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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
578
50 mg buccal tablet once a day for 14 days
10mg troches administered Five Times a Day for 14 days
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.
Time frame: 17 to 22 days
Clinical Cure at Day 7 (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.
Time frame: 7 days
Clinical Success at Test-of-cure Visit (Day 17-22) (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 success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score \<2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.
Time frame: 17 to 22 days
Clinical Success at Day 7 (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 success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score \<2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.
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University of Alabama, Department of diagnostic Sciences School of Dentistry
Birmingham, Alabama, United States
L.A. Gay & Lesbian center, Health & Mental, health services
Los Angeles, California, United States
East Bay AIDS Center
Oakland, California, United States
1401 Noth Palm Canyon
Palm Springs, California, United States
University of Connecticut, School of dental medicine
Farmington, Connecticut, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Unnamed facility
Fort Lauderdale, Florida, United States
Ryan White Title III Clinic
LaBelle, Florida, United States
University of Miami
Miami, Florida, United States
Triple O Medical Services
West Palm Beach, Florida, United States
...and 17 more locations
Time frame: 7 days
Partial Response at Test of Cure Visit (Days 17-22) 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 success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level
Time frame: 17 to 22 days
Mycological Cure at the Test of Cure Visit (Day 17-22)
Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi.
Time frame: 17 to 22 days
Relapse at the Late Post-Therapy Visit (Day 35-38)
"Number of patients" represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., "clinical success") on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a "clinical success" at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under "Not Analyzed-ITT".
Time frame: 35 to 38 days
Oral Discomfort Using Visual Analog Scale (VAS)
Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort)
Time frame: 14 days
General and Local Tolerability and Oral Discomfort
Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14.
Time frame: 14 days
Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet
The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour
Time frame: 14 days
Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
Number of patients with detectable plasma concentration at Visit 3 (day 7)
Time frame: 7 days
Susceptibility of Candida Species by Microdilution Test
minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
Time frame: Initiation of treatment to Day 17 to 22
Treatment Compliance
Number of patients who were 100% compliant with the treatment regimen
Time frame: Initiation of treatment to Day 14