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Sponsored by: |
Spectrum Pharmaceuticals, Inc |
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Information provided by: | Spectrum Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00743184 |
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 |
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) |
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
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Drug: Placebo
Identical placebo is also provided and reconstituted using diluent containing 0.1% saline solution
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2: Experimental
15 mg Ozarelix + 15 mg Ozarelix
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Drug: ozarelix
One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.
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3: Experimental
30 mg Ozarelix + 15 mg Ozarelix
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Drug: ozarelix
One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (All must be answered yes):
Exclusion Criteria (all must be answered No):
Has the patient taken or is the patient currently taking any of the following:
Contact: Bela Denes, MD | (949) 743-9269 | |
Contact: Debra Robbins | (949) 743-9235 |
United States, California | |
California Professional Research | Recruiting |
Newport Beach, California, United States, 92660 | |
Contact: Sandi Bunting 949-644-7200 | |
Principal Investigator: Stephen Auerbach, MD |
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 |
BPH LUTS Lower urinary tract symptoms (LUTS) |
Hyperplasia Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
Pathologic Processes |