NCT00800462已完成4 期
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Frequency of Incontinence Episodes
研究概览
简要总结
This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals with spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, between 18 and 75 years of age. Female patients of childbearing potential* must have a negative urine pregnancy test result on the day of Screening Visit and practice a reliable method of contraception**
- •*A female is considered of childbearing potential unless she is:
- •Postmenopausal for at least 12 months prior to study drug administration;
- •Without a uterus and/or both ovaries; or
- •Has been surgically sterilized for at least 6 months prior to study drug administration.
- •**Reliable methods of contraception include:
- •Hormonal methods or intrauterine device in use at least 30 days prior to study drug administration;
- •Barrier methods plus spermicidal in use at least 14 days prior to study drug administration; or
- •Sexual abstinence as a lifestyle.
- •Patients with a neurogenic bladder and detrusor overactivity secondary to a spinal cord injury.
- •Patients with urinary incontinence (minimum of one occurrence per day) despite current treatment. [NOTE: Bladder emptying may be accomplished with straining, intermittent catheterization (IC), spontaneous micturition or leakage episodes.]
- •Patients with serum creatinine within normal limits and normal renal function
- •Patients on a stable dose (minimum one month) of concomitant medication for Neurogenic detrusor overactivity
- •Patients must have adequate cognitive function to understand the requirements of the study, including completing questionnaires and signing a written Informed Consent.
排除标准
- •Female patients who are pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- •Patients with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty.
- •Patients with chronic indwelling catheters.
- •Patients with, in the opinion of the Investigator, unstable or stable multiple sclerosis.
- •Patients with known, uncontrolled systemic disease.
- •Patients with evidence of recent alcohol/drug abuse.
- •Patients with urinary retention, gastrointestinal obstructive disorders or uncontrolled narrow-angle glaucoma.
- •Patients with contraindications to Trosec™, Enablex™ and Uromax®.
- •Patients who, in the opinion of the Investigator, have a significant condition or situation that may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
- •Patients with a history of poor cooperation, non-compliance, or unreliability.
- •Patients currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Screening Visit.
- •Patients administered anticholinergics and/or antispasmodic drugs during the course of the study.
- •Patient with hepatic insufficiency.
- •Patient has been administered intravesical botulinum toxin within 6 months prior to the Screening Visit and/or is expected to receive intravesical botulinum toxin during the course of the study.
- •Patient has any medical condition that would interfere with the interpretation of the study results or the conduct of the study.
研究组 & 干预措施
Oxybutynin Cl
Active Comparator
干预措施: Oxybutynin Cl (Drug)
Trospium Cl
Active Comparator
干预措施: Trospium Cl (Drug)
Darifenacin Hydrogren Bromide (HBr)
Active Comparator
干预措施: Darifenacin Hydrogen Bromide (HBr) (Drug)
结局指标
主要结局
Frequency of Incontinence Episodes
时间窗: 3 days
Adverse Event Reporting
时间窗: Each Study Visit and Follow-up Phone Call
次要结局
- Questionnaires(Monthly)
- Urodynamic Study(Baseline and 3 months)
研究者
Magdy Hassouna
MD PhD FRCSC FACS
Toronto Rehabilitation Institute
研究点 (2)
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