Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Reduction of pain as judged by visual analogue scale (0 to 10)
研究概览
简要总结
What affect does the use of a mucoadhesive drug delivery system (Mucolox®) compounded with clonazepam have in the treatment of burning mouth syndrome?
There are no clinical trials reported in the literature that evaluate the use of a mucoadhesive vehicle to deliver clonazepam into the oral cavity and treat burning mouth syndrome. The use of a mucoadhesive may help to increase surface contact and elicit a greater reduction in symptoms.
详细描述
Question:
What affect does the use of a mucoadhesive drug delivery system (Mucolox®) compounded with clonazepam have in the treatment of burning mouth syndrome?
There are no clinical trials reported in the literature that evaluate the use of a mucoadhesive vehicle to deliver clonazepam into the oral cavity and treat burning mouth syndrome. The use of a mucoadhesive may help to increase surface contact and elicit a greater reduction in symptoms.
Study Design:
Randomized, single-blind study to be performed with 3 groups (seen below in treatment arms). Randomization will be performed by computer generated randomization to randomly allocate patients. The patients are not aware of the random group allocation. The study will involve assessment at three phases, once at initial examination (baseline), once at two weeks into treatment, and a final assessment at four weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of burning mouth symptoms that cannot be attributed to any other organic cause.
排除标准
- •Laboratory examination will be performed and serum levels of iron, ferritin, folate, vitamin B12 and glucose will be measured. Normal levels required.
- •Use of anxiolytic or antidepressant for less than 6 months prior to study.
- •Resting salivary flow rates less than 0.1ml/min.
- •Presence of oral mucosal disease.
研究组 & 干预措施
Clonazepam
Clonazepam (Klonopin®) treatment arm - 1 mg clonazepam (Klonopin® tablet) TID, dissolved in mouth for 3 minutes then expectorated
干预措施: Clonazepam (Drug)
Mucolox® alone
Mucolox® only - 5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated
干预措施: Mucolox® alone (Drug)
Mucolox® and clonazepam
Mucolox® and clonazepam - 1mg Clonazepam/5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated.
干预措施: Clonazepam mixed with Mucolox® (Drug)
结局指标
主要结局
Reduction of pain as judged by visual analogue scale (0 to 10)
时间窗: 4 weeks
次要结局
- Effect on quality of life issues using the Brief Pain Inventory(4 weeks)