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Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00390780
Recruitment Status : Completed
First Posted : October 20, 2006
Results First Posted : August 29, 2013
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Onxeo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: miconazole Lauriad
Drug: Clotrimazole
Enrollment 578
Recruitment Details 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
Pre-assignment Details There were no significant events or approaches following participant enrollment and prior to group assignment
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days Clotrimazole troches, 10 mg, 5 times per day, for 14 days
Period Title: Overall Study
Started 291 287
Treatment 290 [1] 287
Completed 268 260
Not Completed 23 27
Reason Not Completed
Not completed             10             4
Protocol Violation             6             4
Lost to Follow-up             3             6
Adverse Event             2             3
Death             1             3
Withdrawal by Subject             1             2
Inclusion criteria not satisfied             0             2
Lost to follow up and other reasons             0             1
Investigator decision, SAE, other reason             0             1
SAE, death             0             1
[1]
One patient randomized to miconazole lost study drug, never started treatment, and was discontinued.
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches Total
Hide Arm/Group Description Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days Clotrimazole troches, 10 mg, 5 times per day for 14 days Total of all reporting groups
Overall Number of Baseline Participants 290 287 577
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 290 participants 287 participants 577 participants
37.5
(18 to 73)
36.5
(18 to 72)
37.0
(18 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
Female
173
  59.7%
168
  58.5%
341
  59.1%
Male
117
  40.3%
119
  41.5%
236
  40.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
United States 67 62 129
Canada 3 3 6
South Africa 220 222 442
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Clinical Cure-ITT 176 187
Clinical Failure-ITT 114 100
Clinical Cure-PP 164 175
Clinical Failure-PP 76 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analyses for ITT and PP populations:

H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value >0.025
Comments Significance level was <0.025
Method one-sided test
Comments [Not Specified]
Method of Estimation Estimation Parameter comparison of proportion clinical cure
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Cure at Day 7 (Using Murray Scoring Scale)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Clinical Cure-ITT 67 71
Clinical Failure-ITT 210 202
Data Missing-ITT 13 14
Clinical Cure-PP 60 63
Clinical Failure-PP 180 173
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analysis for ITT and PP populations:

H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value >0.025
Comments Significance level was <0.025.
Method one-sided noninferiority test
Comments [Not Specified]
Method of Estimation Estimation Parameter comparison of proportion clinical cure
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Clinical Success-ITT 188 199
Clinical Failure-ITT 80 61
Data Missing-ITT 22 27
Clinical Failure-PP 67 51
Clinical Success-PP 173 185
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analysis for ITT population:

H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value 0.0974
Comments Significance level was <0.025.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter compare proportion of clinical success
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analysis for PP population:

H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value 0.1115
Comments Significance level was <0.025.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Compare proportion of clinical success
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Clinical Success at Day 7 (Using Murray Scoring Scale)
Hide Description 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 7 days
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Clinical Success-ITT 92 89
Clinical Failure-ITT 185 184
Data Missing-ITT 13 14
Clinical Success-PP 82 78
Clinical Failure-PP 158 158
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analysis for ITT population:

H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value 0.8787
Comments Significance level was <0.025.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter compare proportion of clinical success
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analysis for PP population:

H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value 0.7969
Comments Significance level was <0.025.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter compare proportion of clinical success
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Partial response-ITT 139 140
Partial response-PP 120 123
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analysis for ITT population:

H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value 0.8820
Comments Significance level was <0.025.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter compare proportion of partial response
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments

Analysis for PP population:

H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Non inferiority assumptions:

Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%

Statistical Test of Hypothesis P-Value 0.9033
Comments Significance level was <0.025.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter compare proportion of partial response
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mycological Cure at the Test of Cure Visit (Day 17-22)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Mycological Cure-ITT 79 71
Mycological Failure-ITT 185 185
Data Missing-ITT 26 31
Mycological Cure-PP 73 64
Mycological Failure-PP 164 168
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority statistical analysis for ITT population.
Statistical Test of Hypothesis P-Value 0.5816
Comments Significance level was <0.025.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in proportion mycologic cure
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority statistical analysis for PP population
Statistical Test of Hypothesis P-Value 0.4439
Comments Significance level was <0.025.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in proportion mycologic cure
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Relapse at the Late Post-Therapy Visit (Day 35-38)
Hide Description "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
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Number of patients-ITT 183 197
Relapse-ITT 51 53
No relapse-ITT 132 144
Not Analyzed-ITT 107 90
Number of patients-PP 168 184
Relapse-PP 45 49
No relapse-PP 123 135
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority statistical analysis for ITT population.
Statistical Test of Hypothesis P-Value 0.8330
Comments Significance level is <0.025.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in proportion relapsed
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority statistical analysis for PP population.
Statistical Test of Hypothesis P-Value 0.9738
Comments Significance level is <0.025.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in proportion relapsed
Estimated Value 0.15
Confidence Interval (1-Sided) 95%
-0.15
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Oral Discomfort Using Visual Analog Scale (VAS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Mean (Full Range)
Unit of Measure: units on a scale
0.8
(0 to 9)
0.4
(0 to 6)
9.Secondary Outcome
Title General and Local Tolerability and Oral Discomfort
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (same as ITT population, includes all randomized patients who took at least one dose of the study medication)
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
Gingival Inflammation-Visit 4 (R canine fossa) 34 26
No Gingival Inflammation-Visit 4 (R canine fossa) 235 233
Data Missing (Inflammation)-Visit 4 (R fossa) 21 28
Gingival Inflammation-Visit 4 (L canine fossa) 30 24
No Gingival Inflammation-Visit 4 (L canine fossa) 239 236
Data Missing (Inflammation)-Visit 4 (L fossa) 21 27
Gum Pain-Visit 4 32 24
No Gum Pain-Visit 4 240 236
Data Missing (Gum Pain)-Visit 4 18 27
Taste of Food Alteration-Visit 4 63 54
No Taste of Food Alteration-Visit 4 209 206
Data Missing (Taste of Food Alteration)-Visit 4 18 27
Taste When Not Eating Alteration-Visit 4 63 52
No Taste When Not Eating Alteration-Visit 4 209 208
Data Missing (Taste When Not Eating)-Visit 4 18 27
Dry Mouth-Visit 4 57 67
No Dry Mouth-Visit 4 215 193
Data Missing (Dry Mouth)-Visit 4 18 27
10.Secondary Outcome
Title Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (all randomized patients who took at least 1 dose of study medication)
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Mean (Full Range)
Unit of Measure: hours
13
(0 to 14)
13
(0 to 14)
11.Secondary Outcome
Title Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
Hide Description Number of patients with detectable plasma concentration at Visit 3 (day 7)
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (all randomized patients who took at least 1 dose of study medication)
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants
0 0
12.Secondary Outcome
Title Susceptibility of Candida Species by Microdilution Test
Hide Description minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
Time Frame Initiation of treatment to Day 17 to 22
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: mcg/ml
Clotrimazole MIC for C. albicans (n=9, 7) 0.0099  (0.0040) 0.0073  (0.0039)
Miconazole MIC for C. albicans (n=9, 7) 0.0764  (0.0995) 0.1664  (0.3679)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments Analysis for Clotrimazole minimum inhibitory concentration (MIC) between treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1860
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Miconazole Lauriad Buccal Tablet, Clotrimazole Troches
Comments Analysis for Miconazole minimum inhibitory concentration (MIC) between treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9564
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Treatment Compliance
Hide Description Number of patients who were 100% compliant with the treatment regimen
Time Frame Initiation of treatment to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (all randomized patients who took at least 1 dose of study medication)
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description:
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: participants compliant
253 250
Time Frame 14 days study treatment, then 21 days of follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Hide Arm/Group Description Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days Clotrimazole troches, 10 mg, 5 times per day for 14 days
All-Cause Mortality
Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/290 (3.45%)      9/287 (3.14%)    
Blood and lymphatic system disorders     
Anaemia  1  3/290 (1.03%)  3 0/287 (0.00%)  0
Disseminated intravascular coagulation  1  1/290 (0.34%)  1 0/287 (0.00%)  0
General disorders     
Death  1  0/290 (0.00%)  0 1/287 (0.35%)  1
Hepatobiliary disorders     
Liver disorder  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Infections and infestations     
AIDS dementia complex  1  1/290 (0.34%)  2 0/287 (0.00%)  0
Disseminated tuberculosis  1  0/290 (0.00%)  0 1/287 (0.35%)  1
Gastroenteritis  1  0/290 (0.00%)  0 1/287 (0.35%)  1
Lower respiratory tract infection  1  2/290 (0.69%)  2 1/287 (0.35%)  1
Meningitis  1  0/290 (0.00%)  0 1/287 (0.35%)  1
Meningitis cryptococcal  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Pneumocystis jiroveci pneumonia  1  1/290 (0.34%)  1 1/287 (0.35%)  1
Pneumonia  1  0/290 (0.00%)  0 2/287 (0.70%)  2
Pulmonary tuberculosis  1  0/290 (0.00%)  0 1/287 (0.35%)  1
Retroviral infection  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Sepsis  1  0/290 (0.00%)  0 1/287 (0.35%)  1
Shigella infection  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/290 (0.34%)  1 1/287 (0.35%)  1
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Reproductive system and breast disorders     
Menorrhagia  1  1/290 (0.34%)  1 0/287 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Miconazole Lauriad Buccal Tablet Clotrimazole Troches
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/290 (29.31%)      84/287 (29.27%)    
Blood and lymphatic system disorders     
Anaemia  1  8/290 (2.76%)  8 5/287 (1.74%)  6
Lymphopenia  1  5/290 (1.72%)  5 6/287 (2.09%)  6
Neutropenia  1  2/290 (0.69%)  2 6/287 (2.09%)  6
Gastrointestinal disorders     
Diarrhea  1  26/290 (8.97%)  30 23/287 (8.01%)  28
Nausea  1  19/290 (6.55%)  25 22/287 (7.67%)  28
Vomiting  1  11/290 (3.79%)  11 9/287 (3.14%)  10
Abdominal pain upper  1  5/290 (1.72%)  5 8/287 (2.79%)  10
Dry mouth  1  8/290 (2.76%)  8 5/287 (1.74%)  5
General disorders     
Fatigue  1  8/290 (2.76%)  9 6/287 (2.09%)  7
Pain  1  3/290 (1.03%)  3 8/287 (2.79%)  9
Infections and infestations     
Gastroenteritis  1  4/290 (1.38%)  4 8/287 (2.79%)  8
Upper respiratory tract infection  1  6/290 (2.07%)  6 7/287 (2.44%)  7
Investigations     
GGT increased  1  3/290 (1.03%)  3 8/287 (2.79%)  8
Nervous system disorders     
Headache  1  22/290 (7.59%)  25 19/287 (6.62%)  23
Ageusia  1  7/290 (2.41%)  9 1/287 (0.35%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/290 (2.76%)  8 5/287 (1.74%)  5
Pharyngolaryngeal pain  1  2/290 (0.69%)  2 7/287 (2.44%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Pierre Attali
Organization: Bioalliance Pharma
Phone: +33 (0)1 45 58 76 00
Responsible Party: Onxeo
ClinicalTrials.gov Identifier: NCT00390780     History of Changes
Other Study ID Numbers: BA/2004/01/04
First Submitted: October 19, 2006
First Posted: October 20, 2006
Results First Submitted: September 7, 2012
Results First Posted: August 29, 2013
Last Update Posted: September 16, 2013