Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
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
1 other identifier
interventional
578
2 countries
27
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Jul 2006
Shorter than P25 for phase_3 hiv-infections
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 19, 2006
CompletedFirst Posted
Study publicly available on registry
October 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
August 29, 2013
CompletedSeptember 16, 2013
February 1, 2013
1.4 years
October 19, 2006
September 7, 2012
September 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Clotrimazole
ACTIVE COMPARATORClotrimazole troches, 10 mg, 5 times per day for 14 days
miconazole Lauriad
EXPERIMENTALMiconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients with clinical picture of oropharyngeal candidiasis
- Confirmation of oropharyngeal candidiasis by candida culture positive
- HIV-positive patients
- Patients 18 years of age
You may not qualify if:
- Patients with signs or symptoms of systemic candidiasis
- Patients with signs or symptoms of esophagitis
- Pregnant or breast-feeding women
- Patients who have taken systemic antifungals within the past 30 days
- Patients who have taken local antifungals within the past 7 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
Unknown Facility
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Pierre Attali
- Organization
- Bioalliance Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2006
First Posted
October 20, 2006
Study Start
July 1, 2006
Primary Completion
December 1, 2007
Study Completion
January 1, 2008
Last Updated
September 16, 2013
Results First Posted
August 29, 2013
Record last verified: 2013-02