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9月24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 / her patient must be obtained legally authorized representative before entering the study.
•2. Patients can be of both sexes. Women with the ability to get pregnant should have a negative pregnancy test.
•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 before the administration of the first dose of the medication of the study.
•5. The patient should have enough venous accesses that allow
•administer the study medication and monitor the variables of

•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,