EUCTR2005-004281-17-FR进行中（未招募）1 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-ResponseStudy to Evaluate the Safety and Efficacy of a Single Treatment of BOTOX®(Botulinum Toxin Type A) Purified Neurotoxin Complex Injected into the Prostatefor the Treatment of Lower Urinary Tract Symptoms in Patients due to BenignProstatic Hyperplasia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male, aged 50 years and older
- •2. Weight at least 50 kg
- •3. Lower urinary tract symptoms in patients due to benign prostatic hyperplasia
- •based on medical history and digital rectal exam, respectively.
- •4. Lower urinary tract symptoms (except incontinence) for at least 3 months by
- •patient report. These symptoms may include any or all of the following
- •obstructive or irritative symptoms: weak urinary stream, prolonged voiding,
- •abdominal straining, hesitancy, intermittency, incomplete bladder emptying,
- •dribbling, frequency, nocturia, urgency, bladder pain, and dysuria.
- •5. International Prostate Symptom Score (IPSS) greater than or equal to 12 at the
- •screening visit (day -14).
- •6. Total prostate volume by transrectal ultrasound of at least 30 mL but not greater
- •than 100 mL determined at the screening visit (day -14).
- •7. Peak urinary flow rate of at least 5 mL/sec, but not greater than 15 mL/sec with
- •a voided urine volume of at least 125 mL at the screening visit (day -14).
- •8. Post void residual urine volume less than 200 mL measured by ultrasound or
- •bladder scan at the screening visit (day -14).
- •9. If engaging in sexual activities, all patients must use a male condom for 3
- •months post-treatment irrespective of other contraceptive methods (e.g.,
- •vasectomy).
- •Patient with a partner of child-bearing potential must also use a spermicide gel
- •or cream with the male condom, if patient has not had a vasectomy or the
- •female partner is not using an oral, patch, injectable contraceptive or
- •intrauterine device (if she has not had a tubal ligation or hysterectomy).
- •10. Written informed consent obtained including information regarding the
- •collection, use, disclosure and protection of their personal information
- •(Canadian sites only) or Data Protection Consent (European sites only).
- •11. Patient is registered in the French social security system and fulfils necessary
- •requirements as required by local law (French sites only).
- •12. Able and willing to comply with study instructions and visit schedule.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous prostate surgery, including minimally invasive procedures (e.g.,
- •transurethral needle ablation, transurethral microwave therapy)
- •2. Any prostate biopsy within 6 weeks of the screening visit (day -14). Patients
- •will be allowed to be re-screened a minimum of 6 weeks after a negative biopsy
- •result is documented. All other protocol inclusion and exclusion criteria must
- •3. Prominent medial lobe at the screening visit (day -14), as determined by the
- •investigator’s opinion (e.g., transrectal ultrasound or previous cystoscopy).
- •4. Previous or current diagnosis of prostate cancer.
- •5. Patient with a Prostate Specific Antigen (PSA) greater than 10 µg/L may not be
- •enrolled. Patients with a total PSA greater than or equal to 4.0 µg/L and less than
- •or equal to 10 µg/L must have prostate cancer ruled out to the satisfaction of the
- •investigator according to local site practice.
- •6. Alpha-adrenergic antagonists within 15 days prior to the screening visit (day -
- •14) and patient is unwilling to remain off the medication for duration of the
- •7. Medications in the following classes within 15 days of the screening visit (day -
- •14) and patient is unwilling or unable to remain off chronic use of these
- •medications for the duration of the study.
- •Alpha-adrenergic agonists
- •Drugs with anticholinergic/antimuscarinic activity if they are indicated for
- •any form of urinary symptoms or bowel disease
- •Antispasmodics, including those indicated for gastrointestinal discomfort
- •8. Medication in the following classes within 90 days of the screening visit (day -
- •14) and throughout the duration of the study.
- •5-alpha-reductase inhibitors
- •Androgens
- •Drugs with anti-androgenic activity (e.g., spironolactone)
- •9. Phytotherapy taken for the treatment of prostate diseases or non-specific urinary
- •symptoms within 30 days of the screening visit (day -14) and throughout the
- •duration of the study.
- •10. Medications with anti-platelet or anti-coagulant (e.g., including acetylsalicylic
- •acid) effect are prohibited for a minimum of 3 days or longer according to
- •clinical judgment of the investigator, prior to any study treatment until the end
- •of the day of treatment (refer to Section 8.2.2 Prohibited
- •Medications/Treatments for details).
- •11. Symptomatic prostatitis (acute or chronic) within 12 months of the screening
- •visit (day -14), as determined by patient history.
- •12. History or evidence of any urologic abnormalities (e.g., urethral stricture),
- •bladder surgery, or disease (other than BPH) that may impact bladder function.
- •13. Recurrent urinary tract infections (UTI) defined as 2 or more episodes in the 12
- •months prior to the screening visit (day -14) or UTI in the last 6 months prior to
- •randomization/ treatment visit (day 1).
- •14. Urinary infection defined as a bacteriuria count of >10^4 CFU/mL conjoint with
- •leukocyturia >5/hpf at the screening visit (day -14). In addition, patients with a
- •lower bacteriuria count who, in the opinion of the investigator, have a UTI
- •should also be excluded.
- •15. Urinary tract infection (symptomatic or asymptomatic) at the treatment visit
- •(day 1), prior to randomization. Asymptomatic urinary tract infection defined as
- •positive nitrites, blood and/or leukocyte esterase on urine dipstick reagent test
- •16. History or evidence of interstitial cystitis based on the investigator’s opinion.
- •17. History or evidence of bladder cancer.
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