EUCTR2006-004380-58-NL进行中（未招募）1 期
A MULTI-CENTER, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, THIRD PARTY OPEN, PLACEBO CONTROLLED, PILOT STUDY TO ASSESS THE URODYNAMIC EFFECTS OF MODIFIED RELEASE UK-369,003 IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •*Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) =13 at both screening and baseline
- •*Clinical diagnosis of BPH
- •*Qmax 5 to 15 ml/sec with a voided volume of >150 ml at screening visit.
- •*Urodynamically defined bladder outlet obstruction based on bladder outlet obstruction index >40; calculated as PdetQmax –2Qmax and measured at visit 2
- •(baseline).
- •*A minimum of 50% of the patient population will also have urodynamically confirmed DO (an involuntary detrusor contraction of = 10cm H2O during baseline filling cystometry and volume to first contraction = 350ml)
- •*Evidence of a personally signed and dated informed consent document indicating
- •that the subject (or a legally acceptable representative) has been informed of all
- •pertinent aspects of the trial.
- •*Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
- •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
- •*History, evidence or suspicion of prostate cancer (includes total PSA value > 10 ng/ml unless prostate cancer previously excluded by biopsy)
- •*Post-void residual urine volume >200 ml based on bladder ultrasound at screening
- •*Documented UTI; subjects with a positive (1+ or greater) leukocyte or nitrite result in urine dipstick test will be excluded unless UTI can be ruled out via urine culture.
- •*Greater than 1+ of hematuria on dipstick test, unless fully investigated prior to
- •randomization to rule out significant urological disease.
- •*History of relevant urological surgery or procedures that may contribute to LUTS (e.g. prostatectomy, bladder neck surgery, minimally invasive procedures of the prostate, prostatic stent insertion, pelvic irradiation, cystoscopy < 30 days prior to randomization)
- •*Chronic persistent local lower urinary tract pathology (e.g. bladder neck contracture, prostatitis, bladder stone, cystitis, urethral stricture, carcinoma, large bladder diverticulum, recurrent gross hematuria).
- •*Known primary neurological condition such as multiple sclerosis, Parkinson’s disease, or other neurological diseases known to affect bladder function.
- •*History of catheterization for outflow obstruction in the previous 12 month (includes intermittent self-catheterization).
- •*Subjects with history of difficult catheterization.
- •*Subjects receiving or who are likely to receive during the study any of the medications:
- •a-blockers, muscarinic receptor antagonists, PDE5 inhibitors, and agents known to affect vesico-urethral function.
- •5-a-RIs
- •Diuretics, beta-blockers or other anti-hypertensive agents
- •Nitrates or nitric oxide donors in any form on either regular or intermittent basis (oral, sublingual, buccal, transdermal, inhalation or aerosols).
- •Potent CYP3A4 inhibitors
- •Topical agents are permitted.
- •Warfarin.
- •*Significant allergy to or known hypersensitivity or intolerance to PDE5 inhibitors.
- •*Increased susceptibility to vasodilators including those with left ventricular
- •outflow obstruction (e.g., hypertrophic obstructive cardiomyopathy)
- •*Poorly controlled type I or type II diabetes mellitus as defined by Hemoglobin
- •*Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporarily associated with the use of a PDE5 inhibitor.
- •*Hereditary degenerative retinal disorders (e.g. retinitis pigmentosa).
- •*History of recurrent syncope or evidence of low blood pressure (BP) (<90mmHg systolic or <40mmHg diastolic) or evidence of symptomatic postural hypotension. This includes relevant postural symptoms associated with fall in systolic BP of > 20 mmHg or diastolic BP > 10 mmHg on standing.
- •*Any relevant clinically significant abnormalities on the screening physical examination or laboratory tests including patients with moderate liver function
- •tests abnormalities (>1.5 x upper limit of normal) and renal function abnormalities (serum creatinine =2.5 mg/dl or =220 µmol/l).
- •*Family history of prolonged QT syndrome or who themselves have a QTc of >450msec at the screening visit as measured by a 12-lead supine ECG.
- •*Risk of priapism e.g. sickle cell disease, multiple myeloma and myeloproliferative disorders (e.g. myeloid leukemia, polycythemia, thrombocythemia).
- •*Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with
- •the requirements of the protocol, including: de
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