NCT01083875已完成2 期
A Double-blind, Randomized, Vehicle-controlled Phase II Study to Determine the Effects of Concomitant Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
Access Pharmaceuticals, Inc.12 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2000年2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
- 58
- 试验地点
- 12
- 主要终点
- Evaluation of mucositis using the Oral Mucositis Assessment Score
研究概览
简要总结
The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score).
A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.
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
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
- •Patient is 18 years of age or older;
- •Patient has a histologically documented diagnosis of cancer of the head and neck region;
- •Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;
- •This criterion was amended (Amendment 01 dated August 28, 2000) to read as follows:
- •Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:
- •patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
- •with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;
- •Patient has a Karnofsky Performance Scale (KPS) score of 60% or more;
- •Patient is willing and able to cooperate with the protocol including rinsing of the oral cavity with the investigational or vehicle oral rinse 6 times per day.
- •The patient or guardian is capable of providing informed consent.
- •If female, the subject has undergone a urine pregnancy test with negative results, and has agreed to practice effective methods of contraception for the duration of the study.
- •Exclusion criteria
- •Patient has had previous radiation therapy to the oral mucosa;
- •Patient is about to receive hyperfractionated radiation therapy;
- •Patient has active oral H. simplex lesions, oral candidiasis, or oral mucositis due to other disease processes;
- •Patient has uncontrolled infection;
- •Patient has HIV, Hepatitis B (HBV) (as measured by HBs-Ag) or Hepatitis C (HCV) infection;
- •Patient has not recovered from oral toxicity attributable to prior treatment;
- •Patient has abnormal laboratory values that meet the following criteria:
- •Serum creatinine greater than 2 x upper limit of normal
- •Total bilirubin greater than 3 x upper limit of normal;
- •SGOT greater than 3 x upper limit of normal;
- •LDH greater than 3 x upper limit of normal;
- •Patient has known sensitivities to any of the study preparation ingredients;
- •Patient has participated in a clinical research study within the last 30 days prior to enrollment;
- •Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or other reasons.
排除标准
- 未提供
研究组 & 干预措施
0.5% amlexanox oral rinse
Experimental
Patients treated with an oral rinse containing the active 0.5% amlexanox
干预措施: amlexanox (Drug)
Vehicle
Placebo Comparator
Patients treated with an oral rinse containing no active
干预措施: Vehicle rinse (Drug)
结局指标
主要结局
Evaluation of mucositis using the Oral Mucositis Assessment Score
时间窗: 7 weeks
次要结局
- Frequency of treatment-emergent, drug-related Serious Adverse Events(7 weeks)
研究者
研究点 (12)
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