NCT03482037已完成1 期
Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury
详细描述
Multicentre, double-blind, randomised, parallel groups, placebo-controlled study to be conducted in specialized centres in Europe to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of two different doses of Rec 0/0438 in comparison with placebo, in subjects with neurogenic detrusor overactivity due to spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Male and female subjects aged ≥18 years and ≤65 years.
- •Female subjects must be either sterile or, if with child-bearing potential, must have a pregnancy test negative and commit to the use of a highly effective method of birth control (see Appendix 15.6) for the duration of the study, and until at least 1 month after the last dose of study medication. Male subjects must be willing to use male contraception (condom) to avoid pregnancies of their female partner of childbearing potential throughout the entire duration of the study, and for 3 months after the last dose of study medication.
- •Suffering from NDO due to SCI at upper motor neuron level (below C6) and emptying the bladder performing clear intermittent self-catheterization (CISC).
- •Subjects classified in group A, B, or C, of the ASIA (American Spinal Injury Association) impairment scale.
- •Stable therapy for NDO in the last thirty days (Subjects should maintain the therapy stable for the duration of the study).
- •At least 1 incontinence episode/day despite current treatment, according to what is reported in the Bladder Diary filled in by the subject.
- •Subjects with diastolic blood pressure values between 60 and 99 mmHg (both inclusive), and systolic blood pressure values between 90 and 159 mmHg (both inclusive). Blood pressure measurement must be performed in subjects with an empty bladder.
- •Subjects with stable concomitant medication treatment at baseline.
- •Written informed consent must be given by subjects before any study related investigational procedures is performed.
排除标准
- •Breastfeeding women.
- •Treatment with injection of botulinum toxin, unless in the opinion of the Investigator the bladder activity has returned to pre-treatment level.
- •Use of prohibited concomitant medications, such as drugs that could affect immunoassay testing (systemic corticosteroids: prednisone, budesonide, prednisolone; calcineurin inhibitors: cyclosporine, tacrolimus; mTOR inhibitors: sirolimus, everolimus; IMDH inhibitors: azathioprine, leflunomide, mycophenolate; biologics: abatacept, adalimumab, anakinra , certolizumab, etanercept, golimumab, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; monoclonal antibodies: basiliximab, daclizumab, muromonab) or initiation of therapy with drugs affecting lower urinary tract symptoms (such as alpha-blockers, tadalafil 5 mg oad). If already present at Screening visit, therapy with drugs affecting lower urinary tract symptoms must be maintained stable through the study period (Note: occasional treatment with PDE-5 inhibitors for erectile dysfunction should be avoided between Screening visit and Day 8 and between Day 25 and 28).
- •History of cerebro- or cardio-vascular diseases (TIA, stroke, hypertensive encephalopathy, angina pectoris, MI, cardiac by-pass, CHF NYHA classes III and IV).
- •Uncontrolled type 1 or type 2 diabetes (Hb A1c >8 %).
- •Moderate to severe renal impairment (estimated creatinine clearance <60 mL/min by the Cockcroft-Gault equation).
- •Moderate to severe liver impairment (any liver function test: AST, ALT, GGT, Bilirubin >2.5 times the upper limit of normal).
- •Hemodynamically significant valve disease, including aortic stenosis or clinically significant ventricular or supraventricular arrhythmia, heart rate >100 beats/min.
- •Clinically important abnormal laboratory findings during the run-in period, including: Haemoglobin <10 g/dL; Serum Potassium >5.5 mmol/L; Serum Sodium <132 mmol/L.
- •Symptomatic active urinary tract infection (i.e. cloudy and/or malodorous urine, chills, fever, increased muscle spasticity or increased autonomic dysreflexia, letargy, hypotension, malaise).
- •Evidence of any neoplastic disease.
- •History of allergy, hypersensitivity or intolerance to drugs.
- •Participation in an investigational drug study within 30 days prior to the screening assessment.
- •Any other diseases or conditions, that according to the Investigator's opinion, make the subject unable to comply with protocol requirements, or unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.
研究组 & 干预措施
Rec 0/0438
Experimental
Rec 0/0438 1 mg (first cohort), 2 mg (second cohort) to be administered by intravesical instillation once daily for four weeks
干预措施: Rec 0/0438 1 mg or Rec 0/0438 2 mg (Drug)
Placebo
Placebo Comparator
Placebo, to be administered by intravesical instillation once daily for four weeks
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: Day 28
Treatment-emergent adverse events occurred with treatment with Rec 0/0438
次要结局
- Area Under the Curve (AUC)(Day 1 and Day 7)
- Change from baseline in Maximum Cystometric Capacity(Day 28)
- Maximum Plasma Concentration (Cmax)(Day 1 and Day 7)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
1 期
A study in male and female patients with neurogenic detrusor overactivity due to spinal cord injury to evaluate the effects of two different doses of REC 0/0438 administered by intra-vesical injection.neurogenic detrusor overactivity due to spinal cord injuryMedDRA version: 20.0Level: LLTClassification code 10005059Term: Bladder neurogenicSystem Organ Class: 100000004857EUCTR2017-000905-19-PTRecordati S.p.A36
进行中（未招募）
1 期
A study in male and female patients with neurogenic detrusor overactivity due to spinal cord injury to evaluate the effects of two different doses of REC 0/0438 administered by intra-vesical injection.neurogenic detrusor overactivity due to spinal cord injuryMedDRA version: 20.0 Level: LLT Classification code 10005059 Term: Bladder neurogenic System Organ Class: 100000004857EUCTR2017-000905-19-CZRecordati Industria Chimica e Farmaceutica S.p.A36
进行中（未招募）
1 期
A study in male and female patients with neurogenic detrusor overactivity due to spinal cord injury to evaluate the effects of two different doses of REC 0/0438 administered by intra-vesical injection.EUCTR2017-000905-19-FRRecordati S.p.A36
进行中（未招募）
1 期
A study in male and female patients with neurogenic detrusor overactivity due to spinal cord injury to evaluate the effects of two different doses of REC 0/0438 administered by intra-vesical injection.neurogenic detrusor overactivity due to spinal cord injuryMedDRA version: 20.0Level: LLTClassification code 10005059Term: Bladder neurogenicSystem Organ Class: 100000004857EUCTR2017-000905-19-PLRecordati Industria Chimica e Farmaceutica S.p.A42
已完成
1 期
The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy SubjectDiabetesNCT05737576Jiangsu HengRui Medicine Co., Ltd.61