Marian Anderson Sickle Cell Center - Sickle Cell Disease

玛丽安安德森镰状细胞中心 - 镰状细胞病

• 批准号: 7059800
• 负责人: Carlton Dampier
• 金额: $ 19.78万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7059800
• 关键词: adolescence (12-20); adult human (21+); amitriptyline; analgesia; chemoprevention; clinical research; clinical trials; cognitive behavior therapy; cooperative study; dosage; drug administration rate /duration; drug screening /evaluation; headache; human subject; human therapy evaluation; medical complication; middle childhood (6-11); migraine; morphine; nervous system disorder chemotherapy; patient oriented research; sickle cell anemia; valproate

DESCRIPTION (provided by applicant): This Clinical Center will provide support for state-of-the-art clinical research activities for 962 SCD patients at St. Christopher's Hospital for Children (SCHC), Thomas Jefferson University Hospital (TJUH), Kosair Children's Hospital (KCH), and duPont Children's Hospital (DCH). Three of these sites (SCHC, KCH, TJUH) are currently part of the Marian Anderson Comprehensive (MAC) Sickle Cell Center and currently lead enrollment in several of the phase l/ll/lll Inter-Center studies sponsored by the Comprehensive Centers, also under the direction of Dr. Dampier and Ms. Rockstein through the MAC Center's Clinical Core. The Center PI and Center Chief Clinical coordinator at St. Christopher's Hospital are both credentialed by the Association of Clinical Research Professionals (Clinical Trial Investigator, and CRA certifications respectively) and have a several year record of successful coordination and supervision of research activities at the various Center sites. The proposed network clinical trials address important issues in clinical care of SCD patients. The first study is a phase IV of headache management that will build on descriptive and epidemiologic data being gathered as part of the C-data project of the Comprehensive Center's Network. This study proposes a 4 month placebo controlled RCT of prophylactic therapy (amitryptline with or without CBT training) in children aged 7- 17 years with >/= 2 headaches per month in the preceding 3 months, while a companion study will evaluate the effectiveness of amitriptyline or divalproex ER in reducing the number of days of recurrent headaches in a 4 month double blind, parallel treatment, placebo-controlled trial of adults with >/= 2 migraine headaches per month. The second clinical trial will examine the efficacy of two alternative morphine PCA dosing regimens in comparison to a standard PCA therapy. It will also determine whether variations in morphine pharmacokinetics, in morphine pharmacodynamics as determined by pharmacogenetics, or subject psychosocial factors, alter the efficacy of the various PCA regimens. An Outcomes Core is also proposed which will focus on developing a variety of outcome measures and descriptive clinical information to support the appropriate, conduct of high quality clinical trials of therapies for sickle cell-related pain. The performance of these studies will advance the clinical understanding of sickle cell-related pain and its consequences. Their results will stimulate the development of innovative clinical trials of sickle pain. (End of abstract)

描述（由申请人提供）： 该临床中心将为圣克里斯托弗儿童医院 (SCHC)、托马斯杰斐逊大学医院 (TJUH)、Kosair 儿童医院 (KCH) 和杜邦儿童医院的 962 名 SCD 患者提供最先进的临床研究活动支持医院（DCH）。其中三个中心（SCHC、KCH、TJUH）目前是玛丽安安德森综合 (MAC) 镰状细胞中心的一部分，目前在由综合中心赞助的多项 l/ll/lll 期中心间研究中处于领先地位，在 Dampier 博士和 Rockstein 女士通过 MAC 中心临床核心的指导下进行。圣克里斯托弗医院的中心 PI 和中心首席临床协调员均获得临床研究专业人员协会的认证（分别为临床试验研究者和 CRA 认证），并拥有多年成功协调和监督各个医院研究活动的记录。中心站点。拟议的网络临床试验解决了 SCD 患者临床护理中的重要问题。第一项研究是头痛管理的第四阶段，该研究将建立在作为综合中心网络 C 数据项目一部分收集的描述性和流行病学数据的基础上。本研究建议对过去 3 个月内每月≥2 次头痛的 7-17 岁儿童进行为期 4 个月的安慰剂对照随机对照预防性治疗（阿米替林，有或没有 CBT 训练），同时一项伴随研究将评估预防性治疗的有效性在一项为期 4 个月的双盲、平行治疗、安慰剂对照试验中，阿米替林或双丙戊酸钠缓释片可减少头痛复发的天数，试验对象为患有 >/= 2 级偏头痛的成人每个月都会头痛。第二项临床试验将检查两种替代吗啡 PCA 给药方案与标准 PCA 疗法相比的疗效。它还将确定吗啡药代动力学、由药物遗传学确定的吗啡药效学或受试者心理社会因素的变化是否会改变各种 PCA 方案的功效。还提出了一个结果核心，该核心将侧重于开发各种结果测量和描述性临床信息，以支持对镰状细胞相关疼痛疗法进行适当的、高质量的临床试验。 这些研究的进行将增进对镰状细胞相关疼痛及其后果的临床理解。他们的结果将刺激镰状痛创新临床试验的发展。 （摘要结束）