Trial record 7 of 10 for:
klimberg and phase II
The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
This study has been completed.
Sponsor:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00427219
First received: January 24, 2007
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
This study will compare the efficacy and safety of ozarelix 15 mg. given IM 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with BPH who are over 50 years of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Prostatic Hypertrophy |
Drug: Ozarelix/Placebo Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A 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 Hypertrophy (BPH) |
Resource links provided by NLM:
Further study details as provided by Spectrum Pharmaceuticals, Inc:
Primary Outcome Measures:
- Improvement in IPSS compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- IPSS subscores; IPSS QOL ;BII;LUTS GAQ;Qmax;To examine the effect of ozarelix on erectile function in sexually active men;To assess the safety and tolerability of ozarelix [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 76 |
| Study Start Date: | January 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo run-in phase
Eligible patients entered a placebo run-in phase in which placebo was administered twice over a 2 week period (Day -28 and Day -14) and patients were assessed to establish baseline values approximately 14 days following the second placebo injection
|
Drug: Placebo
Eligible patients entered a placebo run-in phase in which placebo was administered twice over a 2 week period (Day -28 and Day -14) and patients were assessed to establish baseline values approximately 14 days following the second placebo injection
|
|
Experimental: Ozarelix/Placebo
All patients completing the placebo run in period were randomized to enter the treatment phase of the study and received either placebo or ozarelix on Day 0 and Day 14
|
Drug: Ozarelix/Placebo
Ozarelix 15 mg or placebo will be administered IM on Day 0 and Day 14
|
Detailed Description:
This study will compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from LUTS secondary to BPH following treatment with ozarelix. Ozarelix will be compared to placebo and injections will be given 14 days apart. Patients will be followed for 6 months and both safety and efficacy will be assessed at monthly visits.Additionally the impact of treatment on erectile function, if any, as well as PSA and Testosterone levels will be monitored.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All of the following questions must be answered "Yes" at Visit 1 in order for the patient to participate in the study.
- Is the patient at least 50 years old?
- Does the patient have clinical signs and symptoms consistent with BPH?
- Does the patient have an IPSS ³13 at screening (prior to placebo run in)?
- Does the patient have a peak urinary flow rate (Qmax) of 4-15 mL/sec established on a voided volume of at least 125 mL?
- Is the patient willing to agree not to use any other approved or experimental pharmacologic BPH treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study?
Exclusion Criteria: All of the following questions must be answered "No" at Visit 1 in order for the patient to participate in the study.
- 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 residual urine volume > 350 mL by ultrasound?
- Has the patient taken or is currently taking any of the following:
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427219
Locations
| United States, Arizona | |
| Donald Gleason, MD | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Jay Young, MD | |
| Laguna Hills, California, United States, 92653 | |
| Alexander Gershman, MD | |
| Los Angeles, California, United States, 90048 | |
| Stephen Auerbach, MD | |
| Newport Beach, California, United States, 92660 | |
| Eugene Dula, MD | |
| Tarzana, California, United States, 91356 | |
| United States, Colorado | |
| Joel Kaufman, MD | |
| Aurora, Colorado, United States, 80012 | |
| United States, Florida | |
| Ira Klimberg, MD | |
| Ocala, Florida, United States, 34474 | |
| United States, Idaho | |
| Joseph Williams, MD | |
| Meridian, Idaho, United States, 83642 | |
| United States, Indiana | |
| Christopher Steidle, MD | |
| Ft. Wayne, Indiana, United States, 46825 | |
| United States, Missouri | |
| Steven Bigg, MD | |
| St. Louis, Missouri, United States, 63136 | |
| United States, New York | |
| Jed Kaminetsky, MD | |
| New York, New York, United States, 10016 | |
| United States, Texas | |
| William Fitch, MD | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Gregg Eure, MD | |
| Virginia Beach, Virginia, United States, 23454 | |
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
More Information
No publications provided
| Responsible Party: | Spectrum Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00427219 History of Changes |
| Other Study ID Numbers: | SPI-153-06-1 |
| Study First Received: | January 24, 2007 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Spectrum Pharmaceuticals, Inc:
|
Benign Prostatic Hyperplasia Prostatic Adenoma, Benign Prostatic Hypertrophy, Benign |
Enlarged Prostate Prostatism Adenoma, Prostatic |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hypertrophy Prostatic Diseases Genital Diseases, Male Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013