A MULTICENTERED RANDOMIZED STUDY OF CELEBREX (CELECOXIB)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 该方案是一项为期30个月的多中心随机、双盲对照研究，使用塞来昔布治疗成人和儿童反复呼吸道乳头状瘤病患者。这项研究的主要目标将是确定选择性COX-2抑制剂Celebrex是否可以降低这些患者可见的乳头状瘤的复发率。研究人群将是两岁或两岁以上患有中到重度复发性呼吸道乳头状瘤病的患者。所有患者将在登记时进行疾病严重程度评估，每隔3个月进行一次，为期30个月。在登记后大约5个月，患者将随机分为早期治疗组或延迟治疗组。早期治疗组的患者将在登记6个月后开始塞来昔布治疗。延迟治疗的分支将在登记18个月后开始塞来昔布。所有成年患者每日口服Celebrex 400 mg，疗程1年。儿童服用的剂量将减少，具体取决于体重和年龄。在患者未接受塞来昔布治疗的期间，他们将接受外观相同的安慰剂胶囊。在研究期间，将每隔三个月进行一次随访和内窥镜检查。

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.