Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- TMP Closure Ratio
研究概览
简要总结
This study is a double blinded, placebo-controlled phase II study evaluating the efficacy of FGF-2 for the treatment of chronic non-healing tympanic membrane perforations (TMP). The documentation of TM closure will be the main efficacy outcome measure. Pretreatment photographs will document the area of the TM perforation and allow measurement of surface areas of the TMP for comparison of pre- and post-treatment. The study will be divided into two phases, the Randomized Treatment phase (part A), and the Unblinded Crossover phase (part B). In part A of the study, subjects will be randomized 1:1 (using simple randomization) to receive FGF-2 or placebo treatment up to 3 treatments. Subjects that fail three study treatments will move on to part B of the study. Subjects who received placebo in part A and failed three placebo treatments will crossover to receive unblinded FGF-2 for up to 3 treatments. Subjects who received FGF-2 in part A and failed three experimental treatments will not have additional FGF-2 treatment, and will move on to study follow up.
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)
盲法说明
The investigator and the subject will be blinded to treatment assignment during the Randomized Treatment phase.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Dry tympanic membrane perforation of at least 6 months duration
- •Any person of child-bearing potential, must have a negative beta-HCG test and must agree to use an adequate form of birth control throughout the clinical trial.
排除标准
- •Active otitis media or chronic otorrhea from the middle ear
- •Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents, or chemotherapy
- •Subjects who, at study entry, are taking systemic antibiotics
- •Subjects who are immunosuppressed
- •Subjects experiencing bacterial or viral infection or who may otherwise be febrile or may be with inflammation.
- •Life expectancy of less than 1 year
- •Active alcohol or drug abuse within 6 months prior to study entry
- •Significant medical condition that could prevent full participation in the procedures required for the study
- •Known or suspected allergies to any components used in the study, i.e. porcine collagen
- •Subjects who have cholesteatoma mass, or endothelium invasion in the tympanic cavity
- •Subjects whose total perforation cannot be seen by an endoscope
- •Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher)
- •Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility
- •Subjects who have undergone prior myringoplasty or tympanoplasty
- •Subjects whose TMP is a result of thermal burn, or radiation therapy.
- •Subjects who have abnormalities in the auditory ossicles or their linkages
- •Subjects having moderate to severe dementia such as Alzheimer's disease or senile dementia
- •Subjects whose hearing ability does not improve to bone-conduction hearing on a hearing acuity test using the tentative closure of perforation with a wet cotton ball.
- •Subject having residual TM with abnormal form or abnormal shape anatomically
- •Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Human Fibroblast Growth Factor-2 (FGF-2)
干预措施: FGF-2 (Drug)
结局指标
主要结局
TMP Closure Ratio
时间窗: up to Day 134
Determined by otoscopic exam and photographic documentation
次要结局
- Air-Bone Gap (ABG)(up to Day 134)
- Salvage Rate of FGF-2 in Patients who Fail Placebo(Day 64)
- Time to Closure of TMP(up to Day 134)
- Mobility of the Tympanic Membrane(Day 134)
- Pure-tone and speech discrimination scores(Post-treatment 1 (Day 134))
- Pure-tone and speech discrimination scores(Pre-treatment (Day 1))
- Pure-tone and speech discrimination scores(Post-treatment 1 (Day 22))
- Pure-tone and speech discrimination scores(Post-treatment 1 (Day 43))
- Pure-tone and speech discrimination scores(Post-treatment 1 (Day 64))
- Pure-tone and speech discrimination scores(Post-treatment 1 (Day 85))
- Pure-tone and speech discrimination scores(Post-treatment 1 (Day 106))
- Pure-tone and speech discrimination scores(Post-treatment 1 (Day 127))