residual urine volume ≥ 350 mL by ultrasound?
Has the patient taken or is the patient currently taking any of the following:
1. Estrogens, phytoestrogens, androgens, antiandrogens or 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,
2. 5 α-reductase inhibitors within the past 4 months (e.g. finasteride[Proscar®, Propecia®], dutasteride [Avodart®]) or,
3. Alpha blockers or anti-cholinergic preparations within the past 6 weeks (e.g. doxazosin [Cardura®], terazosin [Hytrin®], tamsulosin [Flomax®], alfuzosin [Uroxatrol®], oxybutinin [Ditropan®], tolteredine [Detrol-LA®], amytriptyline [Elavil®, Limbitrol®]) or,
4. Class 1A (e.g. quinidine, procainamide, disopyramide) or Class III Anti-arrhythmic (e.g.sotalol [Betapace®], amiodarone [Cordarone®])
Does the patient have or has the patient ever had a diagnosis of acute or chronic prostatitis or chronic pelvic pain syndrome?
Has the patient had a urinary tract infection or instrumentation (e.g catheterization, cystoscopy, prostate biopsy) within the past 4 weeks?
Does the patient have a history of urethral stricture, bladder stones, obstructing median lobe or neurogenic bladder dysfunction?
Does the patient have microscopic hematuria greater than trace by dipstick urine at Visit 1?
Did the patient have a positive drug screening result?
Does the patient have a history of urinary retention?
Does the patient have any serious medical condition (e.g., CHF, poorly controlled diabetes (HgbA1c > 9), psychiatric disorder, drug or alcohol abuse) that might interfere with his ability to comply with or complete the protocol?
Is the patient's QTc interval on the screening ECG > 450ms, or does he have a family history of long QT syndrome?
Does the patient 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 patient ever received ozarelix, cetrorelix, tevarelix or degarelix?
Has the patient 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 patient participated in any other clinical research study or study of an investigational drug in the past 90 days?

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743184

Contacts

Contact: Bela Denes, MD	(949) 743-9269
Contact: Debra Robbins	(949) 743-9235

Locations

United States, California
California Professional Research	Recruiting
Newport Beach, California, United States, 92660
Contact: Sandi Bunting 949-644-7200
Principal Investigator: Stephen Auerbach, MD

Sponsors and Collaborators

Spectrum Pharmaceuticals, Inc

More Information

Responsible Party:	Spectrum Pharmaceuticals, Inc ( Bela Denes, MD )
Study ID Numbers:	SPI-153-08-1
Study First Received:	August 26, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00743184
Health Authority:	United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:

BPH
LUTS
Lower urinary tract symptoms (LUTS)

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on February 11, 2009