NCT00447837已完成2 期
A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC-AB01, Tobramycin Solution for Nasal Inhalation, in Post-Surgical Subjects With Chronic Sinusitis
Naryx Pharma43 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 43
- 主要终点
- Change from baseline in TSSS during first week post-therapy
研究概览
简要总结
The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient subjects who have signed a written informed consent.
- •A documented history of chronic sinusitis with clinical signs and symptoms suggestive of inflammation or infection for at least 90 consecutive days.
- •A documented history of sinus surgery > 90 days.
- •Nasal endoscopic exam documenting purulence (pus) from an open sinus cavity with mucosal swelling/edema.
- •Women of childbearing potential must have a negative serum pregnancy test and must use adequate birth control throughout the study.
排除标准
- •Pregnant females and females unwilling to use adequate birth control.
- •Use of any investigational drug/device within 30 days of study screening.
- •The following medications will require a certain washout period as determined by the protocol: systemic corticosteroids, mast cells and/or leukotriene inhibitors, anti-inflammatories, decongestants, antihistamines, non-steroidal anti-inflammatory (NSAID) or cyclooxygenase (COX)-2 inhibitors, antibiotics or antifungals.
- •Presence of other infections which may require use of systemic antibiotics.
- •Known allergy or hypersensitivity to aminoglycosides or other study drug formulation components.
- •Recent hospitalization for any reason and/or major surgeries within 30 days of study screening.
- •Major elective and/or nasal and/or sinus surgical procedures (including sinuplasty) within 90 days before or 90 days after study screening.
- •Known history of neurological or muscular disorders.
- •Diagnosis of an immunodeficiency disease.
- •Previous diagnosis of cystic fibrosis, ciliary dyskinesias, Kartagener syndrome, empty nose syndrome, Wegener granulomatosis, Churg-Strauss syndrome, Samter syndrome, or sarcoidosis.
- •Current or known history of tinnitus, vertigo, or significant sensorineural hearing loss.
- •Recent history of alcohol or drug abuse.
- •Inability to understand the nature, scope, and possible consequences of the study or study procedures, unless cared for by a legally authorized representative.
- •Inability to adhere to the study requirements.
- •Previous participation in any Naryx Pharma protocol.
研究组 & 干预措施
1
Experimental
干预措施: SPRC-AB01 (Drug)
2
Experimental
干预措施: SPRC-AB01 (Drug)
3
Placebo Comparator
干预措施: SPRC-AB01 (Drug)
结局指标
主要结局
Change from baseline in TSSS during first week post-therapy
时间窗: 86 days
次要结局
未报告次要终点
研究者
研究点 (43)
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