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Sponsored by: |
BioAlliance Pharma SA |
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Information provided by: | BioAlliance Pharma SA |
ClinicalTrials.gov Identifier: | NCT00390780 |
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).
Condition | Intervention | Phase |
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HIV Infections |
Drug: miconazole Lauriad |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparative Randomized, Double-Blind, Double-Dummy, Multicenter Study of the Efficacy and Safety of Miconazole Lauriad 50mg Administered Once a Day and Mycelex Troches (Clotrimazole 10mg) Administered Five Times a Day in the Treatment of Oropharyngeal Candidiasis in Immunocompromised Patients |
Enrollment: | 578 |
Study Start Date: | July 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | BA/2004/01/04 |
Study First Received: | October 19, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00390780 |
Health Authority: | United States: Food and Drug Administration |
Miconazole Lauriad Oropharyngeal candidiasis HIV patients Mycology |
Clinical picture of Oropharyngeal candidiasis Candida culture positive HIV patients Treatment Experienced |
Sexually Transmitted Diseases, Viral Candidiasis Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole Immunologic Deficiency Syndromes |
Virus Diseases Mycoses HIV Infections Sexually Transmitted Diseases Torulopsis Retroviridae Infections |
Anti-Infective Agents, Local Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Therapeutic Uses Antifungal Agents Lentivirus Infections Infection Pharmacologic Actions |