ISRCTN39853232已完成不适用
A phase II, multi-centre, double-blind, placebo-controlled, 2-way cross-over study to evaluate efficacy, plasma concentrations and safety of 0.25 mL of 20 % w/w PSD503 for topical application in female volunteer patients with stress urinary incontinence
Plethora Solutions Ltd (UK)0 个研究点目标入组 40 人开始时间: 2007年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Willing and able to provide written informed consent
- •2. Female and aged 18 - 75 years inclusive
- •3. SUI confirmed by a urinary (cough) stress test and urodynamic assessment within 36 months of Screening
- •4. SUI episode frequency >=7 and =<21 per week confirmed by a Frequency Volume Chart (FVC). If the subject has not completed a FVC prior to Screening, the subject will be asked to complete a FVC for a minimum of 3 days and to return this on Treatment Day 1
- •5. Normal filling cystometry conducted as part of a urodynamic assessment within 36 months of Screening (a bladder filling capacity of =300 mL and a first sensation of filling >100 mL)
排除标准
- •1. Has predominantly symptoms of urge urinary incontinence (>10 voids / 24 hours; >1 nocturia / night; urgency; urge incontinence) confirmed by a FVC. If the subject has not completed a FVC prior to Screening, the subject will be asked to complete a FVC for a minimum of 3 days and to return this on Treatment Day 1
- •2. Detrusor overactivity and / or a post-void residual volume >150 mL diagnosed by urodynamic examination within 36 months of screening
- •3. Unable to perform the physical exercises as required by the exercise stress pad test in the opinion of the Investigator
- •4. Current or past history of any cardiac abnormality or disease, or tachycardia, or any clinically significant abnormality in the opinion of the Investigator on electrocardiogram (ECG) at screening
- •5. Current or past history of hypertension (systolic blood pressure [SBP] =140 mmHg or a diastolic blood pressure [DBP] =90 mmHg). (If the subject has a SBP =140 mmHg or a DBP =90 mmHg on admission on any Treatment Day then they must be withdrawn)
- •6. Any significant medical history, including a current history of hyperthyroid disease, glaucoma, asthma or insulin dependent diabetes mellitus
- •7. Current or past history of (a) atherosclerotic disease including ischaemic heart disease, stroke, transient ischaemic attacks or with known aneurysm(s) or (b) vasospastic diseases e.g. Raynaud?s phenomenon and migraine
- •8. Known hypersensitivity to phenylephrine or any component in the preparation of PSD503 or has a known intolerance to sympathomimetics
- •9. Received within 4 weeks prior to screening or is continuing to receive any treatment which could:
- •a. Interact with phenylephrine (antihypertensives, atropine, monoamine-oxidase inhibitors [MAOIs], tricyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs], serotonin / noradrenaline reuptake inhibitors [SNRIs], cyclopropane, halothane, sympathomimetics, cardiac glycosides, quinidine, doxapram, oxytocin, ergotamine, methysergide, dopexamine and entacapone)
- •b. Contain phenylephrine and related substances (e.g. Sudafed and Contac)
- •c. Cause phenylephrine-like side-effects
- •10. Received or is continuing to receive any treatment for SUI in the 4 weeks prior to screening (Subjects who have consistently performed Kegel exercises for at least 4 weeks prior to Screening and are committed to continue to perform them regularly throughout the study may participate).
- •11. Urogenital prolapse >grade 1, cystocele, or has a previous history resulting in scarring in the pelvic region (e.g. surgery / radiotherapy)
- •12. History of recurring proven urinary infections (i.e. more than 2 in past year) or cystitis or is known to be suffering from any sexually transmitted disease
- •13. Lactating, or pregnant or at risk of pregnancy during the study. The subject must be either using secure contraceptive precautions, or have been surgically sterilised or be post-menopausal (defined as at least two years since the last menstrual period)
- •14. History of alcohol or drug abuse
- •15. Any clinically significant findings on urinalysis, chemical pathology, physical examination, vital signs or clinically significant concurrent illness at screening that in the opinion of the Investigator precludes inclusion / further participation in the study
- •16. Participated in a clinical trial within 30 days of screening
- •17. Unable to read and/or understand English
- •18. Unwilling or unable to abide by the protocol or in the opinion of the investigator, a subject who is not likely
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