CTRI/2023/03/051216招募中3 期
RANDOMIZED, DOUBLE BLIND, DOUBLE DUMMY, ACTIVE CONTROLLED,PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OFFOSRAVUCONAZOLE L-LYSINE ETHANOLATE CAPSULES 169.1 MG OF DR.REDDY’S LABORATORIES LIMITED WITH ITRACONAZOLE 200 MG INPATIENTS WITH ONYCHOMYCOSIS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 22
- 主要终点
- Percentage of patients with complete cure (mycological cure + clinical cure) at week 48.
研究概览
简要总结
THE CLINICAL TRIAL IS RANDOMIZED, DOUBLE BLIND, DOUBLE DUMMY, ACTIVE CONTROLLED, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF FOSRAVUCONAZOLE L-LYSINE ETHANOLATE CAPSULES 169.1 MG OF DR. REDDY’S LABORATORIES LIMITED WITH ITRACONAZOLE 200 MG IN PATIENTS WITH ONYCHOMYCOSIS. THE STUDY WILL BE CONDUCTED IN MULTICENTER ACROSS INDIA TO RECRUIT 228 SUBJECT FOR TRIAL
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects between 18 to 65 years of age.
- •Clinical diagnosis of Onychomycosis in atleast one great toenail confirmed by positive mycological culture and microscopic (KOH examination) findings for a dermatophyte.
- •(If both great toenails meet inclusion criteria, the toenail with the greater involvement will be designated the target toenail).
- •Clinical involvement affecting 25% or more of the toenail
- •Willing to comply with protocol requirements and sign a statement of informed consent
- •Willing to refrain from using on the toenails topical products on the affected toenail and to which the subject has a high risk of developing an allergic reaction and/or dermatitis
- •Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period.
- •OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
- •OR Postmenopausal for at least 1 year (at the time of screening).
排除标准
- •History of hypersensitivity or allergy to any of the study drugs or its components
- •Onychomycosis not caused by a dermatophyte (e.g. mold, candida spp.
- •or bacterial infection etc.)
- •History of toenail surgery or any significant injury to the target toenail matrix
- •Significant nail thickening or deformity due to onychogryphosis or other conditions
- •Any systemic or dermatologic disorder, such as psoriasis, severe eczema, or severe atopic dermatitis which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Presence of Superficial white, dystrophy or proximal involvement of the target nail onychomycosis or lichen planus.
- •Structural deformities of the target toenail or foot (eg, genetic or pigment disorders, chemical damage, tumors) that would interfere with treatment procedures or with assessments of efficacy, safety, or tolerability.
- •History or presence of ventricular dysfunction such as congestive heart failure (CHF), cardiac dysrhythmias, ischemic/valvular disease, COPD, peripheral edema, and pulmonary edema and any medical condition that in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol.
- •Uncontrollable diabetes mellitus with HbA1c ≥7%.
- •Female subjects who are Pregnant or lactating.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level exceeding 2 times the upper limit of the normal range.
- •Receipt of any drug as part of a research study within 30 days prior to dosing.
- •Use within the previous 3 months or anticipated use during the study of any drugs that are known to affect the bioavailability of study drugs or are otherwise contraindicated to be taken with the study drugs.
- •Use of any oral or injectable antifungal agent or topical antifungal agent for nails within 36 weeks before the first administration of the study drug
- •Positive test result for HIV, HBV or HCV.
结局指标
主要结局
Percentage of patients with complete cure (mycological cure + clinical cure) at week 48.
时间窗: At week 48
次要结局
- To evaluate the safety and tolerability of Fosravuconazole L-Lysine ethanolate Capsules 169.1mg in comparison with Itraconazole 200 mg for in patients with Onychomycosis.(Percentage of patients with mycological /Complete/Clinical cure at week 12, 24, 36 and 48.)
研究者
研究点 (22)
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