EUCTR2006-002663-11-GB进行中（未招募）1 期
An open-label, escalating dose, proof of concept study to determine the effects of single oral doses of PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
入选标准
- •1. Male or female subjects, aged 18 years or over
- •2. Spinal lesion above T12, which has been stable for at least 6 months prior to screening
- •3. Detrusor hyper- reflexia secondary to spinal injury(mid-thoracic or cervical level) present for at least 12 months
- •4. If female, must either be surgically sterile or post-menopausal for the past year confirmed by a negative hormone panel (luteinizing hormone [LH], follicle stimulating hormone [FSH], 17ß estradiol), or if of child-bearing potential be on adequate non-hormonal contraception (not oral or injectable) i.e. double barrier method or intrauterine contraceptive device [IUCD]. If male must also use adequate contraception (hormonal methods permitted)
- •5. Anti-muscarinic-naïve or treated subjects completing the 5 day wash-out period
- •6. Written informed consent
- •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. If female, has a positive urine pregnancy test
- •2. History of drug or alcohol abuse
- •3. Use of anti-muscarinic agents with a long-half life e.g. solifenacin
- •4. Body Mass Index (BMI) greater than 28 or less than 16
- •5. Mean sitting BP greater than 150/85 or less than 100/60mmHg
- •6. Mean HR greater than 90 bpm or less than 50 bpm
- •7. Clinically significant orthostatic hypotension present at screening
- •8. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
- •9. History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure
- •10. History of significant central nervous system disease, including: transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances
- •11. History of peripheral vascular or cerebrovascular disease
- •12. History of narrow angle glaucoma or increased ocular pressure
- •13. Clinically significant bladder pathology, including urinary tract infection within 6 weeks of Day 0
- •14. History of diabetes
- •15. Clinically significant GI disorder which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- •16. History of clinically significant liver disease, e.g., hepatitis B
- •17. Prohibited medications taken within 2 weeks
- •18. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp)
- •19. Clinically significant abnormalities in laboratory test results at screening (including hepatic and renal, full blood count, biochemistry and urinalysis)
- •20. Participation in an investigational drug or device study within 30 days prior to study
- •21. Known hypersensitivity to anticholinergic agents
- •22. Concomitant disease or condition which could interfere with, or for which the treatment of might interfere with, the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. This would include, but is not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
- •23. Unwillingness or inability to comply with the study protocol for any other reason
- •24. Any clinically significant abnormality on 12-lead ECG.
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