EUCTR2007-005793-31-GB进行中（未招募）不适用
A phase II, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 3236 tablets in men with Lower Urinary Tract Symptoms (LUTS) suggestive of Benign Prostatic Hyperplasia (BPH)
V Organon0 个研究点目标入组 240 人开始时间: 2008年2月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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. Signed written informed consent, obtained before screening evaluations;
- •2. Men diagnosed with LUTS suggestive of BPH:
- •2.1. Baseline IPSS score of = 12 (moderate to severe);
- •2.2. Prostate volume of = 40 mL and < 100 mL (based on TRUS);
- •2.3. Peak urinary flow rate = 15 mL/s with a voided volume of = 125 mL;
- •3. Age at least 50 but not older than 80 years at screening;
- •4. PSA < 10 ng/mL and exclusion of prostate cancer to the satisfaction of the investigator (e.g. by biopsy).
- •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
- •5. A postvoid residual volume >250 mL;
- •6. Use of anti-androgens, androgens, Gonadotropin Releasing Hormone (GnRH) antagonists, or 5a-reductase inhibitors within six months prior to start trial medication;
- •7. Use of a-blockers, phytotherapy (for LUTS) or drugs interfering with bladder function within two weeks prior to start trial medication;
- •8. Presence of hypogonadism as judged by the (sub)investigator;
- •9. Acute urinary retention within the past 12 months;
- •10. History of surgery for BPH, including other minimally invasive procedures;
- •11. Presence of urinary tract infection;
- •12. Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation;
- •13. Presence or history (within the past 12 months) of depression or other psychiatric disease of moderate or severe intensity;
- •14. Cardiac or cerebrovascular event within the past six months;
- •15. Presence or history of any neurological disease associated with primary bladder dysfunction;
- •16. Presence or history of liver disease or disturbance of liver function that failed to return to normal;
- •17. Presence or history of renal disease or disturbance of renal function that failed to return to normal;
- •18. Present use or use within two months prior to screening of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, hydantoins, rifampicin, ritonavir, nelfinavir, and griseofulvin;
- •19. Presence or history (within the past 12 months) of alcohol or drug abuse as judged by the (sub)investigator;
- •20. Clinically relevant abnormal laboratory result as judged by the (sub)investigator;
- •21. Known hypersensitivity to any of the components of trial medication;
- •22. Administration of investigational drugs and/or participation in another clinical trial within two months prior to screening.
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