A Comparative Randomized, Double-blind, Double-Dummy, Multicenter Study of the Efficacy and Safety of Miconazole Lauriad 50mg Administered Once a Day and Mycelex Troches (Clotrimazole 10mg) Administered Five Times a Day in the Treatment of Oropharyngeal Candidiasis in Immunocompromised Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 578
- 试验地点
- 26
- 主要终点
- Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale
研究概览
简要总结
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical picture of oropharyngeal candidiasis
- •Confirmation of oropharyngeal candidiasis by candida culture positive
- •HIV-positive patients
- •Patients 18 years of age
排除标准
- •Patients with signs or symptoms of systemic candidiasis
- •Patients with signs or symptoms of esophagitis
- •Pregnant or breast-feeding women
- •Patients who have taken systemic antifungals within the past 30 days
- •Patients who have taken local antifungals within the past 7 days
研究组 & 干预措施
Clotrimazole
Clotrimazole troches, 10 mg, 5 times per day for 14 days
干预措施: Clotrimazole (Drug)
miconazole Lauriad
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
干预措施: miconazole Lauriad (Drug)
结局指标
主要结局
Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale
时间窗: 17 to 22 days
Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.
次要结局
- Clinical Cure at Day 7 (Using Murray Scoring Scale)(7 days)
- Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)(17 to 22 days)
- Clinical Success at Day 7 (Using Murray Scoring Scale)(7 days)
- Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale(17 to 22 days)
- Mycological Cure at the Test of Cure Visit (Day 17-22)(17 to 22 days)
- Relapse at the Late Post-Therapy Visit (Day 35-38)(35 to 38 days)
- Oral Discomfort Using Visual Analog Scale (VAS)(14 days)
- General and Local Tolerability and Oral Discomfort(14 days)
- Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet(14 days)
- Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet(7 days)
- Susceptibility of Candida Species by Microdilution Test(Initiation of treatment to Day 17 to 22)
- Treatment Compliance(Initiation of treatment to Day 14)