NCT07391306招募中2 期
Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome/Interstitial Cystitis (BPS/IC)
JSC NextGen1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年2月16日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- "Number of Participants with Treatment-Related effect according to the protocol through study completion, on average, over 1 year.
研究概览
简要总结
To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to any study-related procedures.
- •Women aged 18 to 65 years, inclusive.
- •A confirmed diagnosis of painful bladder syndrome/interstitial cystitis, characterized by pelvic pain associated with filling or emptying the bladder, frequent urination day and night, with symptoms lasting at least 12 months, with the exclusion of a urinary tract infection or other disease that could cause such symptoms.
- •Absence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
- •A glycated hemoglobin level within the normal range for the patient's age group.
- •Ability to comply with all study requirements, at the discretion of the investigator, including regularly keeping a voiding diary, completing questionnaires, and attending all scheduled study visits.
- •Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.
排除标准
- •Any condition that prevents intravesical administration of medications.
- •Received medication or non-medication therapy, including physical therapy, for BPS/IC within 1 month prior to study inclusion.
- •Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.
- •History of chronic drug or alcohol abuse.
- •Pregnant women, planning to become pregnant during the study, or currently breastfeeding.
- •Any other conditions associated with pelvic pain, except for BPS
- •Pelvic surgery less than 6 months prior to the study
- •Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening
- •History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.
- •Inability to discontinue anticoagulant/antiplatelet medications at least 5 days prior to each investigational drug administration and resume them on the 4th day after each investigational drug administration (low molecular weight heparin may be used for 3 days after investigational drug administration).
- •Diseases of the urinary tract/bladder (neoplasms, tuberculous and bacterial cystitis, urolithiasis, radiation injury, urethral diverticulum, neurogenic dysfunction of the lower urinary tract) and female genital organs (neoplasms, vaginitis, genital infections).
- •Other conditions that, in the opinion of the research physician, could become an objective obstacle to the patient's participation in the study and/or create additional risks for the patient.
- •A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study.
- •Bladder capacity under anesthesia less than 150 ml.
- •Residual urine volume greater than 50 ml.
研究组 & 干预措施
The investigational therapy group
Experimental
Receiving combination therapy: coagulation of Hunner's lesions of the bladder followed by hydrobougienage and intradetrusor administration of Neovasculgen
干预措施: Neovasculgen® (Drug)
Placebo group
Placebo Comparator
Control group, receiving basic therapy: coagulation of Hunner's lesions of the bladder followed by hydrobougienage
干预措施: Placebo (Drug)
结局指标
主要结局
"Number of Participants with Treatment-Related effect according to the protocol through study completion, on average, over 1 year.
时间窗: Until the end of the study
次要结局
未报告次要终点
研究者
研究点 (1)
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