NCT00510263已完成4 期
A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 839
- 主要终点
- The primary endpoint will be the time to complete clinical recovery from Bell's palsy.
研究概览
简要总结
The main objective of this study is to study the effects of prednisolone and valaciclovir, with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination of prednisolone and valaciclovir will also be studied.
详细描述
Study Design:
This is a multicentre randomised double-blind placebo-controlled study.
Study medication:
Prednisolone 60 mg per day for 5 days, after that tapering 10 mg per day for a total treatment time of 10 days. Valaciclovir 1000 mg 3 times per day for 7 days. Prednisolone and valaciclovir are used in combination or separately. One patient of four receives placebo.
Study Duration:
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be in good general health and between 18 and 75 years of age.
- •Have an acute peripheral unilateral idiopathic facial palsy.
- •Not more than 72 hours must have passed after onset of palsy before initiating study medication.
- •The subjects must provide their freely given written informed consent.
排除标准
- •Subjects who have used any antiherpetic medication, except locally applied formulations, within the last 2 weeks.
- •Subjects with ongoing systemic steroid medication for another disease.
- •Pregnant women or nursing mothers.
- •Subjects with diabetes.
- •Subjects presently suffering from gastric or duodenal ulcers. If there is a history of previous peptic ulcers or dyspepsia prophylactic medication must be prescribed and taken during study.
- •Subjects with a history of tuberculosis.
- •Subjects with psychiatric diagnosis that are at risk to be influenced by the study drugs or that might affect the patient´s ability to complete this study.
- •Subjects with a hypertension not well controlled.
- •Subjects with a present, or a history of, serious heart disease.
- •Subjects with a history of glaucoma.
- •Subjects with a history of hepatic disease.
- •Subjects with other neurological diseases.
- •Subjects with a history of renal diseases or a known creatinine clearance of < 30mL/min.
- •Subjects with acute otitis or a history of ipsilateral chronic otitis.
- •Subjects with a history of recent head injury.
- •Fertile, sexually active women not employing acceptable methods of contraception and/or women planning to become pregnant during the period with intake of study medication.
- •Subjects with a history of immunodeficiency syndromes.
- •Subjects with an allergy or sensitivity to aciclovir or valaciclovir, famciclovir or ganciclovir.
研究组 & 干预措施
1
Experimental
干预措施: Prednisolone + placebo (Drug)
2
Experimental
干预措施: Valaciclovir + placebo (Drug)
3
Experimental
干预措施: Prednisolone + valaciclovir (Drug)
4
Placebo Comparator
干预措施: Placebo + placebo (Drug)
结局指标
主要结局
The primary endpoint will be the time to complete clinical recovery from Bell's palsy.
时间窗: 1, 2, 3, 6 or 12 months.
次要结局
- Proportion of patients with complete healing of palsy compared to those with incomplete healing at 12 months after onset.(12 months)
- Influence on outcome at 12 months by time in hours from onset of palsy until beginning of study medication.(12 months)
- Proportion of patients that develop severe palsy during the first week from onset.(One week)
- The total duration of pain, in or around the ipsilateral ear or the ipsilateral side of the face, from onset of palsy.(Two months)
- The proportion of subjects with severe pain (more than VAS 3) in the different treatment arms.(Two months)
- Occurrence of synkinesia in the different treatment arms at any time.(12 months)
- Occurrence of facial spasm or contracture in the different treatment arms at any time.(12 months)
- Severity of remaining facial symptoms in patients not healed at 12 months and at each prescheduled study visit.(12 months)
研究者
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