CTRI/2022/05/042655已完成4 期
An open label, prospective, double arm clinical study to compare the effectiveness and safety of super bioavailable Itraconazole capsules 50 mg BD vs 65 mg BD in the management of Glabrous tinea
Dr Deval Mistry1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月23日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint is to evaluate the proportion of patients achieving complete cure at Week 6 following doses of super bioavailable itraconazole 65 mg BD compared to 50 mg BD (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy).
研究概览
简要总结
Open label, prospective, randomized, comparative, double arm study.Eligible patients will be screened and upon confirmation on KOH mount will beenrolled in the study. Efficacy and safety assessments will be done at week 3and week 6. Follow up of all completely cured patients will be done at week 10for recurrence if any as an exploratory endpoint. Quality of Life will beassessed pre and post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients eligible for enrolment in the study must meet all of the following criteria:
- •Both male and female patients aged ≥ 18 years and ≤ 60 years.
- •Patients with diagnosis of Glabrous tinea on KOH mount requiring systemic antifungal therapy.
- •Females of child bearing potential, who is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives).
- •Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
- •Patients who the study staff deems reliable and mentally competent to carry out the study.
排除标准
- •Patients meeting any of the following criteria must not be enrolled in the study:
- •Pregnant or nursing females.
- •Patients with known hypersensitivity to the study drugs.
- •Patients with liver dysfunction.
- •Patients with a history of seizures
- •Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
- •Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
- •History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
- •Patients with malignancy.
- •Any patient whom the investigator judged to be inappropriate for this study.
结局指标
主要结局
The primary efficacy endpoint is to evaluate the proportion of patients achieving complete cure at Week 6 following doses of super bioavailable itraconazole 65 mg BD compared to 50 mg BD (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy).
时间窗: 6 weeks
次要结局
- o The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal and derangement in Liver function test (LFTs) will be summarized by treatment groups(o Percentage of patients achieving clinical cure. (Clinical cure is defined as absence of clinical signs and symptoms at the end of therapy))
研究者
研究点 (1)
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