Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH)

NCT00743184 | Terminated Phase 2

• 1 other identifier: SPI-153-08-1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS)

Keywords

BPH; LUTS; Lower urinary tract symptoms (LUTS)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline International Prostate Symptom Score (IPSS) Score at Week 14

  IPSS is a validated self-administered index for grading benign prostatic hyperplasia (BPH)-related signs and symptoms. It consists of a set of seven questions. A total score of 1-7 indicates mild disease, 8-19 moderate disease and 20-35 severe disease.

  Week 14

Secondary Outcomes (7)

• Change From Baseline IPSS (Including Sub-scores) at Week 52

  Week 52

• Change From Baseline Benign Prostatic Hyperplasia Impact Index (BPHII) Score at Week 14 and Week 52

  Weeks 14 and 52

• Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) Response at Week 52

  Week 52

• Change From Baseline Maximum Urine Flow (Qmax) at Week 14 and Week 52

  Week 14 and Week 52

• Change From Baseline International Index of Erectile Function-15 (IIEF-EF) Score at Week 14 and Week 52

  Week 14 and Week 52

Study Arms (3)

Placebo + Placebo

PLACEBO COMPARATOR

Participants will receive Placebo + Placebo on Days 0 and 14 of each 6-month course.

Drug: Placebo

15 mg Ozarelix + 15 mg Ozarelix

EXPERIMENTAL

Participants will receive 15 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course.

Drug: ozarelix

30 mg Ozarelix + 15 mg Ozarelix

EXPERIMENTAL

Participants will receive 30 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course.

Drug: ozarelix

Interventions

ozarelix DRUG

One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.

15 mg Ozarelix + 15 mg Ozarelix; 30 mg Ozarelix + 15 mg Ozarelix

Placebo DRUG

Identical placebo is also provided and reconstituted using diluent containing 0.1% saline solution.

Placebo + Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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,
• 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?

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

California Professional Research

Newport Beach, California, 92660, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

ozarelix

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: December 4, 2008
• Primary Completion: January 20, 2010
• Study Completion: January 20, 2010
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

US (1)