Trial Outcomes & Findings for Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients (NCT NCT00390780)
NCT ID: NCT00390780
Last Updated: 2013-09-16
Results Overview
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.
COMPLETED
PHASE3
578 participants
17 to 22 days
2013-09-16
Participant Flow
Recruitment from 25 July 06 to 27 December 07 A total of 30 clinical sites (private practice and hospitals) in US, Canada and South Africa screened patients for this study, and 28 sites randomized patients
There were no significant events or approaches following participant enrollment and prior to group assignment
Participant milestones
| Measure |
Miconazole Lauriad Buccal Tablet
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
Clotrimazole troches, 10 mg, 5 times per day, for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
291
|
287
|
|
Overall Study
Treatment
|
290
|
287
|
|
Overall Study
COMPLETED
|
268
|
260
|
|
Overall Study
NOT COMPLETED
|
23
|
27
|
Reasons for withdrawal
| Measure |
Miconazole Lauriad Buccal Tablet
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
Clotrimazole troches, 10 mg, 5 times per day, for 14 days
|
|---|---|---|
|
Overall Study
Not completed
|
10
|
4
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Inclusion criteria not satisfied
|
0
|
2
|
|
Overall Study
Lost to follow up and other reasons
|
0
|
1
|
|
Overall Study
Investigator decision, SAE, other reason
|
0
|
1
|
|
Overall Study
SAE, death
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
Baseline characteristics by cohort
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
Total
n=577 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
37.5 years
FULL_RANGE 9.7 • n=5 Participants
|
36.5 years
FULL_RANGE 9.1 • n=7 Participants
|
37.0 years
FULL_RANGE 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
62 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
220 participants
n=5 Participants
|
222 participants
n=7 Participants
|
442 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 17 to 22 daysPopulation: Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication) Per Protocol (PP, all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)
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.
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per 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
Clinical Cure-ITT
|
176 participants
|
187 participants
|
|
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
Clinical Failure-ITT
|
114 participants
|
100 participants
|
|
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
Clinical Cure-PP
|
164 participants
|
175 participants
|
|
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
Clinical Failure-PP
|
76 participants
|
61 participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication) PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)
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.
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Clinical Cure at Day 7 (Using Murray Scoring Scale)
Clinical Cure-ITT
|
67 participants
|
71 participants
|
|
Clinical Cure at Day 7 (Using Murray Scoring Scale)
Clinical Failure-ITT
|
210 participants
|
202 participants
|
|
Clinical Cure at Day 7 (Using Murray Scoring Scale)
Data Missing-ITT
|
13 participants
|
14 participants
|
|
Clinical Cure at Day 7 (Using Murray Scoring Scale)
Clinical Cure-PP
|
60 participants
|
63 participants
|
|
Clinical Cure at Day 7 (Using Murray Scoring Scale)
Clinical Failure-PP
|
180 participants
|
173 participants
|
SECONDARY outcome
Timeframe: 17 to 22 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication) PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)
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.
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Clinical Success-ITT
|
188 participants
|
199 participants
|
|
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Clinical Failure-ITT
|
80 participants
|
61 participants
|
|
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Data Missing-ITT
|
22 participants
|
27 participants
|
|
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Clinical Failure-PP
|
67 participants
|
51 participants
|
|
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Clinical Success-PP
|
173 participants
|
185 participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication) PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)
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.
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Clinical Success at Day 7 (Using Murray Scoring Scale)
Clinical Success-ITT
|
92 participants
|
89 participants
|
|
Clinical Success at Day 7 (Using Murray Scoring Scale)
Clinical Failure-ITT
|
185 participants
|
184 participants
|
|
Clinical Success at Day 7 (Using Murray Scoring Scale)
Data Missing-ITT
|
13 participants
|
14 participants
|
|
Clinical Success at Day 7 (Using Murray Scoring Scale)
Clinical Success-PP
|
82 participants
|
78 participants
|
|
Clinical Success at Day 7 (Using Murray Scoring Scale)
Clinical Failure-PP
|
158 participants
|
158 participants
|
SECONDARY outcome
Timeframe: 17 to 22 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication) PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)
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
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale
Partial response-ITT
|
139 participants
|
140 participants
|
|
Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale
Partial response-PP
|
120 participants
|
123 participants
|
SECONDARY outcome
Timeframe: 17 to 22 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication) PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)
Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi.
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Mycological Cure at the Test of Cure Visit (Day 17-22)
Mycological Cure-ITT
|
79 participants
|
71 participants
|
|
Mycological Cure at the Test of Cure Visit (Day 17-22)
Mycological Failure-ITT
|
185 participants
|
185 participants
|
|
Mycological Cure at the Test of Cure Visit (Day 17-22)
Data Missing-ITT
|
26 participants
|
31 participants
|
|
Mycological Cure at the Test of Cure Visit (Day 17-22)
Mycological Cure-PP
|
73 participants
|
64 participants
|
|
Mycological Cure at the Test of Cure Visit (Day 17-22)
Mycological Failure-PP
|
164 participants
|
168 participants
|
SECONDARY outcome
Timeframe: 35 to 38 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication) PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)
"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".
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Relapse at the Late Post-Therapy Visit (Day 35-38)
No relapse-PP
|
123 participants
|
135 participants
|
|
Relapse at the Late Post-Therapy Visit (Day 35-38)
Number of patients-ITT
|
183 participants
|
197 participants
|
|
Relapse at the Late Post-Therapy Visit (Day 35-38)
Relapse-ITT
|
51 participants
|
53 participants
|
|
Relapse at the Late Post-Therapy Visit (Day 35-38)
No relapse-ITT
|
132 participants
|
144 participants
|
|
Relapse at the Late Post-Therapy Visit (Day 35-38)
Not Analyzed-ITT
|
107 participants
|
90 participants
|
|
Relapse at the Late Post-Therapy Visit (Day 35-38)
Number of patients-PP
|
168 participants
|
184 participants
|
|
Relapse at the Late Post-Therapy Visit (Day 35-38)
Relapse-PP
|
45 participants
|
49 participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)
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)
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Oral Discomfort Using Visual Analog Scale (VAS)
|
0.8 units on a scale
Interval 0.0 to 9.0
|
0.4 units on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Safety Population (same as ITT population, includes all randomized patients who took at least one dose of the study medication)
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.
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
General and Local Tolerability and Oral Discomfort
Gingival Inflammation-Visit 4 (R canine fossa)
|
34 participants
|
26 participants
|
|
General and Local Tolerability and Oral Discomfort
No Gingival Inflammation-Visit 4 (R canine fossa)
|
235 participants
|
233 participants
|
|
General and Local Tolerability and Oral Discomfort
Data Missing (Inflammation)-Visit 4 (R fossa)
|
21 participants
|
28 participants
|
|
General and Local Tolerability and Oral Discomfort
Data Missing (Inflammation)-Visit 4 (L fossa)
|
21 participants
|
27 participants
|
|
General and Local Tolerability and Oral Discomfort
Gum Pain-Visit 4
|
32 participants
|
24 participants
|
|
General and Local Tolerability and Oral Discomfort
No Gum Pain-Visit 4
|
240 participants
|
236 participants
|
|
General and Local Tolerability and Oral Discomfort
Gingival Inflammation-Visit 4 (L canine fossa)
|
30 participants
|
24 participants
|
|
General and Local Tolerability and Oral Discomfort
No Gingival Inflammation-Visit 4 (L canine fossa)
|
239 participants
|
236 participants
|
|
General and Local Tolerability and Oral Discomfort
Data Missing (Gum Pain)-Visit 4
|
18 participants
|
27 participants
|
|
General and Local Tolerability and Oral Discomfort
Taste of Food Alteration-Visit 4
|
63 participants
|
54 participants
|
|
General and Local Tolerability and Oral Discomfort
No Taste of Food Alteration-Visit 4
|
209 participants
|
206 participants
|
|
General and Local Tolerability and Oral Discomfort
Data Missing (Taste of Food Alteration)-Visit 4
|
18 participants
|
27 participants
|
|
General and Local Tolerability and Oral Discomfort
Taste When Not Eating Alteration-Visit 4
|
63 participants
|
52 participants
|
|
General and Local Tolerability and Oral Discomfort
No Taste When Not Eating Alteration-Visit 4
|
209 participants
|
208 participants
|
|
General and Local Tolerability and Oral Discomfort
Data Missing (Taste When Not Eating)-Visit 4
|
18 participants
|
27 participants
|
|
General and Local Tolerability and Oral Discomfort
Dry Mouth-Visit 4
|
57 participants
|
67 participants
|
|
General and Local Tolerability and Oral Discomfort
No Dry Mouth-Visit 4
|
215 participants
|
193 participants
|
|
General and Local Tolerability and Oral Discomfort
Data Missing (Dry Mouth)-Visit 4
|
18 participants
|
27 participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication)
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
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet
|
13 hours
Interval 0.0 to 14.0
|
13 hours
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT (all randomized patients who took at least 1 dose of study medication)
Number of patients with detectable plasma concentration at Visit 3 (day 7)
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Initiation of treatment to Day 17 to 22Population: ITT (all randomized patients who took at least 1 dose of study medication), nonresponders (participants with progression to a higher visible lesion extent score or no reduction in oral lesion extent score at the test of cure \[Day 17 to 22\] visit)
minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Susceptibility of Candida Species by Microdilution Test
Clotrimazole MIC for C. albicans (n=9, 7)
|
0.0099 mcg/ml
Standard Deviation 0.0040
|
0.0073 mcg/ml
Standard Deviation 0.0039
|
|
Susceptibility of Candida Species by Microdilution Test
Miconazole MIC for C. albicans (n=9, 7)
|
0.0764 mcg/ml
Standard Deviation 0.0995
|
0.1664 mcg/ml
Standard Deviation 0.3679
|
SECONDARY outcome
Timeframe: Initiation of treatment to Day 14Population: ITT (all randomized patients who took at least 1 dose of study medication)
Number of patients who were 100% compliant with the treatment regimen
Outcome measures
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 Participants
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 Participants
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Treatment Compliance
|
253 participants compliant
|
250 participants compliant
|
Adverse Events
Miconazole Lauriad Buccal Tablet
Clotrimazole Troches
Serious adverse events
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 participants at risk
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 participants at risk
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Infections and infestations
AIDS dementia complex
|
0.34%
1/290 • Number of events 2 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
3/290 • Number of events 3 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
General disorders
Death
|
0.00%
0/290 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/290 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/290 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Hepatobiliary disorders
Liver disorder
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Lower respiratory tract infection
|
0.69%
2/290 • Number of events 2 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Meningitis
|
0.00%
0/290 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Meningitis cryptococcal
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Pneumonia
|
0.00%
0/290 • 14 days study treatment, then 21 days of follow-up
|
0.70%
2/287 • Number of events 2 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/290 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Renal and urinary disorders
Renal failure
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Retroviral infection
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Sepsis
|
0.00%
0/290 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Shigella infection
|
0.34%
1/290 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
0.00%
0/287 • 14 days study treatment, then 21 days of follow-up
|
Other adverse events
| Measure |
Miconazole Lauriad Buccal Tablet
n=290 participants at risk
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
|
Clotrimazole Troches
n=287 participants at risk
Clotrimazole troches, 10 mg, 5 times per day for 14 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.0%
26/290 • Number of events 30 • 14 days study treatment, then 21 days of follow-up
|
8.0%
23/287 • Number of events 28 • 14 days study treatment, then 21 days of follow-up
|
|
Gastrointestinal disorders
Nausea
|
6.6%
19/290 • Number of events 25 • 14 days study treatment, then 21 days of follow-up
|
7.7%
22/287 • Number of events 28 • 14 days study treatment, then 21 days of follow-up
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
11/290 • Number of events 11 • 14 days study treatment, then 21 days of follow-up
|
3.1%
9/287 • Number of events 10 • 14 days study treatment, then 21 days of follow-up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
5/290 • Number of events 5 • 14 days study treatment, then 21 days of follow-up
|
2.8%
8/287 • Number of events 10 • 14 days study treatment, then 21 days of follow-up
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
8/290 • Number of events 8 • 14 days study treatment, then 21 days of follow-up
|
1.7%
5/287 • Number of events 5 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Gastroenteritis
|
1.4%
4/290 • Number of events 4 • 14 days study treatment, then 21 days of follow-up
|
2.8%
8/287 • Number of events 8 • 14 days study treatment, then 21 days of follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
6/290 • Number of events 6 • 14 days study treatment, then 21 days of follow-up
|
2.4%
7/287 • Number of events 7 • 14 days study treatment, then 21 days of follow-up
|
|
Nervous system disorders
Headache
|
7.6%
22/290 • Number of events 25 • 14 days study treatment, then 21 days of follow-up
|
6.6%
19/287 • Number of events 23 • 14 days study treatment, then 21 days of follow-up
|
|
Nervous system disorders
Ageusia
|
2.4%
7/290 • Number of events 9 • 14 days study treatment, then 21 days of follow-up
|
0.35%
1/287 • Number of events 1 • 14 days study treatment, then 21 days of follow-up
|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
8/290 • Number of events 8 • 14 days study treatment, then 21 days of follow-up
|
1.7%
5/287 • Number of events 6 • 14 days study treatment, then 21 days of follow-up
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.7%
5/290 • Number of events 5 • 14 days study treatment, then 21 days of follow-up
|
2.1%
6/287 • Number of events 6 • 14 days study treatment, then 21 days of follow-up
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.69%
2/290 • Number of events 2 • 14 days study treatment, then 21 days of follow-up
|
2.1%
6/287 • Number of events 6 • 14 days study treatment, then 21 days of follow-up
|
|
General disorders
Fatigue
|
2.8%
8/290 • Number of events 9 • 14 days study treatment, then 21 days of follow-up
|
2.1%
6/287 • Number of events 7 • 14 days study treatment, then 21 days of follow-up
|
|
General disorders
Pain
|
1.0%
3/290 • Number of events 3 • 14 days study treatment, then 21 days of follow-up
|
2.8%
8/287 • Number of events 9 • 14 days study treatment, then 21 days of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
8/290 • Number of events 8 • 14 days study treatment, then 21 days of follow-up
|
1.7%
5/287 • Number of events 5 • 14 days study treatment, then 21 days of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.69%
2/290 • Number of events 2 • 14 days study treatment, then 21 days of follow-up
|
2.4%
7/287 • Number of events 7 • 14 days study treatment, then 21 days of follow-up
|
|
Investigations
GGT increased
|
1.0%
3/290 • Number of events 3 • 14 days study treatment, then 21 days of follow-up
|
2.8%
8/287 • Number of events 8 • 14 days study treatment, then 21 days of follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60