A Phase 4, Multiple-dose, Pharmacokinetic, Safety, and Exploratory Efficacy Study of Nitroglycerin Ointment 0.4% (RECTIV®) in Adolescents (Age ≥12 to <17 Years) With Moderate to Severe Pain Due to Chronic Anal Fissure
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Noncompartmental pharmacokinetic (PK) analyses will be performed on the full pharmacokinetic curves for NTG and its metabolites (1,2 glyceryl dinitrate and 1,3 glyceryl dinitrate) on Day 5
研究概览
简要总结
RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to severe pain associated with chronic anal fissure approved in June 2011 by the US Food and Drug Administration (FDA) for adults. The purpose of this study is to assess the safety, pharmacokinetics, and exploratory efficacy of RECTIV® in adolescents
详细描述
This is an open-label, multicenter study conducted in up to 10 sites in the United States. A total of 13 pediatric male or female patients age ≥12 to <17 years will be enrolled. The patients will administer a dose of Rectiv® twice daily to characterize the safety, pharmacokinetics , and exploratory efficacy of Nitroglycerin Ointment 0.4% (RECTIV® )over 5 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥12 and <17 years of age
- •At least 1 anal fissure for a minimum of 3 weeks in duration
- •Anal fissure pain experienced over the last 24 hours at Screening and before enrollment
- •Patient (and parent or caregiver as appropriate) has provided written informed consent
排除标准
- •Current diagnosis of hemorrhoids
- •Hypersensitivity, allergy, or contraindication to nitroglycerin
- •History of hypertension and/or cardiovascular disease
- •History or current diagnosis of inflammatory bowel disease
- •History or current diagnosis of fistula(e)-in-ano or an anal abscess
- •Fibrotic anal stenosis
- •Previous anal surgery
- •Diagnosis of cancer
- •History of migraine or chronic headaches requiring treatment with analgesics
- •Pregnant or lactating female patients
- •Weight <36 kg
研究组 & 干预措施
Rectiv
干预措施: Nitroglycerin Ointment 0.4% (Drug)
结局指标
主要结局
Noncompartmental pharmacokinetic (PK) analyses will be performed on the full pharmacokinetic curves for NTG and its metabolites (1,2 glyceryl dinitrate and 1,3 glyceryl dinitrate) on Day 5
时间窗: Day 5
The following PK parameters will be calculated as data permit: * Maximum observed concentration (Cmax) * Time of the maximum observed plasma concentration (Tmax) * Area under the concentration time curve from dosing up to the last quantifiable concentration (AUC0-last). * Area under the concentration time curve from dosing up to 480 minutes (AUC0-480) * The extrapolated area under the concentration time curve from dosing up to 12 hours (AUC0-12h) also will be calculated if quantifiable concentrations are observed during the entire dose interval. * Terminal elimination half-life (t1/2) On the basis of the results of the study, additional noncompartmental PK parameters may be calculated and reported. In addition, a population PK model for NTG will be developed based on the PK data from Day 5. By using this model, the following additional PK parameters may be reported: * Apparent volume of distribution (V/F) * Apparent clearance (CL/F)
次要结局
- • Absolute change from baseline in 24-hour average anal fissure pain scores assessed by the Wong-Baker FACES® and the Numerical Rating Scale for pain after each evening dose over days 1 through 4(Day 5)