Interstitial Cystitis Clinical Research Network (ICCRN)

间质性膀胱炎临床研究网络 (ICCRN)

• 批准号: 6682207
• 负责人: JOHN CURTIS NICKEL
• 金额: $ 8.12万
• 依托单位: QUEEN'S UNIVERSITY AT KINGSTON
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-02 至 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6682207
• 关键词: amitriptyline; anticonvulsants; chronic pain; clinical research; clinical trials; combination chemotherapy; cooperative study; experimental designs; human subject; human therapy evaluation; interdisciplinary collaboration; interstitial cystitis; patient oriented research; pelvis; prostatitis; quality of life; questionnaires; sign /symptom; statistics /biometry; urinalysis; urinary tract disorder chemotherapy

The RFA specifically requests that the applicants confirm their interest and ability to take part in clinical treatment trials in Intersitial Cystitis (IC). The Queen's University Intersitial Cystitis Research Group is established under the directorship of Dr. J. Curtis Nickel in Kingston, Canada and recently expanded to take part in the NIH ICCTG RCT #2. The Queen's University Intersitial Cystitis Research Group has enrolled 255 patients in 12 clinical trials, specifically in clinical IC treatment studies (this does not include the many patients recruited for etiology and diagnostic studies during the same time period). As part of the NIH ICCTG, the Queen's University site has exceeded its enrollment quota to date for RCT #2.. The interstitial cystitis research group is closely affiliated with the Queen's University Prostatitis Research Group (PI Dr. J.C. Nickel) which is collaborating in the NIH CPCRN (including CPCRN RCT#1). The Prostatitis research center is also meeting its recruitment quota in RCT#1. To our knowledge the Queen's University Prostatitis Research Center has initiated more prostatitis treatment trials and has enrolled more patients than any such research group worldwide. This application describes our aim to participate in the proposed NIH ICCRN as well as the proposed urological chronic pelvic pain syndromes collaborative group (UCPPSCG). Our group is proposing a clinically relevant definition of the urologic chronic pelvic pain syndromes encompassing both IC and male CPPS. This definition, based on chronic genito-urinary pain/discomfort with subcategories for urinary frequency urgency and no urinary frequency urgency will, if adopted by the UCPPSCG, facilitate decisions on treatments to be evaluated and increase the accrual rate of study participants in both IC and CPPS. We develop a rationale, hypothesis, objectives necessary to propose a 16 week randomized placebo controlled clinical trial (employing 2X2 factorial design) to evaluate the efficacy and safety of amitriptyline and gabapentin for the amelioration of symptoms in patients with a clinical diagnosis of IC. The Queen's University. site with Dr. Nickel as PI has the experience, expertise and the proven ability to design, implement and enroll patients with IC in clinical strudies and will be a valuable partner in the proposed ICCRN and UCPPSCG.

RFA特别要求申请人确认他们有兴趣和能力参加间质性膀胱炎（IC）的临床治疗试验。女王大学间质性膀胱炎研究小组是在加拿大金斯敦J. Curtis Nickel博士的领导下成立的，最近扩大了参与NIH ICCTG RCT #2的范围。女王大学间质性膀胱炎研究小组在12项临床试验中招募了255名患者，特别是在临床IC治疗研究中（这不包括在同一时期招募的许多患者进行病因学和诊断研究）。作为NIH ICCTG的一部分，女王大学网站迄今为止已经超过了RCT #2的入学配额。间质性膀胱炎研究小组与皇后大学前列腺炎研究小组（PI博士J.C. Nickel）密切相关，后者正在NIH CPCRN（包括CPCRN RCT#1）中合作。前列腺炎的研究