EUCTR2005-004611-30-BE进行中（未招募）不适用
An open label phase IIa trial to assess efficacy and tolerability of a once a week oral dose of 200 mg R126638 in disto-lateral toenail onychomycosis. - R126638 in toenail onychomycosis
Barrier Therapeutics nv0 个研究点目标入组 20 人开始时间: 2005年12月2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
- 20
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
- •1.Male and female subjects 18 to 70 years old, inclusive.
- •2.Clinical diagnosis of disto-lateral onychomycosis of the toenails.
- •3.Diagnosis confirmed by microscopic examination and culture.
- •4.If the subject is of childbearing potential, she must have a negative urine pregnancy test at inclusion and agree to use effective forms of birth control (double barrier method) during the duration of the clinical trial or until the first menses after 60 days following the last dose of study medication, whichever is longer. She must be on a stable regimen, for at least one month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, IUD, condom and spermicidal agent or diaphragm and spermicidal agent.
- •5.Availability of a signed informed consent prior to beginning protocol-specific procedures, indicating an understanding of the purpose of this trial and a willingness to adhere to the treatment regimen and trial procedures described in this protocol.
- •6.The subject is in good health and free of any disease or physical condition which, in the investigator’s opinion, might impair evaluation of onychomycosis of the toenail(s).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.More than 50% involvement of the most severely affected toenail.
- •2.An involvement of the nail matrix.
- •3.Lateral onychomycosis involving > 50% of the length of the most severely affected toenail.
- •4.Longitudinal yellow streaks on the affected toenail
- •5.Extensive hyperkeratosis (>3mm nail thickness) on the most severely affected toenail.
- •6.Toe nail onychomycosis limited to little toe nails only.
- •7.Psoriasis or diabetes.
- •8.History of significant sensitivity, or significant allergy to azoles or related drugs or any ingredient in the study medication.
- •9.Severe coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive).
- •10.History of heart-failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders.
- •11.Clinically significant abnormal ECG-intervals or morphology of the ECG, QT or QTc>450 ms.
- •12.Use of any local or systemic anti-mycotic therapy two weeks (local) or three months (systemic) before treatment.
- •13.Any use of nail polish or acrylic nails is prohibited on the toenails.
- •14.Medications that reduce gastric acidity may potentially interfere with azole absorption. Use of H2-receptor blockers and proton-pump inhibitors within the 7 days period prior to dosing or within 4 hours after dosing of study medication. Antacids may not be taken within 4 hours after dosing.
- •15.Current use of prohibited medication. CYP3A4 metabolized substrates such as triazolam, oral midazolam, alprazolam, buspirone, Ca-channel blockers such as dihydropyridines and verapamil, tiralazad, fentanyl, alfentanyl, coumarins; CYP3A4 metabolized HMG-CoA reductase inhibitors such as lovastatin, simvastatin, atorvastatin, pravastatin; potent enzyme inducers of CYP3A4, e.g. phenytoin phenobarbital, carbamazepine, isoniazid, rifampin, rifabutin; potent inhibitors of CYP3A4, e.g. ritonavir, indinavir and saquinavir; drugs known to prolong QT-interval such as class Ia and III antiarrythmics, sotalol, terfenadine, astemizole, cisapride, levacetylmethadol (levomethadyl), misolastine, azolastine, antimalarials such as chloroquine, quinidine and halofantrine, macrolides, quinolones, antipsychotics; systemic immunosuppressants e.g. cyclosporine and tacrolimus, rapamycin (sirolimus), methotrexate, 6-mercaptopurine; systemic corticosteroids.
- •16.Out of range laboratory values that the investigators consider as pathologic.
- •17.History or suspicion of alcohol abuse or drug abuse, or psychological or other emotional problems which, in the investigator’s opinion, are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
- •18.Females who are nursing or are pregnant.
- •19.Participation in an investigational study within 30 days prior to study entry.
研究者
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