COMPARATIVE STUDY OF PHASE 3, RANDOMIZED, DOUBLE BLIND MICAFUNGIN (FK463) VERSUS FLUCONAZOLE FOR THE TREATMENT OF CANDIDIASIS ESOPHAGITIS.

FUJISAWA HEALTH CARE INC,0 个研究点目标入组 0 人开始时间: 2003年7月23日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. The informed consent of the patient or his legally authorized representative must be obtained before entering the study.
•2. Patients can be of both sexes.
•3. Patients 16 years of age or older.
•4. Patients should present candidiasic esophagitis confirmed by endoscopy and documented by typical clinical symptoms within 5 days prior to the administration of the first dose of the study medication. Histological / cytological confirmation should be obtained and by culture of brushing and esophageal biopsy, however the results may still be pending at the time of starting treatment with the study drug.
•5. The patient should have sufficient venous access to allow administration.

•1. Pregnant or nursing patient. Women of childbearing age should avoid pregnancy while receiving the study drug.
•2. Evidence of liver disease, defined either by: a. Aspartate transaminase (AST), alanine transaminase (ALT) or alkaline phosphatase> 10 times the upper limit of the normal value (ULN) .b. Total bilirubin> 5 times ULN.
•3. Patients with another active opportunistic fungal infection and / or receiving acute systemic therapy for an opportunistic fungal infection.
•4. The patient with concomitant esophagitis caused by herpes simplex virus or cytomegalovirus.

发起方

FUJISAWA HEALTH CARE INC,