The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
12. oktober 2021 opdateret af: Spectrum Pharmaceuticals, Inc
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)
This study is to compare the efficacy and safety of ozarelix 15 mg given intramuscular (IM) 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with Benign Prostatic Hypertrophy (BPH) who are over 50 years of age.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is to compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from lower urinary tract symptoms (LUTS) secondary to Benign Prostatic Hypertrophy (BPH) following treatment with ozarelix. Ozarelix is compared to placebo and injections given 14 days apart. Patients are followed for 6 months and both safety and efficacy assessed at monthly visits. Additionally, the impact of treatment on erectile function, if any, as well as Prostate-Specific Antigen (PSA) and Testosterone levels will be monitored.
The screening period of 7 days. The duration of the study is 40 weeks, including a 28-day placebo run-in phase (eligible participants entered a placebo run-in phase in which placebo is administered twice over a 2 week period [Day -28 and Day -14] and participants are assessed to establish baseline values approximately 14 days following the second placebo injection), study drug is administered on Days 0 and 14 followed by 34 weeks of observation after the last dose of study drug.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
74
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85712
- Donald Gleason, MD
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California
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Laguna Hills, California, Forenede Stater, 92653
- Jay Young, MD
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Los Angeles, California, Forenede Stater, 90048
- Alexander Gershman, MD
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Newport Beach, California, Forenede Stater, 92660
- Stephen Auerbach, MD
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Tarzana, California, Forenede Stater, 91356
- Eugene Dula, MD
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Joel Kaufman, MD
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Florida
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Ocala, Florida, Forenede Stater, 34474
- Ira Klimberg, MD
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Idaho
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Meridian, Idaho, Forenede Stater, 83642
- Joseph Williams, MD
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46825
- Christopher Steidle, MD
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63136
- Steven Bigg, MD
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New York
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New York, New York, Forenede Stater, 10016
- Jed Kaminetsky, MD
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Texas
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San Antonio, Texas, Forenede Stater, 78229
- William Fitch, MD
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23454
- Gregg Eure, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- All of the following questions must be answered "Yes" at Visit 1 in order for the participant to participate in the study.
- Is the participant at least 50 years old?
- Does the participant have clinical signs and symptoms consistent with BPH?
- Does the participant have an IPSS 13 at screening (prior to placebo run in)?
- Does the participant have a peak urinary flow rate (Qmax) of 4-15 milliliter/second (mL/sec) established on a voided volume of at least 125 mL?
- Is the participant 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 participant to participate in the study.
- Does the participant have a history of prostate cancer or a serum PSA >10 nanograms 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 residual urine volume > 350 mL by ultrasound?
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Ozarelix
All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received ozarelix on Day 0 and Day 14.
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Ozarelix 15 mg will be administered IM on Day 0 and Day 14.
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Placebo komparator: Placebo
All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received placebo Day 0 and Day 14.
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Placebo will be administered IM on Day 0 and Day 14.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS)
Tidsramme: 12 weeks
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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.
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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International Prostate Symptom Score - Quality of Life (IPSS-QOL)
Tidsramme: 36 weeks
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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.
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36 weeks
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BPH Impact Index (BPHII)
Tidsramme: 36 weeks
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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).
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36 weeks
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Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
Tidsramme: 36 weeks
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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.
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36 weeks
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International Index of Erectile Function-15 (IIEF-15)
Tidsramme: 36 weeks
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International Index of Erectile Function Erectile Function Domain (IIEF-EF) will be used to assess the effect of ozarelix on erectile function in sexually active men.
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 IIEF-EF scores represent diminished erectile function.
Men with a score of ≥ 26 are interpreted as having normal erectile function.
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36 weeks
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Maximum Urinary Flow Rate (Qmax)
Tidsramme: 36 weeks
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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.
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36 weeks
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Number of Participants With Adverse Events
Tidsramme: 36 weeks
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36 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. januar 2007
Primær færdiggørelse (Faktiske)
27. februar 2008
Studieafslutning (Faktiske)
27. februar 2008
Datoer for studieregistrering
Først indsendt
24. januar 2007
Først indsendt, der opfyldte QC-kriterier
24. januar 2007
Først opslået (Skøn)
26. januar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. oktober 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. oktober 2021
Sidst verificeret
1. oktober 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SPI-153-06-1
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