Benign Prostatic Hyperplasia (BPH)Phase 2NCT00743184
Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH)
A Phase 2 study testing ozarelix in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS), run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- ozarelix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2008to 20 Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?
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- 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?
Who cannot join
- 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,
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- 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?
Trial locations and contacts
1 site in 1 country.
United States1 site
California Professional Research
Newport Beach, California, 92660
About this 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)
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.
Read the 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 treatment period. Participants 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 participants on study will be eligible to receive ozarelix for two additional courses in the open-label treatment period.
- Being tested
- ozarelix, Placebo
- Keywords
- BPH, LUTS, Lower urinary tract symptoms (LUTS)
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozarelixDrug
One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.
PlaceboDrug
Identical placebo is also provided and reconstituted using diluent containing 0.1% saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Placebo | Placebo comparator | Participants will receive Placebo + Placebo on Days 0 and 14 of each 6-month course. Receives: 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. Receives: 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. Receives: Drug: ozarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 14
Secondary outcomes (7)
Change From Baseline IPSS (Including Sub-scores) at Week 52
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). 1) Voiding- The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). 2) Storage- The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). Voiding and Storage: the lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). Voiding and Storage: each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. And 3) QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible).
Measured: Week 52
Change From Baseline Benign Prostatic Hyperplasia Impact Index (BPHII) Score at Week 14 and Week 52
BPH Impact Index (BII) is used to assess the impact of BPH on various aspects of health. This 4 question self administered index uses a scoring range from 0 (best) to 13 (worst).
Measured: Weeks 14 and 52
Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) Response at Week 52
The self administered LUTS GAQ is a "yes" or "no" response to a question asking whether overall improvement in LUTS will be observed during the treatment period.
Measured: Week 52
Change From Baseline Maximum Urine Flow (Qmax) at Week 14 and Week 52
Qmax was measured by free flow uroflowmetry. Qmax is defined as the peak urine flow rate (measured in milliliter (mL)/second using a standard calibrated flowmeter). For a Qmax to be considered valid, the voided volume had to be at least 125 mL. The uroflowmeter is to be calibrated weekly.
Measured: Week 14 and Week 52
Change From Baseline International Index of Erectile Function-15 (IIEF-EF) Score at Week 14 and Week 52
IIEF-EF is defined as the sum of the scores for Questions 1-5 and 15 of the IIEF questionnaire. This recall instrument is self-administered by the participant. Individual questions are graded from 1 to 5 with a maximum total score of 30. Lower IIEFEF scores represent diminished erectile function. Men with a score of ≥ 26 are interpreted as having normal erectile function.
Measured: Week 14 and Week 52
Change From Baseline International Prostate Symptom Score - Quality of Life (IPSS-QOL) at Week 14 and Week 52
IPSS QOL is a disease-specific quality of life question, referred to as IPSS Question 8. Participants with an IPSS QOL of <3 at screening will be excluded from this study. The rating is as follows: 0=delighted, 1=pleased, 2=mostly satisfied, 3=mixed, 4=mostly dissatisfied, 5=unhappy, 6=terrible.
Measured: Week 14 and Week 52
Number of Participants With Treatment-Emergent Adverse Events
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study start4 Dec 2008
- Primary completion20 Jan 2010
- Study completion20 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743184
- Sponsor's protocol ID
- SPI-153-08-1
- Status last verified
- Nov 2021
- First submitted
- 26 Aug 2008
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00743184
- Acronym / sponsor ID
- SPI-153-08-1
- Keywords
- BPH, LUTS, Lower urinary tract symptoms (LUTS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2008 (actual)
- Primary completion
- 20 Jan 2010 (actual)
- Study completion
- 20 Jan 2010 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 treatment period. Participants 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 participants on study will be eligible to receive ozarelix for two additional courses in the open-label treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo + Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Placebo + Placebo on Days 0 and 14 of each 6-month course. |
| 15 mg Ozarelix + 15 mg Ozarelix | Experimental | Drug: ozarelixParticipants will receive 15 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course. |
| 30 mg Ozarelix + 15 mg Ozarelix | Experimental | Drug: ozarelixParticipants will receive 30 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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?
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozarelixOne single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent. | Drug | 15 mg Ozarelix + 15 mg Ozarelix, 30 mg Ozarelix + 15 mg Ozarelix |
| PlaceboIdentical placebo is also provided and reconstituted using diluent containing 0.1% saline solution. | Drug | Placebo + Placebo |
Primary outcome
Change From Baseline International Prostate Symptom Score (IPSS) Score at Week 14
Time frame: 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.
7 secondary outcomes
Change From Baseline IPSS (Including Sub-scores) at Week 52
Time frame: Week 52
Change From Baseline Benign Prostatic Hyperplasia Impact Index (BPHII) Score at Week 14 and Week 52
Time frame: Weeks 14 and 52
Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) Response at Week 52
Time frame: Week 52
Change From Baseline Maximum Urine Flow (Qmax) at Week 14 and Week 52
Time frame: Week 14 and Week 52
Change From Baseline International Index of Erectile Function-15 (IIEF-EF) Score at Week 14 and Week 52
Time frame: Week 14 and Week 52
Change From Baseline International Prostate Symptom Score - Quality of Life (IPSS-QOL) at Week 14 and Week 52
Time frame: Week 14 and Week 52
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Up to 104 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ozarelix in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS), run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline International Prostate Symptom Score (IPSS) Score at Week 14 (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.