EUCTR2008-002707-10-CZ进行中（未招募）不适用
MULTICENTRE, RANDOMIZED, DOUBLE BLIND WITHIN FREQUENCY OF ADMINISTRATION, PLACEBO CONTROLLED, DOSE-FINDING, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF 3 DOSES OF P-3058 NAIL LACQUER (5% o.d., 10% o.d., AND 10% o.w.) GIVEN FOR 52 WEEKS IN PATIENTS WITH ONYCHOMYCOSIS
Polichem SA0 个研究点目标入组 336 人开始时间: 2008年12月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent before starting any study related procedures
- •Patients aged =12 up to 80 years old
- •Males or females, outpatients
- •Patients with established clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis (i.e. involving = 25% to = 60% of the distal bed-adherent nail plate without involvement of the lunula) caused by dermatophytes, affecting at least one big toenail
- •Patients with positive KOH examination from the target big toenail obtained at screening
- •Patients with positive culture for dermatophyte/s in screening nail sample
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant.
- •A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study.
- •Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
- •Patients with liver function impairment AST, ALT more than twice above the upper limit of reference range
- •Patients with kidney function impairment serum creatinine more than twice above the upper limit of reference range
- •History of cancer within the past 5 years, excluding treated basal cell carcinoma
- •Chemotherapy, immunosuppressive therapy in the 12 weeks prior to screening visit
- •Systemic glucocorticosteroids, antimetabolites and immunostimulants therapy in the 4 weeks prior to screening visit
- •Alcohol or substance abuse
- •HIV infection or any other immunodeficiency
- •Patients unable to understand the procedures and purposes of the study
- •Patients with history of allergic reactions to terbinafine or its excipients
- •Use of an investigational drug or participation in an investigational study within 30 days prior to administration of study medication
- •Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to study drug administration until the end of the study
- •Patients with target nail hyperkeratosis exceeding 4 mm in thickness
- •Patients with mucocutaneous candidiasis
- •Patients with white superficial onychomycosis
- •Patients with Yellow spikes on the target nail (extension of fungal infection from distal to proximal part of nail)
- •Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate)
- •Patients with nail abnormalities due to conditions like psoriasis or lichen planus
- •Patients with uncontrolled diabetes
- •Patients with recurrent erysipela at screening visit [If erysipela infection occurs during the study, the patient is allowed to continue the study and to be treated with antibiotic therapy (penicillin)]
- •Use of systemic antifungal drugs in the 6 months prior to screening visit
- •Use of topical products containing terbinafine in the 3 months prior to screening visit
- •Use of topical antifungal drugs (other than terbinafine) in the four weeks prior to screening visit
- •Breast-feeding patients
- •Positive urine pregnancy test at screening
- •Women of child-bearing potential or in menopause for less than 1 year not using a reliable method of contraception.
研究者
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