Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
Completed
Onxeo
Phase 3
2006-07-01
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg
(1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days
of treatment (at the test of cure visit, at Day 17-19).
Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation
Completed
Weill Medical College of Cornell University
Phase 4
2008-02-01
Tacrolimus (Prograf) belongs to a class of medications known as the calcineurin inhibitors.
It is a maintenance drug that is used to prevent rejection in kidney, liver, and heart
transplant recipients. Calcineurin inhibitors display high pharmacokinetic (the body's
effects on a drug) variability and necessitate use of blood tests to ensure that adequate
drug levels are present to maintain effectiveness and safety. Early after transplant or at
times when tacrolimus cannot be taken by mouth, alternative routes of administration are
sought. Although an intravenous (through the vein) product is available, it can be toxic to
the kidneys and has been associated with allergic reactions. Drug delivery via the oral
mucosa is an alternative method of systemic drug administration which offers an alternative
when oral administration is impractical (gastrointestinal dysmotility, reduced drug
absorption, intestinal failure, difficulty in swallowing, or in those with nausea or
vomiting). Administration of tacrolimus by the sublingual route may allow for direct entry
into the systemic circulation and bypasses problems associated with drug absorption and
breakdown that take place in the small intestine.
Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
Completed
Boehringer Ingelheim
Phase 3
2001-05-01
The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole
troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where
this condition has been diagnosed by clinical examination and confirmed by fungal culture.
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