NCT00769314已完成3 期
A Randomised, Double-Blind, Single Dose, One-Day Early Administration, Multicentre Study Comparing the Efficacy and Safety of Acyclovir Lauriad® 50 mg Muco-adhesive Buccal Tablet to Matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,727
- 试验地点
- 49
- 主要终点
- Time to Healing (TTH) of Vesicular Primary Lesion
研究概览
简要总结
To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.
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)
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
- •History of recurrent herpes labialis lesions where:
- •At least 50% of previous episodes produced classical lesions to the vesicular stage (i.e. episodes that progressed through macula, papule, vesicle, crust and healed);
- •Prodromal symptoms (itching, tingling, pain etc.) should precede herpes labialis lesions in at least 50% of the previous herpes episodes
- •Good general health (ECOG < 2), immunocompetent
- •Signed and dated written informed consent
- •Women of childbearing potential must have effective contraception method
排除标准
- •More than 50% of recurrences that aborted spontaneously in the past 12 months
- •Primary herpes lesion outside the lips (e.g. nose, chin, etc.)
- •Abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g. eczema, psoriasis...)
- •Oral diseases whose prodromal symptoms may mimick those of herpes labialis, including recurrent oral aphthous disease
- •Oral diseases that might interfere with the evaluation of the efficacy or safety of the treatments, including gingivitis, parondotis, mucositis, oropharyngeal candidiasis...
- •History of infection known to be resistant to acyclovir family agents
- •Previous vaccination against herpes
- •Concomitant treatment likely to interfere with acyclovir
- •Allergy to any acyclovir containing agents
- •Immunocompromised condition, including HIV+
- •Unability to properly understand protocol requirements, to follow the study procedures, to complete the patient diary or to start the self-initiation of the treatment
- •Upper full or partial dentures with acrylic border in the canine fossa
- •Milk allergy or known history of hypersensitivity to one of the components of the products
- •Rare hereditary problems of galactose intolerance.
- •Lactase enzyme deficiency or glucose galactose malabsorption
- •Clinically significant abnormal level of serum creatinine
- •Patients whose occupations make them unlikely to return to the clinic within 24h of treatment initiation
- •Pregnancy or breast-feeding
- •Investigational drug or immunomodulator treatment in the 30 days prior randomisation
- •Prior enrollment in this study
- •Participation in another therapeutic trial evaluating new drugs or which could interfere with the evolution of herpes labialis or the evaluation of the drug in the study within preceding 30 day.
研究组 & 干预措施
1
Experimental
Acyclovir Lauriad 50mg
干预措施: Acyclovir Lauriad (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Healing (TTH) of Vesicular Primary Lesion
时间窗: Assessed from time of treatment initiation through Day 14
Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.
次要结局
- Abortion of Primary Lesions(Assessed from the time of treatment initiation through Day 14)
- TTH of Non-primary Lesions (Aborted Lesions Excluded)(Assessed from the time of treatment initiation through Day 14)
- Duration of Episode (DOE)(Assessed from initiation of treatment to Day 14)
- Time to Cessation of Symptoms(Assessed from time of treatment initiation through Day 14)
- TTH of Aborted Primary Lesions(Assessed from time of treatment initiation through Day 14)
- Time to Recurrence of Non-aborted Lesions During 9-month Follow-up(From time of initial healing through the 9-month follow-up)
- Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up(From time of initial healing through the 9-month follow-up)
- Symptom Intensity (Visual Analogue Scale [VAS])(Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing))
- Patient Satisfaction With Treatment(Assessed on Day 14 (or within 24 hours of healing))
- Patient Assessment of Efficacy of the Treatment(Assessed on Day 14 (or within 24 hours of healing))
研究者
研究点 (49)
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