JPRN-UMIN000003907已完成未知
A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria. - A pilot study of generic Tamsulosin for benign prostatic hyperplasia patients with dysuria.
PO MINS0 个研究点目标入组 20 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
The I-PSS and the QOL score were significantly decreased after 4 weeks dosing of Restream®. And the safety profile was similar to that of the original drug. These results confirmed that 4 weeks treatment by the generic drug of Tamsulosin Hydrochloride, Restream®OD tablet, would be effective and be safety for BPH with moderate to severe dysuria.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50years-old 至 90years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1) Patients who treated by medicine that has androgenic hormone within 4 weeks before IC. 2) Patients with cases or suspicion of prostatic cancer 3) Patients with suspicion of neurogenic bladder 4) Patients with urethral stricture 5) Patients with chronic bacterial prostatitis or active urinary tract infection 6) Past history of surgery or invasive therapy for BPH. 7) Irradiation for pelvic area within 1 year prior to IC. 8) Patients with any disease that induce dysuria (such as bladder neck contracture or urolithiasis) 9) Patients with cardiovascular disease. 10) Patients with serious disease or impairment of liver, kidney and blood 11) patients who are participated in any clinical studies within 3 months prior to the study 12) Patients who are judged inappropriate for the clinical trial by the investigator
研究者
相似试验
已完成
1 期
Bioequivalence Study of Tamsulosin 0.4 mg Sustained Release Film-coated TabletsHealthyNCT06558032Dexa Medica Group28
已完成
2 期
Effect of tamsulosin on reducing discomfort caused by ureteral stentingDiscomfort after ureteral stenting in patients with urolithiasis.Calculus of kidney and ureterIRCT2015042221886N2Exir Pharmaceutical Company70
已完成
不适用
A preliminary study of the effects of a new oral mucosa protective material on chemotherapy- and/or radiation-induced oral mucositisJPRN-UMIN000031921ational Cancer Center Hospital10
已完成
1 期
CKD-397 Drug-drug Interaction Study (A)HealthyNCT02247518Chong Kun Dang Pharmaceutical16
Unknown
不适用
Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)Benign Prostatic HyperplasiaNCT01404637Samsung Medical Center150