NCT01598103终止2 期
A Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Efficacy, Safety and Tolerability of SAF312 in Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions Who Are Inadequately Managed by Antimuscarinic Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum cystometric capacity (MCC)
研究概览
简要总结
This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with neurogenic detrusor overactivity due to spinal cord lesions
- •Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL
排除标准
- •Chronic inflammation such as interstitial cystitis, bladder stones, hematuria of unknown origin, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- •Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function
研究组 & 干预措施
Placebo to SAF312
Placebo Comparator
干预措施: Placebo to SAF312 (Drug)
SAF312
Experimental
干预措施: SAF312 (Drug)
结局指标
主要结局
Maximum cystometric capacity (MCC)
时间窗: 1 week
Examined during filling cystometry as measured by changes from baseline following treatment for one week.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety(1 week)
- Bladder threshold vol, threshold pressure, instilled vol at first leak, detrusor pressure at first leak, vol/detrusor pressure at first sensation and at first desire to void, maximum detrusor pressure during filling/storage, bladder wall compliance(1 week)
- Incontinence episodes(1 week)
- Micturition or catheterization frequency(1 week)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Efficacy and Tolerability of BAF312 in Patients With PolymyositisPolymyositisNCT01801917Novartis Pharmaceuticals14
已完成
1 期
Pharmacokinetics of BAF312 in Patients With Hepatic ImpairmentHepatic ImpairmentNCT01565902Novartis Pharmaceuticals40
终止
2 期
Safety and Efficacy of BAF312 in DermatomyositisActive DermatomyositisNCT02029274Novartis Pharmaceuticals17
已完成
2 期
Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)Chronic Ocular PainNCT04630158Novartis Pharmaceuticals153
终止
2 期
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and DermatomyositisPolymyositisDermatomyositisNCT01148810Novartis Pharmaceuticals18