NCT02709538已完成3 期
A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
Glenmark Specialty S.A.34 个研究点 分布在 1 个国家目标入组 601 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 601
- 试验地点
- 34
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs).
研究概览
简要总结
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥12 years and older inclusive of either sex.
- •Documented clinical history of PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.
排除标准
- •Pregnant or lactating women.
- •History of anaphylaxis and/or other severe local reaction(s) to skin testing.
- •History of positive test for HIV, Hepatitis B or Hepatitis C infection.
- •Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
- •Subjects with an active pulmonary disorder or infection.
- •Subjects with posterior subcapsular cataracts or glaucoma
研究组 & 干预措施
GSP 301 NS
Experimental
干预措施: GSP 301 NS (Drug)
GSP 301 Placebo NS pH 3.7
Placebo Comparator
干预措施: GSP 301 Placebo NS pH 3.7 (Drug)
GSP 301 Placebo NS pH 7.0
Placebo Comparator
干预措施: GSP 301 Placebo NS pH 7.0 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
时间窗: 52 weeks
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
次要结局
未报告次要终点
研究者
研究点 (34)
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