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
Sponsor study identifier
interventional
578
2 countries
27
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
January 2008
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 19, 2006
Actual (reported)October 20, 2006
Actual (reported)December 2007
Actual (reported)January 2008
Actual (reported)August 29, 2013
Actual (reported)Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale
Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.
17 to 22 days
Clinical Cure at Day 7 (Using Murray Scoring Scale)
7 days
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
17 to 22 days
Clinical Success at Day 7 (Using Murray Scoring Scale)
7 days
Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale
17 to 22 days
Mycological Cure at the Test of Cure Visit (Day 17-22)
17 to 22 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
50 mg buccal tablet once a day for 14 days
10mg troches administered Five Times a Day for 14 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama, Department of diagnostic Sciences School of Dentistry
Birmingham, Alabama, 35294-00007, United States
L.A. Gay & Lesbian center, Health & Mental, health services
Los Angeles, California, 90028, United States
East Bay AIDS Center
Oakland, California, 94609, United States
1401 Noth Palm Canyon
Palm Springs, California, 92262, United States
University of Connecticut, School of dental medicine
Farmington, Connecticut, 06030, United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308, United States
578 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2006
First Posted
October 20, 2006
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Fort Lauderdale, Florida, United States
Ryan White Title III Clinic
LaBelle, Florida, 33935, United States
University of Miami
Miami, Florida, 33136, United States
Triple O Medical Services
West Palm Beach, Florida, 21201, United States
Department of oral medicine and diagnostic sciences UIC college of dentistry
Chicago, Illinois, 60612-7213, United States
Plus Clinic, University of Maryland Dental school
Baltimore, Maryland, 21201, United States
Henry Ford Hospital and Wayne State University, Division of infectious diseases
Detroit, Michigan, 48202, United States
AIDS Community Research Initiative of America
New York, New York, 10018, United States
Department Diagnostics Sciences, UNC
Chapel Hill, North Carolina, 27599-7450, United States
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27858, United States
University of Oklahoma, College of medicine
Tulsa, Oklahoma, 74129, United States
Lehigh Valley Hospital Clinical Research Department of Medicine
Allentown, Pennsylvania, 18102, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
Bering Omega Dental Clinic
Houston, Texas, 77006, United States
Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency
Norfolk, Virginia, 23507, United States
Downtown Infectious Disease Clinic
Vancouver, British Columbia, Canada
Providence Health Center British Columbia Centre for excellence in HIV/AIDS
Vancouver, British Columbia, Canada
Health Sciences Center
Winnipeg, Manitoba, GG441-820, Canada
University of Ottawa Health Services
Ottawa, Ontario, Canada
Montreal Chest Institutes immunodeficiency clinic
Montreal, Quebec, H2x2P4, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Primary Completion
December 2007
Actual (reported)Study Completion
January 2008
Actual (reported)Last Updated
September 16, 2013
Results First Posted
August 29, 2013
Record last verified: 2013-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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