The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
12. oktober 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
74
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Tucson, Arizona, Forente stater, 85712
- Donald Gleason, MD
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California
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Laguna Hills, California, Forente stater, 92653
- Jay Young, MD
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Los Angeles, California, Forente stater, 90048
- Alexander Gershman, MD
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Newport Beach, California, Forente stater, 92660
- Stephen Auerbach, MD
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Tarzana, California, Forente stater, 91356
- Eugene Dula, MD
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Joel Kaufman, MD
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Florida
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Ocala, Florida, Forente stater, 34474
- Ira Klimberg, MD
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Idaho
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Meridian, Idaho, Forente stater, 83642
- Joseph Williams, MD
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Indiana
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Fort Wayne, Indiana, Forente stater, 46825
- Christopher Steidle, MD
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Missouri
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Saint Louis, Missouri, Forente stater, 63136
- Steven Bigg, MD
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New York
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New York, New York, Forente stater, 10016
- Jed Kaminetsky, MD
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Texas
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San Antonio, Texas, Forente stater, 78229
- William Fitch, MD
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Virginia
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Virginia Beach, Virginia, Forente stater, 23454
- Gregg Eure, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. januar 2007
Primær fullføring (Faktiske)
27. februar 2008
Studiet fullført (Faktiske)
27. februar 2008
Datoer for studieregistrering
Først innsendt
24. januar 2007
Først innsendt som oppfylte QC-kriteriene
24. januar 2007
Først lagt ut (Anslag)
26. januar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. oktober 2021
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SPI-153-06-1
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