Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Change From Baseline 24-hour Urinary Free Cortisol Level
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject must be 6 to <18 years of age, of either sex, and of any race.
- •A subject must have a diagnosis of bilateral nasal polyps.
- •A subject must have a minimum nasal congestion/obstruction
- •An asthmatic subject may be included.
- •A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.
- •The subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules.
- •A female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to Screening and must continue using it while receiving protocol-specified medication. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit
排除标准
- •A subject with antrochoanal polyps.
- •A subject with cystic fibrosis.
- •A subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the Screening Visit.
- •A subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
- •A subject who is immunocompromised.
- •A subject with ongoing rhinitis medicamentosa.
- •A subject with Churg Strauss syndrome.
- •A subject with dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immotile cilia).
- •A subject with any clinically significant pretreatment laboratory, vital sign, or ECG abnormality.
- •A subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients.
- •A subject who has not observed the medication washout times outlined in the protocol prior to the Screening Visit.
- •A female subject who is breast-feeding, pregnant, or intends to become pregnant.
- •A subject who has used any investigational drug within 30 days of Screening.
- •A subject who is part of the staff personnel directly involved with this study.
研究组 & 干预措施
MFNS 100 mcg QD for subjects 6 to less than 12 years
Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age
干预措施: Mometasone Furoate Nasal Spray (MFNS) (Drug)
Placebo QD for subjects 6 to less than 12 years
干预措施: Placebo nasal spray (Drug)
MFNS 200 mcg QD for subjects 12 to less than 18 years
干预措施: Mometasone Furoate Nasal Spray (MFNS) (Drug)
MFNS 200 mcg BID for subjects 12 to less than 18 years
干预措施: Mometasone Furoate Nasal Spray (MFNS) (Drug)
Placebo QD for subjects 12 to less than 18 years
干预措施: Placebo nasal spray (Drug)
MFNS 100 mcg BID for subjects 6 to less than 12 years
干预措施: Mometasone Furoate Nasal Spray (MFNS) (Drug)
Placebo BID for subjects 6 to less than 12 years
干预措施: Placebo nasal spray (Drug)
Placebo BID for subjects 12 to less than 18 years
干预措施: Placebo nasal spray (Drug)
结局指标
主要结局
Change From Baseline 24-hour Urinary Free Cortisol Level
时间窗: Baseline to Endpoint
The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to \<18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level.
次要结局
- Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine(Baseline to Endpoint)