A STUDY OF CELEBREX IN PATIENTS WITH RESPIRATORY PAPILLOMATOSIS

塞来昔布治疗呼吸道乳头状瘤病患者的研究

• 批准号: 7951948
• 负责人: BETTIE M. STEINBERG
• 金额: $ 0.52万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951948
• 关键词: Adult; Age; Appearance; Child; Childhood; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Double-Blind Method; Early treatment; Endoscopy; Enrollment; Funding; Grant; Institution; PTGS2 gene; Papilloma; Patients; Placebos; Population Study; Protocols documentation; Randomized; Recurrence; Research; Research Personnel; Resources; Severity of illness; Source; Time; United States National Institutes of Health; Upper arm; Visit; Weight; capsule; celecoxib; follow-up; inhibitor/antagonist; respiratory

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This protocol is a multicentered randomized double blind controlled 30-month study of Celebrex (celecoxib) in adult and pediatric patients with recurrent respiratory papillomatosis. The primary objective of the study will be to determine whether Celebrex, a selective COX-2 inhibitor, can decrease the rate of recurrence of visible papillomas in these patients. The study population will be patients age two or older with moderate to severe recurrent respiratory papillomatosis. All patients will be evaluated for disease severity at enrollment and at 3-month intervals for 30 months. Approximately 5 months after enrollment, patients will be randomized into either the early or delayed treatment group. Patients in the early treatment arm will begin celecoxib treatment 6 months after enrollment. The delayed treatment arm will begin celecoxib 18 months after enrollment. All adult patients will take Celebrex 400 mg once daily orally for 1 year. Children will take a reduced dose, determined by weight and age. During the time that patients do not receive celecoxib, they will receive a placebo capsule with the same appearance. Follow-up visits and endoscopies will occur at three-month intervals for the duration of the study.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 该方案是一项多中心随机双盲控制的Celebrex（Celecoxib）的30个月研究（Celecoxib）在成人和小儿复发性呼吸乳头状瘤病患者中。 该研究的主要目的是确定选择性COX-2抑制剂Celebrex是否可以降低这些患者可见乳头瘤的复发率。 该研究人群将是两岁或两岁的患者，患有中度至重度复发性呼吸乳头状瘤病。 所有患者将在入学时对疾病的严重程度进行评估，并以3个月的间隔评估30个月的时间。 入学率大约5个月后，患者将被随机分为早期或延迟治疗组。 早期治疗组中的患者将在入学后6个月开始塞雷科昔布治疗。 延迟的治疗臂将在入学后18个月开始塞来昔布。 所有成年患者每天口服一次400毫克Celebrex 1年。儿童将减少剂量，取决于体重和年龄。 在患者未接受塞来昔布时，他们将获得具有相同外观的安慰剂胶囊。 在研究期间，随访和内窥镜将以三个月的间隔进行。